Trial Outcomes & Findings for Evaluating Cancer Survivorship Care Models (NCT NCT02362750)

NCT ID: NCT02362750

Last Updated: 2026-03-25

Results Overview

Patient-reported quality of care was measured using the Survivorship Care Quality Index, which consists of 9 factors and a total of 46 metrics. The factors are then grouped into domains. Domain 1, Informed and grounded patients, consist of 2 factors: 1) delivering mental health and social support, and 2) providing information and resources on the expectations of survivorship care. Domain 2, the patient-provider alliance, consists of 3 factors: 1) feeling empowered to engage in their care, 2) having supportive and respectful clinicians, and 3) having meaningful communication between the patient and clinician. Domain 3, a supportive health and wellness system, consists of 5 factors: 1) coordinating care across providers, 2) preparing patients for transitions in care, 3) having access to a full spectrum of care, 4) providing practical life support, and 5) making sure patients belong to a medical home during this phase of their care.

Recruitment status

COMPLETED

Target enrollment

991 participants

Primary outcome timeframe

Patients complete a survey within one week after their survivorship visit, and 6 months post visit.

Results posted on

2026-03-25

Participant Flow

3 models of survivorship care were identified from the environmental scan of Commission on Cancer-accredited institutions. "High performing institutions" (in quality of care) were recruited from the Assoc, of Community Cancer Centers' and GW Cancer Institute's listservs across the three models model. Institutions recruited participants from their own survivorship care programs. 991 survivors were enrolled at baseline.

Participant milestones

Participant milestones
Measure
Cancer Survivors in Consultative Specialized Survivorship Clinics
Cancer Survivors receiving follow-up care in Consultative Specialized Survivorship Clinic Models. Data collected at (1): Pre-Visit Baseline (2): 1 Week Post-Visit (3): 3 Months Post-Visit (4): 6 Months Post-Visit.
Cancer Survivors in Longitudinal Specialized Survivorship Clinics
Cancer Survivors receiving follow-up care in Longitudinal Specialized Survivorship Clinic Models. Data collected at (1): Pre-Visit Baseline (2): 1 Week Post-Visit (3): 3 Months Post-Visit (4): 6 Months Post-Visit.
Cancer Survivors in Oncology Embedded Survivorship Care Clinics
Cancer Survivors receiving follow-up care in Oncology Embedded Survivorship Care Models. Data collected at (1): Pre-Visit Baseline (2): 1 Week Post-Visit (3): 3 Months Post-Visit (4): 6 Months Post-Visit.
Baseline prior to survivorship visit
STARTED
412
205
374
Baseline prior to survivorship visit
COMPLETED
412
205
374
Baseline prior to survivorship visit
NOT COMPLETED
0
0
0
Within 1 week post survivorship visit
STARTED
412
205
374
Within 1 week post survivorship visit
COMPLETED
393
187
346
Within 1 week post survivorship visit
NOT COMPLETED
19
18
28
3 months post survivorship visit
STARTED
393
187
346
3 months post survivorship visit
COMPLETED
365
175
328
3 months post survivorship visit
NOT COMPLETED
28
12
18
6 months post survivorship visit
STARTED
365
175
328
6 months post survivorship visit
COMPLETED
323
159
295
6 months post survivorship visit
NOT COMPLETED
42
16
33

Reasons for withdrawal

Reasons for withdrawal
Measure
Cancer Survivors in Consultative Specialized Survivorship Clinics
Cancer Survivors receiving follow-up care in Consultative Specialized Survivorship Clinic Models. Data collected at (1): Pre-Visit Baseline (2): 1 Week Post-Visit (3): 3 Months Post-Visit (4): 6 Months Post-Visit.
Cancer Survivors in Longitudinal Specialized Survivorship Clinics
Cancer Survivors receiving follow-up care in Longitudinal Specialized Survivorship Clinic Models. Data collected at (1): Pre-Visit Baseline (2): 1 Week Post-Visit (3): 3 Months Post-Visit (4): 6 Months Post-Visit.
Cancer Survivors in Oncology Embedded Survivorship Care Clinics
Cancer Survivors receiving follow-up care in Oncology Embedded Survivorship Care Models. Data collected at (1): Pre-Visit Baseline (2): 1 Week Post-Visit (3): 3 Months Post-Visit (4): 6 Months Post-Visit.
Within 1 week post survivorship visit
Lost to Follow-up
19
18
28
3 months post survivorship visit
Lost to Follow-up
28
12
18
6 months post survivorship visit
Lost to Follow-up
42
16
33

