Trial Outcomes & Findings for Navigation vs Usual Care for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC (NCT NCT04030130)
NCT ID: NCT04030130
Last Updated: 2025-01-29
Results Overview
defined per National Comprehensive Cancer Network Guidelines as the initiation of PORT \> 6 weeks (42 days) following definitive surgery for HNSCC
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
176 participants
Primary outcome timeframe
6 weeks after surgery
Results posted on
2025-01-29
Participant Flow
Participant milestones
| Measure |
NDURE
NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model \[HBM\]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.
|
Usual Care
UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
88
|
|
Overall Study
COMPLETED
|
88
|
88
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Navigation vs Usual Care for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC
Baseline characteristics by cohort
| Measure |
NDURE
n=88 Participants
NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model \[HBM\]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.
|
Usual Care
n=88 Participants
UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
62.2 years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
62.2 years
STANDARD_DEVIATION 11.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
176 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
88 participants
n=99 Participants
|
88 participants
n=107 Participants
|
176 participants
n=206 Participants
|
|
Predicted Location of PORT
MUSC
|
27 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Predicted Location of PORT
Not MUSC
|
61 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after surgerydefined per National Comprehensive Cancer Network Guidelines as the initiation of PORT \> 6 weeks (42 days) following definitive surgery for HNSCC
Outcome measures
| Measure |
NDURE
n=67 Participants
NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model \[HBM\]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.
NDURE: NDURE is a theory-based, multi-level Patient Navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system- (care coordination), interpersonal- (social support), and individual- (Health Belief Model; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, improve cancer care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months).
|
Usual Care
n=78 Participants
UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.
|
|---|---|---|
|
Delay Initiating Postoperative Radiation Therapy (PORT)
|
14 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 18 weeks from surgeryTime, in days, between the date of definitive surgical resection to the initiation of radiation therapy
Outcome measures
| Measure |
NDURE
n=68 Participants
NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model \[HBM\]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.
NDURE: NDURE is a theory-based, multi-level Patient Navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system- (care coordination), interpersonal- (social support), and individual- (Health Belief Model; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, improve cancer care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months).
|
Usual Care
n=78 Participants
UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.
|
|---|---|---|
|
Time Interval Between Surgery and the Start of PORT
|
39 Days
Interval 36.0 to 40.0
|
47 Days
Interval 43.0 to 50.0
|
SECONDARY outcome
Timeframe: 18 weeks from surgerynumber of days from the date of definitive surgery for HNSCC to the date of PORT completion.
Outcome measures
| Measure |
NDURE
n=64 Participants
NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model \[HBM\]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.
NDURE: NDURE is a theory-based, multi-level Patient Navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system- (care coordination), interpersonal- (social support), and individual- (Health Belief Model; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, improve cancer care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months).
|
Usual Care
n=71 Participants
UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.
|
|---|---|---|
|
Treatment Package Time
|
84 Days
Interval 81.0 to 85.0
|
89 Days
Interval 87.0 to 94.0
|
SECONDARY outcome
Timeframe: 6 weeks from surgeryPopulation: reporting PORT delay by racial subgroup
defined per National Comprehensive Cancer Network Guidelines as the initiation of PORT \> 6 weeks (42 days) following definitive surgery for HNSCC between evaluable white and black patients with HNSCC
Outcome measures
| Measure |
NDURE
n=67 Participants
NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model \[HBM\]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.
NDURE: NDURE is a theory-based, multi-level Patient Navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system- (care coordination), interpersonal- (social support), and individual- (Health Belief Model; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, improve cancer care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months).
|
Usual Care
n=78 Participants
UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.
|
|---|---|---|
|
Racial Differences in Delays in Starting PORT
African American
|
3 Participants
|
14 Participants
|
|
Racial Differences in Delays in Starting PORT
White
|
11 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 18 weeks from surgeryPopulation: reporting time to PORT by racial subgroup
Difference between White and Black patients with HNSCC in the number of days between the date of definitive surgical resection to the initiation of radiation therapy.
Outcome measures
| Measure |
NDURE
n=68 Participants
NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model \[HBM\]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.