Baseline Characteristics

Evaluating Cancer Survivorship Care Models

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Consultative Specialized Survivorship Clinic Patients
n=412 Participants
Survivors receiving follow-up care surveys at selected Commission on Cancer-accredited institutions complete four surveys (Survivor Survey (1): Pre-Visit Baseline (2): 1 Week Post-Visit (3): 3 Months Post-Visit (4): 6 Months Post-Visit) regarding their satisfaction, health-related quality of life, ability to manage their cancer post-treatment and appropriate health care utilization. Survivors obtain survivorship care that is organized in a specialized consultative model. In a single, consultative visit that dedicated specifically to survivorship the majority of Tier 1 Essential Elements, including the survivorship care plan (SCP), psychosocial care, health promotion services and symptom management, are provided through direct access during the visit. This model is typically led by a nurse practitioner (NP) or physician's assistant (PA) with specialized training.
Longitudinal Specialized Survivorship Clinic Patients
n=205 Participants
Survivors receiving follow-up care surveys at selected Commission on Cancer-accredited institutions complete four surveys (Survivor Survey (1): Pre-Visit Baseline (2): 1 Week Post-Visit (3): 3 Months Post-Visit (4): 6 Months Post-Visit) regarding their satisfaction, health-related quality of life, ability to manage their cancer post-treatment and appropriate health care utilization. Survivors obtain survivorship care that is organized in a specialized longitudinal model. In a series of survivorship-specific visits scheduled at predetermined intervals and as needed by the patient, the majority of Tier 1 essential elements are provided through direct access onsite rather than through a referral, including the SCP, surveillance for impacts of treatment, screenings for new cancers/recurrences, health promotion education, psychosocial care and symptom management. This model is typically led by an NP or a PA.
Oncology Embedded Model
n=374 Participants
Survivors receiving follow-up care surveys at selected Commission on Cancer-accredited institutions complete four surveys ((1): Pre-Visit Baseline (2): 1 Week Post-Visit (3): 3 Months Post-Visit (4): 6 Months Post-Visit) regarding their satisfaction, health-related quality of life, ability to manage their cancer post-treatment and appropriate health care utilization. Survivorship care is organized in an oncology embedded model, where care is part of standard post-treatment oncology follow-up care. How care is scheduled varies by institution, but is provided in a longitudinal model. Unlike in the Specialized Longitudinal Model, survivorship care is not always provided systematically, and may be on an as needed basis at the request of the patient. Providers likely use referrals to deliver some of the key survivorship services than either of the other two models. This model is typically provided by the treating oncologist, often with support from an NP/PA, patient na
Total
n=991 Participants
Total of all reporting groups
Age, Continuous
59.2 years
STANDARD_DEVIATION 11.7 • n=138 Participants
59.7 years
STANDARD_DEVIATION 12.1 • n=62 Participants
61.8 years
STANDARD_DEVIATION 11.1 • n=123 Participants
60.3 years
STANDARD_DEVIATION 11.6 • n=158 Participants
Sex/Gender, Customized
Female
354 Participants
n=138 Participants
198 Participants
n=62 Participants
305 Participants
n=123 Participants
857 Participants
n=158 Participants
Sex/Gender, Customized
male
57 Participants
n=138 Participants
7 Participants
n=62 Participants
69 Participants
n=123 Participants
133 Participants
n=158 Participants
Sex/Gender, Customized
Missing
1 Participants
n=138 Participants
0 Participants
n=62 Participants
0 Participants
n=123 Participants
1 Participants
n=158 Participants
Race/Ethnicity, Customized
White
332 Participants
n=138 Participants
193 Participants
n=62 Participants
313 Participants
n=123 Participants
838 Participants
n=158 Participants
Race/Ethnicity, Customized
Black
46 Participants
n=138 Participants
4 Participants
n=62 Participants
34 Participants
n=123 Participants
84 Participants
n=158 Participants
Race/Ethnicity, Customized
Other
30 Participants
n=138 Participants
7 Participants
n=62 Participants
21 Participants
n=123 Participants
58 Participants
n=158 Participants
Race/Ethnicity, Customized
unknown/missing
4 Participants
n=138 Participants
1 Participants
n=62 Participants
6 Participants
n=123 Participants
11 Participants
n=158 Participants
Race/Ethnicity, Customized
Ethnicity: Hispanic
11 Participants
n=138 Participants
2 Participants
n=62 Participants
12 Participants
n=123 Participants
25 Participants
n=158 Participants
Race/Ethnicity, Customized
Ethnicity: Non-Hispanic
401 Participants
n=138 Participants
203 Participants
n=62 Participants
362 Participants
n=123 Participants
966 Participants
n=158 Participants
Cancer site
Breast
341 participants
n=138 Participants
195 participants
n=62 Participants
295 participants
n=123 Participants
831 participants
n=158 Participants
Cancer site
Prostate
48 participants
n=138 Participants
4 participants
n=62 Participants
60 participants
n=123 Participants
112 participants
n=158 Participants
Cancer site
Colorectal
23 participants
n=138 Participants
6 participants
n=62 Participants
19 participants
n=123 Participants
48 participants
n=158 Participants
Education
High school/GED grad or less
93 Participants
n=138 Participants
51 Participants
n=62 Participants
131 Participants
n=123 Participants
275 Participants
n=158 Participants
Education
Some college/2-yr degree
127 Participants
n=138 Participants
74 Participants
n=62 Participants
126 Participants
n=123 Participants
327 Participants
n=158 Participants
Education
4-yr college grad
118 Participants
n=138 Participants
51 Participants
n=62 Participants
67 Participants
n=123 Participants
236 Participants
n=158 Participants
Education
Grad school degree
74 Participants
n=138 Participants
28 Participants
n=62 Participants
47 Participants
n=123 Participants
149 Participants
n=158 Participants
Education
Missing
0 Participants
n=138 Participants
1 Participants
n=62 Participants
3 Participants
n=123 Participants
4 Participants
n=158 Participants
Income
<$25,000
78 participants
n=138 Participants
25 participants
n=62 Participants
75 participants
n=123 Participants
178 participants
n=158 Participants
Income
<$25,000 -$74,999
147 participants
n=138 Participants
109 participants
n=62 Participants
163 participants
n=123 Participants
419 participants
n=158 Participants
Income
$75,000+
145 participants
n=138 Participants
57 participants
n=62 Participants
94 participants
n=123 Participants
296 participants
n=158 Participants
Marital Status
Married/Living with Partner
266 participants
n=138 Participants
137 participants
n=62 Participants
248 participants
n=123 Participants
651 participants
n=158 Participants
Marital Status
Widowed
113 participants
n=138 Participants
57 participants
n=62 Participants
95 participants
n=123 Participants
265 participants
n=158 Participants
Marital Status
Divorced/Separated
33 participants
n=138 Participants
9 participants
n=62 Participants
29 participants
n=123 Participants
71 participants
n=158 Participants
Employment Status
Working (as paid employee)
197 Participants
n=138 Participants
96 Participants
n=62 Participants
149 Participants
n=123 Participants
442 Participants
n=158 Participants
Employment Status
Self-Employed
43 Participants
n=138 Participants
20 Participants
n=62 Participants
50 Participants
n=123 Participants
113 Participants
n=158 Participants
Employment Status
Not working (including retired and disabled)
171 Participants
n=138 Participants
88 Participants
n=62 Participants
175 Participants
n=123 Participants
434 Participants
n=158 Participants
Employment Status
Missing
1 Participants
n=138 Participants
1 Participants
n=62 Participants
0 Participants
n=123 Participants
2 Participants
n=158 Participants
Stage of Cancer Diagnosis
Stage 0 - cancer in situ; the cancer is still in the place it started
37 Participants
n=138 Participants
11 Participants
n=62 Participants
46 Participants
n=123 Participants
94 Participants
n=158 Participants
Stage of Cancer Diagnosis
Stage 1 - cancer that has not grown deeply into nearby tissue
146 Participants
n=138 Participants
78 Participants
n=62 Participants
133 Participants
n=123 Participants
357 Participants
n=158 Participants
Recurrence or Diagnosis of New Cancer
At 6 months
6 participants
n=138 Participants
0 participants
n=62 Participants
8 participants
n=123 Participants
14 participants
n=158 Participants
Stage of Cancer Diagnosis
Stage 2 - cancer has grown deeply into nearby tissue
131 Participants
n=138 Participants
66 Participants
n=62 Participants
92 Participants
n=123 Participants
289 Participants
n=158 Participants
Stage of Cancer Diagnosis
Stage 3 - cancer has grown deeply into nearby tissue and may have spread to lymph nodes
48 Participants
n=138 Participants
20 Participants
n=62 Participants
37 Participants
n=123 Participants
105 Participants
n=158 Participants
Stage of Cancer Diagnosis
Stage 4 - cancer has metasticized and spread to other organs or parts of the body
5 Participants
n=138 Participants
2 Participants
n=62 Participants
4 Participants
n=123 Participants
11 Participants
n=158 Participants
Stage of Cancer Diagnosis
Don't know
40 Participants
n=138 Participants
25 Participants
n=62 Participants
55 Participants
n=123 Participants
120 Participants
n=158 Participants
Stage of Cancer Diagnosis
Missing
5 Participants
n=138 Participants
3 Participants
n=62 Participants
7 Participants
n=123 Participants
15 Participants
n=158 Participants
Treatments Completed
Surgery
349 participants
n=138 Participants
198 participants
n=62 Participants
303 participants
n=123 Participants
850 participants
n=158 Participants
Treatments Completed
Chemotherapy, target therapy or immunotherapy
202 participants
n=138 Participants
94 participants
n=62 Participants
138 participants
n=123 Participants
434 participants
n=158 Participants
Treatments Completed
Radiation
325 participants
n=138 Participants
139 participants
n=62 Participants
315 participants
n=123 Participants
779 participants
n=158 Participants
Treatments Completed
Other
9 participants
n=138 Participants
13 participants
n=62 Participants
11 participants
n=123 Participants
33 participants
n=158 Participants
Receiving Hormone Therapy
No (have not and will not)
126 Participants
n=138 Participants
56 Participants
n=62 Participants
125 Participants
n=123 Participants
307 Participants
n=158 Participants
Receiving Hormone Therapy
Currently receiving
241 Participants
n=138 Participants
125 Participants
n=62 Participants
203 Participants
n=123 Participants
569 Participants
n=158 Participants
Receiving Hormone Therapy
Completed/ will start
32 Participants
n=138 Participants
19 Participants
n=62 Participants
31 Participants
n=123 Participants
82 Participants
n=158 Participants
Receiving Hormone Therapy
Missing
13 Participants
n=138 Participants
5 Participants
n=62 Participants
15 Participants
n=123 Participants
33 Participants
n=158 Participants
Recurrence or Diagnosis of New Cancer
At 3 months
5 participants
n=138 Participants
0 participants
n=62 Participants
5 participants
n=123 Participants
10 participants
n=158 Participants