NDURE: NDURE is a theory-based, multi-level Patient Navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system- (care coordination), interpersonal- (social support), and individual- (Health Belief Model; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, improve cancer care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months).
|
Usual Care
n=78 Participants
UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.
|
|---|---|---|
|
Racial Differences in Time Interval Between Surgery and the Start of PORT
African American
|
38 Days
Interval 36.0 to 46.0
|
55 Days
Interval 43.0 to 60.0
|
|
Racial Differences in Time Interval Between Surgery and the Start of PORT
White
|
39 Days
Interval 35.0 to 40.0
|
45 Days
Interval 42.0 to 49.0
|
SECONDARY outcome
Timeframe: 18 weeks from surgeryPopulation: reporting racial differences in treatment package time
Difference between White and Black patients with HNSCC in the number of days from the date of definitive surgery for HNSCC to the date of PORT completion.
Outcome measures
| Measure |
NDURE
n=64 Participants
NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model \[HBM\]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.
NDURE: NDURE is a theory-based, multi-level Patient Navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system- (care coordination), interpersonal- (social support), and individual- (Health Belief Model; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, improve cancer care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months).
|
Usual Care
n=71 Participants
UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.
|
|---|---|---|
|
Racial Differences in Treatment Package Time
African American
|
83 Days
Interval 78.0 to 89.0
|
93 Days
Interval 85.0 to 105.0
|
|
Racial Differences in Treatment Package Time
White
|
84 Days
Interval 81.0 to 85.0
|
88 Days
Interval 85.0 to 93.0
|
SECONDARY outcome
Timeframe: 3 monthsThe measures assesses the performance (or lack thereof) of a care delivery process (Pre-Surigcal Radiation Consultation) for patients with HNSCC. The measure is evaluated as performed if the patient attends a consultation with a radiation oncologist (at MUSC or elsewhere) prior to surgery to discuss RT in the definitive or adjuvant setting
Outcome measures
| Measure |
NDURE
n=68 Participants
NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model \[HBM\]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.
NDURE: NDURE is a theory-based, multi-level Patient Navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system- (care coordination), interpersonal- (social support), and individual- (Health Belief Model; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, improve cancer care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months).
|
Usual Care
n=78 Participants
UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.
|
|---|---|---|
|
Percent of Patients With Pre-surgical Radiation Consultation
|
47 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 3 monthsThe measures assesses the performance (or lack thereof) of a care delivery process (Pre-Radiation Therapy Dental Extractions) for patients with HNSCC. The measure is evaluated as performed if the patient has extraction of his/her indicated teeth prior to discharge from the index hospitalization for the definitive surgical procedure. Patients who are edentulous are not evaluable for this measure.
Outcome measures
| Measure |
NDURE
n=44 Participants
NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model \[HBM\]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.
NDURE: NDURE is a theory-based, multi-level Patient Navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system- (care coordination), interpersonal- (social support), and individual- (Health Belief Model; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, improve cancer care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months).
|
Usual Care
n=34 Participants
UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.
|
|---|---|---|
|
Percent of Patients With Pre-Radiation Therapy Dental Extractions
|
44 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 3 monthsThe measures assesses the time, in days, from the date of the definitive surgical procedure to the date the referral (or postoperative appointment) is placed to discuss adjuvant therapy with the treating radiation oncologist
Outcome measures
| Measure |
NDURE
n=68 Participants
NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model \[HBM\]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.
NDURE: NDURE is a theory-based, multi-level Patient Navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system- (care coordination), interpersonal- (social support), and individual- (Health Belief Model; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, improve cancer care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months).
|
Usual Care
n=78 Participants
UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.
|
|---|---|---|
|
Time From Surgery to PORT Referral
|
8 Days
Interval 8.0 to 9.0
|
16 Days
Interval 14.0 to 17.0
|
SECONDARY outcome
Timeframe: 3 monthsthe time, in days, from the date of the definitive surgical procedure to the date that the patient attends a postoperative appointment with radiation oncology
Outcome measures
| Measure |
NDURE
n=68 Participants
NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model \[HBM\]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.
NDURE: NDURE is a theory-based, multi-level Patient Navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system- (care coordination), interpersonal- (social support), and individual- (Health Belief Model; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, improve cancer care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months).
|
Usual Care
n=78 Participants
UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.
|
|---|---|---|
|
Time From Surgery to Postoperative Appointment With Radiation Oncology
|
20.0 Days
Interval 19.0 to 21.0
|
24.5 Days
Interval 23.0 to 29.0
|
Adverse Events
NDURE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Evan Graboyes, MD, MPH
Medical University of South Carolina
Phone: 843-792-0719
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place