PRIMARY outcome

Timeframe: Patients complete a survey within one week after their survivorship visit, and 6 months post visit.

Patient-reported quality of care was measured using the Survivorship Care Quality Index, which consists of 9 factors and a total of 46 metrics. The factors are then grouped into domains. Domain 1, Informed and grounded patients, consist of 2 factors: 1) delivering mental health and social support, and 2) providing information and resources on the expectations of survivorship care. Domain 2, the patient-provider alliance, consists of 3 factors: 1) feeling empowered to engage in their care, 2) having supportive and respectful clinicians, and 3) having meaningful communication between the patient and clinician. Domain 3, a supportive health and wellness system, consists of 5 factors: 1) coordinating care across providers, 2) preparing patients for transitions in care, 3) having access to a full spectrum of care, 4) providing practical life support, and 5) making sure patients belong to a medical home during this phase of their care.

Outcome measures

Outcome measures
Measure
Survivors in Consultative Specialized Survivorship Clinic Model: Within 1 Week Post-Visit
n=393 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Consultative Specialized Survivorship Clinic (CSSC) with Direct Access. This model provides consultative survivorship care after treatment has ended through a single visit dedicated specifically to survivorship. The majority of Tier 1 Essential Elements, including the survivorship care plan (SCP), psychosocial care, health promotion services and symptom management, are provided through direct access during the survivorship visit. This model is typically led by a nurse practitioner (NP) or physician's assistant (PA) with specialized training.
Survivors in Consultative Specialized Survivorship Clinic Model: 6 Months Post-Visit
n=323 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Consultative Specialized Survivorship Clinic (CSSC) with Direct Access. This model provides consultative survivorship care after treatment has ended through a single visit dedicated specifically to survivorship. The majority of Tier 1 Essential Elements, including the survivorship care plan (SCP), psychosocial care, health promotion services and symptom management, are provided through direct access during the survivorship visit. This model is typically led by a nurse practitioner (NP) or physician's assistant (PA) with specialized training.
Survivors in Longitudinal Specialized Survivorship Clinic Model: Within 1 Week Post-Visit
n=187 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Longitudinal Specialized Survivorship Clinic (LSSC) with Direct Access. This model provides ongoing survivorship care through a series of survivorship-specific visits scheduled at predetermined intervals and as needed by the patient. The majority of Tier 1 essential elements are provided through direct access onsite rather than through a referral, including the SCP, surveillance for impacts of treatment, screenings for new cancers/recurrences, health promotion education, psychosocial care and symptom management. This model is typically led by an NP or a PA.
Survivors in Longitudinal Specialized Clinic Model: 6 Months Post-Visit
n=159 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Longitudinal Specialized Survivorship Clinic (LSSC) with Direct Access. This model provides ongoing survivorship care through a series of survivorship-specific visits scheduled at predetermined intervals and as needed by the patient. The majority of Tier 1 essential elements are provided through direct access onsite rather than through a referral, including the SCP, surveillance for impacts of treatment, screenings for new cancers/recurrences, health promotion education, psychosocial care and symptom management. This model is typically led by an NP or a PA.
Survivors in Oncology Embedded Survivorship Clinic Model: Within 1 Week Post-Visit
n=346 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Survivors in Oncology Embedded Survivorship Clinic Model: 6 Months Post-Visit
n=295 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Oncology Embedded Survivorship Clinic Model: End of Treatment-Baseline
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Oncology Embedded Survivorship Clinic Model: 0-3 Months Post Visit
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Oncology Embedded Survivorship Clinic Model: 3-6 Months Post Visit
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Percentage of Survivors Reporting "Yes Definitely" Across Items Within Each of 9 Factors Reflecting Survivorship Care Quality
Emotional and social support
33.1 percentage of participants
14.8 percentage of participants
30.7 percentage of participants
18.9 percentage of participants
20.2 percentage of participants
12.6 percentage of participants
Percentage of Survivors Reporting "Yes Definitely" Across Items Within Each of 9 Factors Reflecting Survivorship Care Quality
Information and Resources
75.5 percentage of participants
60.2 percentage of participants
73.9 percentage of participants
59.6 percentage of participants
65.9 percentage of participants
60.6 percentage of participants
Percentage of Survivors Reporting "Yes Definitely" Across Items Within Each of 9 Factors Reflecting Survivorship Care Quality
Empowered and Engaged Patients
59.0 percentage of participants
57.6 percentage of participants
60.7 percentage of participants
59.8 percentage of participants
50.5 percentage of participants
59.3 percentage of participants
Percentage of Survivors Reporting "Yes Definitely" Across Items Within Each of 9 Factors Reflecting Survivorship Care Quality
Supportive and Prepared Clinicians
59.9 percentage of participants
60.2 percentage of participants
58.7 percentage of participants
62.3 percentage of participants
56.4 percentage of participants
59.1 percentage of participants
Percentage of Survivors Reporting "Yes Definitely" Across Items Within Each of 9 Factors Reflecting Survivorship Care Quality
Open Patient-Clinician Communication
88.4 percentage of participants
86.3 percentage of participants
89.3 percentage of participants
88.4 percentage of participants
84.2 percentage of participants
87.5 percentage of participants
Percentage of Survivors Reporting "Yes Definitely" Across Items Within Each of 9 Factors Reflecting Survivorship Care Quality
Care Coordination and Transitions in Care
53.1 percentage of participants
57.3 percentage of participants
54.8 percentage of participants
59.1 percentage of participants
50.3 percentage of participants
57.5 percentage of participants
Percentage of Survivors Reporting "Yes Definitely" Across Items Within Each of 9 Factors Reflecting Survivorship Care Quality
Provision of Full Spectrum of Care
45.4 percentage of participants
41.4 percentage of participants
44.8 percentage of participants
45.9 percentage of participants
34.6 percentage of participants
39.7 percentage of participants
Percentage of Survivors Reporting "Yes Definitely" Across Items Within Each of 9 Factors Reflecting Survivorship Care Quality
Practical Life Support/ Health Insurance Issues
12 percentage of participants
8 percentage of participants
9.3 percentage of participants
13.2 percentage of participants
9.4 percentage of participants
14.8 percentage of participants
Percentage of Survivors Reporting "Yes Definitely" Across Items Within Each of 9 Factors Reflecting Survivorship Care Quality
Medical Home
77.0 percentage of participants
82.3 percentage of participants
75.7 percentage of participants
84.0 percentage of participants
75.8 percentage of participants
82.9 percentage of participants

PRIMARY outcome

Timeframe: Patients complete a survey at baseline before their survivorship visit, and 6 months post visit.

Patient-reported quality of life concerns were measured using an index with 3 factors that represent physical concerns (consists of 8 metrics), social and emotional concerns (6 metrics), and practical concerns (2 metrics). The prevalence of top concerns in each domain were calculated. The top concerns were defined as those with \>40% prevalence at baseline across all three models. For physical concerns individuals received scores ranging from 0/8 to 8/8, for social/emotional concerns individuals were scored 0/6 to 6/6, and for practical concerns they were scored 0/2 to 2/2. The number presented is the average of those individual scores, converted into a percentage. The higher the number the more concerns participants reported

Outcome measures

Outcome measures
Measure
Survivors in Consultative Specialized Survivorship Clinic Model: Within 1 Week Post-Visit
n=412 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Consultative Specialized Survivorship Clinic (CSSC) with Direct Access. This model provides consultative survivorship care after treatment has ended through a single visit dedicated specifically to survivorship. The majority of Tier 1 Essential Elements, including the survivorship care plan (SCP), psychosocial care, health promotion services and symptom management, are provided through direct access during the survivorship visit. This model is typically led by a nurse practitioner (NP) or physician's assistant (PA) with specialized training.
Survivors in Consultative Specialized Survivorship Clinic Model: 6 Months Post-Visit
n=323 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Consultative Specialized Survivorship Clinic (CSSC) with Direct Access. This model provides consultative survivorship care after treatment has ended through a single visit dedicated specifically to survivorship. The majority of Tier 1 Essential Elements, including the survivorship care plan (SCP), psychosocial care, health promotion services and symptom management, are provided through direct access during the survivorship visit. This model is typically led by a nurse practitioner (NP) or physician's assistant (PA) with specialized training.
Survivors in Longitudinal Specialized Survivorship Clinic Model: Within 1 Week Post-Visit
n=205 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Longitudinal Specialized Survivorship Clinic (LSSC) with Direct Access. This model provides ongoing survivorship care through a series of survivorship-specific visits scheduled at predetermined intervals and as needed by the patient. The majority of Tier 1 essential elements are provided through direct access onsite rather than through a referral, including the SCP, surveillance for impacts of treatment, screenings for new cancers/recurrences, health promotion education, psychosocial care and symptom management. This model is typically led by an NP or a PA.
Survivors in Longitudinal Specialized Clinic Model: 6 Months Post-Visit
n=159 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Longitudinal Specialized Survivorship Clinic (LSSC) with Direct Access. This model provides ongoing survivorship care through a series of survivorship-specific visits scheduled at predetermined intervals and as needed by the patient. The majority of Tier 1 essential elements are provided through direct access onsite rather than through a referral, including the SCP, surveillance for impacts of treatment, screenings for new cancers/recurrences, health promotion education, psychosocial care and symptom management. This model is typically led by an NP or a PA.
Survivors in Oncology Embedded Survivorship Clinic Model: Within 1 Week Post-Visit
n=374 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Survivors in Oncology Embedded Survivorship Clinic Model: 6 Months Post-Visit
n=295 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Oncology Embedded Survivorship Clinic Model: End of Treatment-Baseline
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Oncology Embedded Survivorship Clinic Model: 0-3 Months Post Visit
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Oncology Embedded Survivorship Clinic Model: 3-6 Months Post Visit
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Average Number of Quality of Life Top Concerns Reported Converted to a Percentage
Top Social and Emotional Concerns
61.0 average number converted to a percentage
Standard Deviation .36
58.1 average number converted to a percentage
Standard Deviation .35
61.1 average number converted to a percentage
Standard Deviation .37
63.6 average number converted to a percentage
Standard Deviation .34
53.6 average number converted to a percentage
Standard Deviation .36
54.2 average number converted to a percentage
Standard Deviation .36
Average Number of Quality of Life Top Concerns Reported Converted to a Percentage
Top Practical Concerns
42.7 average number converted to a percentage
Standard Deviation .46
38.7 average number converted to a percentage
Standard Deviation .45
41.5 average number converted to a percentage
Standard Deviation .45
42.1 average number converted to a percentage
Standard Deviation .47
44.5 average number converted to a percentage
Standard Deviation .46
33.7 average number converted to a percentage
Standard Deviation .45
Average Number of Quality of Life Top Concerns Reported Converted to a Percentage
Top Physical Concerns
56.5 average number converted to a percentage
Standard Deviation .30
54.5 average number converted to a percentage
Standard Deviation .36
52.6 average number converted to a percentage
Standard Deviation .30
58.3 average number converted to a percentage
Standard Deviation .33
50.7 average number converted to a percentage
Standard Deviation .31
53.1 average number converted to a percentage
Standard Deviation .36

PRIMARY outcome

Timeframe: Patients complete a survey at baseline before their survivorship visit, within one week after their survivorship visit, 3 months post visit, and 6 months post visit.

Population: Participant population differs across rows because of lost to follow up in the study over time

Patient-reported self-efficacy was measured as the mean score of 8 metrics, reflecting how confident patients are that they can take care of different aspects of their health and health care after treatment has ended on a scale from 0 to 5, where 0=not at all confident and 5=totally confident.

Outcome measures

Outcome measures
Measure
Survivors in Consultative Specialized Survivorship Clinic Model: Within 1 Week Post-Visit
n=412 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Consultative Specialized Survivorship Clinic (CSSC) with Direct Access. This model provides consultative survivorship care after treatment has ended through a single visit dedicated specifically to survivorship. The majority of Tier 1 Essential Elements, including the survivorship care plan (SCP), psychosocial care, health promotion services and symptom management, are provided through direct access during the survivorship visit. This model is typically led by a nurse practitioner (NP) or physician's assistant (PA) with specialized training.
Survivors in Consultative Specialized Survivorship Clinic Model: 6 Months Post-Visit
n=205 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Consultative Specialized Survivorship Clinic (CSSC) with Direct Access. This model provides consultative survivorship care after treatment has ended through a single visit dedicated specifically to survivorship. The majority of Tier 1 Essential Elements, including the survivorship care plan (SCP), psychosocial care, health promotion services and symptom management, are provided through direct access during the survivorship visit. This model is typically led by a nurse practitioner (NP) or physician's assistant (PA) with specialized training.
Survivors in Longitudinal Specialized Survivorship Clinic Model: Within 1 Week Post-Visit
n=374 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Longitudinal Specialized Survivorship Clinic (LSSC) with Direct Access. This model provides ongoing survivorship care through a series of survivorship-specific visits scheduled at predetermined intervals and as needed by the patient. The majority of Tier 1 essential elements are provided through direct access onsite rather than through a referral, including the SCP, surveillance for impacts of treatment, screenings for new cancers/recurrences, health promotion education, psychosocial care and symptom management. This model is typically led by an NP or a PA.
Survivors in Longitudinal Specialized Clinic Model: 6 Months Post-Visit
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Longitudinal Specialized Survivorship Clinic (LSSC) with Direct Access. This model provides ongoing survivorship care through a series of survivorship-specific visits scheduled at predetermined intervals and as needed by the patient. The majority of Tier 1 essential elements are provided through direct access onsite rather than through a referral, including the SCP, surveillance for impacts of treatment, screenings for new cancers/recurrences, health promotion education, psychosocial care and symptom management. This model is typically led by an NP or a PA.
Survivors in Oncology Embedded Survivorship Clinic Model: Within 1 Week Post-Visit
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Survivors in Oncology Embedded Survivorship Clinic Model: 6 Months Post-Visit
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Oncology Embedded Survivorship Clinic Model: End of Treatment-Baseline
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Oncology Embedded Survivorship Clinic Model: 0-3 Months Post Visit
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Oncology Embedded Survivorship Clinic Model: 3-6 Months Post Visit
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Self- Efficacy Score
Pre-Visit Baseline
3.94 Average Self-Efficacy Score (0-5 scale)
Standard Deviation .78
3.89 Average Self-Efficacy Score (0-5 scale)
Standard Deviation .78
4.03 Average Self-Efficacy Score (0-5 scale)
Standard Deviation .73
Self- Efficacy Score
1 Week Post-Visit
4.26 Average Self-Efficacy Score (0-5 scale)
Standard Deviation .59
4.25 Average Self-Efficacy Score (0-5 scale)
Standard Deviation .59
4.26 Average Self-Efficacy Score (0-5 scale)
Standard Deviation .59
Self- Efficacy Score
3 Month Post-Visit
4.02 Average Self-Efficacy Score (0-5 scale)
Standard Deviation .74
4.03 Average Self-Efficacy Score (0-5 scale)
Standard Deviation .73
4.11 Average Self-Efficacy Score (0-5 scale)
Standard Deviation .71
Self- Efficacy Score
6 Month Post-Visit
4.09 Average Self-Efficacy Score (0-5 scale)
Standard Deviation .75
4.07 Average Self-Efficacy Score (0-5 scale)
Standard Deviation .68
4.20 Average Self-Efficacy Score (0-5 scale)
Standard Deviation .69

PRIMARY outcome

Timeframe: Patients complete a survey at baseline before their survivorship visit, 3 months post visit, and 6 months post visit.

Number of visits to health care providers at 3 different time points: end of treatment- baseline pre-survivorship visit, 0-3 months and 3-6 months post survivorship visit. The data presented are the mean (SD) number of visits to specific providers over time, by model.

Outcome measures

Outcome measures
Measure
Survivors in Consultative Specialized Survivorship Clinic Model: Within 1 Week Post-Visit
n=412 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Consultative Specialized Survivorship Clinic (CSSC) with Direct Access. This model provides consultative survivorship care after treatment has ended through a single visit dedicated specifically to survivorship. The majority of Tier 1 Essential Elements, including the survivorship care plan (SCP), psychosocial care, health promotion services and symptom management, are provided through direct access during the survivorship visit. This model is typically led by a nurse practitioner (NP) or physician's assistant (PA) with specialized training.
Survivors in Consultative Specialized Survivorship Clinic Model: 6 Months Post-Visit
n=365 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Consultative Specialized Survivorship Clinic (CSSC) with Direct Access. This model provides consultative survivorship care after treatment has ended through a single visit dedicated specifically to survivorship. The majority of Tier 1 Essential Elements, including the survivorship care plan (SCP), psychosocial care, health promotion services and symptom management, are provided through direct access during the survivorship visit. This model is typically led by a nurse practitioner (NP) or physician's assistant (PA) with specialized training.
Survivors in Longitudinal Specialized Survivorship Clinic Model: Within 1 Week Post-Visit
n=323 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Longitudinal Specialized Survivorship Clinic (LSSC) with Direct Access. This model provides ongoing survivorship care through a series of survivorship-specific visits scheduled at predetermined intervals and as needed by the patient. The majority of Tier 1 essential elements are provided through direct access onsite rather than through a referral, including the SCP, surveillance for impacts of treatment, screenings for new cancers/recurrences, health promotion education, psychosocial care and symptom management. This model is typically led by an NP or a PA.
Survivors in Longitudinal Specialized Clinic Model: 6 Months Post-Visit
n=205 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through a Longitudinal Specialized Survivorship Clinic (LSSC) with Direct Access. This model provides ongoing survivorship care through a series of survivorship-specific visits scheduled at predetermined intervals and as needed by the patient. The majority of Tier 1 essential elements are provided through direct access onsite rather than through a referral, including the SCP, surveillance for impacts of treatment, screenings for new cancers/recurrences, health promotion education, psychosocial care and symptom management. This model is typically led by an NP or a PA.
Survivors in Oncology Embedded Survivorship Clinic Model: Within 1 Week Post-Visit
n=175 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Survivors in Oncology Embedded Survivorship Clinic Model: 6 Months Post-Visit
n=159 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Oncology Embedded Survivorship Clinic Model: End of Treatment-Baseline
n=374 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Oncology Embedded Survivorship Clinic Model: 0-3 Months Post Visit
n=328 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Oncology Embedded Survivorship Clinic Model: 3-6 Months Post Visit
n=295 Participants
Non-metastatic breast, prostate and colorectal cancer survivors receiving survivorship care through Oncology Embedded Survivorship Clinics (OESC) with Varied Access. This model provides survivorship care as part of standard post-treatment oncology follow-up care. Because this model integrates survivorship with standard follow-up care, it is considered a longitudinal model, though institutions also report survivorship is not always provided systematically as in Model 2 but rather on an as needed basis at the request of the patient. Institutions with the Embedded model are more likely to use referrals to deliver some of the key survivorship services than either of the other two models. Survivorship care in this model is typically provided by the treating oncologist often with support from an NP/PA, patient navigator or social worker.
Frequency of Visit
Primary Care Physician
.71 mean number of visits
Standard Deviation 1.3
1.0 mean number of visits
Standard Deviation 1.2
.91 mean number of visits
Standard Deviation 1.3
.77 mean number of visits
Standard Deviation 1.4
.90 mean number of visits
Standard Deviation 1.0
.76 mean number of visits
Standard Deviation .9
.78 mean number of visits
Standard Deviation 1.4
1.1 mean number of visits
Standard Deviation 1.3
.88 mean number of visits
Standard Deviation 1.1
Frequency of Visit
Oncology
1.59 mean number of visits
Standard Deviation 1.8
1.15 mean number of visits
Standard Deviation 1.0
.97 mean number of visits
Standard Deviation 1.0
2.22 mean number of visits
Standard Deviation 2.2
1.31 mean number of visits
Standard Deviation 1.4
1.09 mean number of visits
Standard Deviation 1.3
1.77 mean number of visits
Standard Deviation 2.1
1.32 mean number of visits
Standard Deviation 1.2
1.09 mean number of visits
Standard Deviation 1.1
Frequency of Visit
Hospital
.49 mean number of visits
Standard Deviation 1.5
.51 mean number of visits
Standard Deviation 1.5
.41 mean number of visits
Standard Deviation 1.1
.22 mean number of visits
Standard Deviation .71
.34 mean number of visits
Standard Deviation 1.1
.27 mean number of visits
Standard Deviation .68
.54 mean number of visits
Standard Deviation 1.8
.55 mean number of visits
Standard Deviation 1.2
.58 mean number of visits
Standard Deviation 1.2
Frequency of Visit
Other Specialists
1.6 mean number of visits
Standard Deviation 2.7
1.94 mean number of visits
Standard Deviation 2.9
1.33 mean number of visits
Standard Deviation 2.5
2.0 mean number of visits
Standard Deviation 3.5
2.14 mean number of visits
Standard Deviation 3.2
1.71 mean number of visits
Standard Deviation 2.9
1.45 mean number of visits
Standard Deviation 2.5
1.73 mean number of visits
Standard Deviation 2.7
1.13 mean number of visits
Standard Deviation 2.0

Adverse Events

Cancer Survivors in Consultative Specialized Survivorship Clinic Model

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cancer Survivors in Longitudinal Specialized Survivorship Clinic Model

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cancer Survivors in Oncology Embedded Survivorship Clinic Model

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

K. Holly Mead

GW University

Phone: 202-994-8615

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place