Trial Outcomes & Findings for Implementing Systematic Distress Screening in Breast Cancer (NCT NCT02941614)
NCT ID: NCT02941614
Last Updated: 2020-07-07
Results Overview
\# of newly diagnosed breast cancer patients offered and screened with the Patient Health Questionnaire 9 at their initial consult
Recruitment status
COMPLETED
Target enrollment
1436 participants
Primary outcome timeframe
Patients assessed during initial consult - e.g. 1 day during 60 min consult
Results posted on
2020-07-07
Participant Flow
Participant milestones
| Measure |
Distress Screening
Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).
Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ-9) will be administered to newly diagnosed breast cancer patients in the Distress Screening arm.
|
No Screening
Newly diagnosed breast cancer patients will experience usual care, which may include PHQ-9 screening.
|
|---|---|---|
|
Overall Study
STARTED
|
744
|
692
|
|
Overall Study
COMPLETED
|
603
|
446
|
|
Overall Study
NOT COMPLETED
|
141
|
246
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementing Systematic Distress Screening in Breast Cancer
Baseline characteristics by cohort
| Measure |
Distress Screening
n=744 Participants
Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).
Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ), will be administered to newly diagnosed breast cancer patients in the Distress Screening arm. The PHQ starts with a 2-item screen, and branches to the full screening instrument as needed.
|
No Screening
n=692 Participants
Newly diagnosed breast cancer patients will experience usual care.
|
Total
n=1436 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
|
425 Participants
n=99 Participants
|
381 Participants
n=107 Participants
|
806 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
319 Participants
n=99 Participants
|
311 Participants
n=107 Participants
|
630 Participants
n=206 Participants
|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 12.35 • n=99 Participants
|
62 years
STANDARD_DEVIATION 13.34 • n=107 Participants
|
61.5 years
STANDARD_DEVIATION 12.84 • n=206 Participants
|
|
Sex: Female, Male
Female
|
740 Participants
n=99 Participants
|
689 Participants
n=107 Participants
|
1429 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
204 Participants
n=99 Participants
|
172 Participants
n=107 Participants
|
376 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
483 Participants
n=99 Participants
|
476 Participants
n=107 Participants
|
959 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
57 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
151 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
264 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
106 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
249 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
401 Participants
n=99 Participants
|
370 Participants
n=107 Participants
|
771 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
73 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
744 Participants
n=99 Participants
|
692 Participants
n=107 Participants
|
1436 Participants
n=206 Participants
|
|
Charlson Comorbidity Score
|
2.2 units on a scale
STANDARD_DEVIATION 2.75 • n=99 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 2.62 • n=107 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 2.69 • n=206 Participants
|
|
Cancer Stage
Stage 0
|
32 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Cancer Stage
Stage I
|
145 Participants
n=99 Participants
|
106 Participants
n=107 Participants
|
251 Participants
n=206 Participants
|
|
Cancer Stage
Stage II
|
236 Participants
n=99 Participants
|
234 Participants
n=107 Participants
|
470 Participants
n=206 Participants
|
|
Cancer Stage
Stage III
|
236 Participants
n=99 Participants
|
219 Participants
n=107 Participants
|
455 Participants
n=206 Participants
|
|
Cancer Stage
Stage IV
|
58 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
|
Cancer Stage
Missing
|
37 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Patients assessed during initial consult - e.g. 1 day during 60 min consult\# of newly diagnosed breast cancer patients offered and screened with the Patient Health Questionnaire 9 at their initial consult
Outcome measures
| Measure |
Distress Screening
n=744 Participants
Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).
Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ-9) will be administered to newly diagnosed breast cancer patients in the Distress Screening arm.
|
No Screening
n=692 Participants
Newly diagnosed breast cancer patients will experience usual care, which may include PHQ-9 screening.
|
|---|---|---|
|
Number of Participants Offered and Screened for Distress
|
596 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Patients assessed during initial consult - e.g. 1 day during 60 min consultPopulation: Patients who completed PHQ-9 screening in Oncology with med/high score
For patients who had screening done in Oncology, appropriate action for those with a medium/high PHQ-9 is a referral to social work, psychiatry, depression care management.
Outcome measures
| Measure |
Distress Screening
n=63 Participants
Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).
Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ-9) will be administered to newly diagnosed breast cancer patients in the Distress Screening arm.
|
No Screening
n=1 Participants
Newly diagnosed breast cancer patients will experience usual care, which may include PHQ-9 screening.
|
|---|---|---|
|
Number of Participants Offered an Appropriate Referral
|
51 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patients who completed at least one survey item in Fact-B at the 3, 6 and/or 12 month survey. The number of participants analyzed for the total scores and sub-scale scores at 3-, 6- and 12 months varies, because not all patients responded to all surveys or answered all of the questions in a survey.
Self-reported for physical well-being; social family well-being; emotional well-being; functional well-being; and additional concerns over the past 7 days; scale: 0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much; responses indicate symptoms/concerns in the past 7 days. The higher the score, the better the outcome. To derive a FACT-B total score, score range 0-148. The subscales include: (1) Physical Well-Being, score range 0-28; (2) Social/Family Well-Being, score range 0-28; (3) Emotional Well-Being, score range 0-24; (4) Functional well-being, score range 0-28; (5) Breast Cancer Subscale, score range 0-40.
Outcome measures
| Measure |
Distress Screening
n=224 Participants
Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).
Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ-9) will be administered to newly diagnosed breast cancer patients in the Distress Screening arm.
|
No Screening
n=238 Participants
Newly diagnosed breast cancer patients will experience usual care, which may include PHQ-9 screening.
|
|---|---|---|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 6 month Social/Family Well-Being Subscale
|
20.5 units on a scale
Standard Deviation 6.2
|
21.3 units on a scale
Standard Deviation 5.3
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 3-month Total Score
|
104.5 units on a scale
Standard Deviation 22.1
|
104.6 units on a scale
Standard Deviation 23.0
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 3-month Physical Well-Being Subscale
|
20.8 units on a scale
Standard Deviation 6.2
|
20.5 units on a scale
Standard Deviation 6.5
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 3 month Social/Family Well-Being Subscale
|
21.2 units on a scale
Standard Deviation 6.2
|
21.4 units on a scale
Standard Deviation 5.8
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 3 month Emotional Well-Being Subscale
|
18.3 units on a scale
Standard Deviation 4.3
|
18.3 units on a scale
Standard Deviation 4.4
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 3-month Functional Well-Being Subscale
|
18.3 units on a scale
Standard Deviation 6.7
|
18.1 units on a scale
Standard Deviation 6.6
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 3-month Breast Cancer Subscale
|
26.5 units on a scale
Standard Deviation 6.8
|
26.4 units on a scale
Standard Deviation 6.9
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 6 month Total Score
|
108.1 units on a scale
Standard Deviation 22.3
|
105.3 units on a scale
Standard Deviation 21.9
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 6 month Physical Well-Being Subscale
|
22.3 units on a scale
Standard Deviation 5.9
|
21.9 units on a scale
Standard Deviation 5.4
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 6 month Emotional Well-Being Subscale
|
18.5 units on a scale
Standard Deviation 4.3
|
18.0 units on a scale
Standard Deviation 4.4
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 6 month Functional Well-Being Subscale
|
19.2 units on a scale
Standard Deviation 6.2
|
18.5 units on a scale
Standard Deviation 6.4
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 6 month Breast Cancer Subscale
|
27.0 units on a scale
Standard Deviation 6.9
|
25.8 units on a scale
Standard Deviation 7.5
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 12 month Total Score
|
109.1 units on a scale
Standard Deviation 22.9
|
108.3 units on a scale
Standard Deviation 22.4
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 12 month Physical Well-Being Subscale
|
22.1 units on a scale
Standard Deviation 5.6
|
22.3 units on a scale
Standard Deviation 5.5
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 12 month Social/Family Well-Being Subscale
|
20.7 units on a scale
Standard Deviation 6.1
|
20.9 units on a scale
Standard Deviation 6.0
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 12 month Emotional Subscale
|
18.8 units on a scale
Standard Deviation 3.9
|
18.6 units on a scale
Standard Deviation 4.4
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 12 month Functional Well-Being
|
19.9 units on a scale
Standard Deviation 6.3
|
19.9 units on a scale
Standard Deviation 5.9
|
|
Functional Assessment of Cancer Therapy, Breast Cancer (FACT-B)
Fact-B 12 month Breast Cancer Subscale
|
27.1 units on a scale
Standard Deviation 6.9
|
26.9 units on a scale
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Number of participants analyzed varies across rows for 3-, 6- and 12-month surveys because not all patients completed all surveys and/or answered all questions in a survey.
Self-reported measure of physical symptoms in the past 4 weeks; scale: 0=not at all; 1=slightly; 2=moderately; 3=quite a bit; 4=extremely. Higher scores indicate greater symptom burden. Sub-scales include Hot Flashes, Nausea, Bladder Control, Vaginal Problems, Musculoskelatal Pain, Cognitive Problems, Weight Problems, and Arm Problems.
Outcome measures
| Measure |
Distress Screening
n=221 Participants
Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).
Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ-9) will be administered to newly diagnosed breast cancer patients in the Distress Screening arm.
|
No Screening
n=235 Participants
Newly diagnosed breast cancer patients will experience usual care, which may include PHQ-9 screening.
|
|---|---|---|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 3 Month Total Score
|
0.9 units on a scale
Standard Deviation 0.6
|
1.0 units on a scale
Standard Deviation 0.7
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 3 month Hot Flashes Sub-Scale
|
1.2 units on a scale
Standard Deviation 1.1
|
1.2 units on a scale
Standard Deviation 1.2
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 3 month Nausea Sub-Scale
|
0.4 units on a scale
Standard Deviation 0.7
|
0.5 units on a scale
Standard Deviation 0.8
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Suvey 3 month Bladder Control Sub-Scale
|
0.6 units on a scale
Standard Deviation 0.9
|
0.7 units on a scale
Standard Deviation 1.0
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 3 month Vaginal/Sex Problems Sub-Scale
|
0.6 units on a scale
Standard Deviation 1.0
|
0.8 units on a scale
Standard Deviation 1.1
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 3 month Musculoskeletal Pain Sub-Scale
|
1.5 units on a scale
Standard Deviation 1.1
|
1.5 units on a scale
Standard Deviation 1.1
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Suvey 3 month Cognitive Problems Sub-Scale
|
1.2 units on a scale
Standard Deviation 1.0
|
1.2 units on a scale
Standard Deviation 1.1
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 3 month Weight Problems Sub-Scale
|
1.1 units on a scale
Standard Deviation 1.0
|
1.2 units on a scale
Standard Deviation 1.2
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 3 month Arm Problems Sub-Scale
|
0.6 units on a scale
Standard Deviation 0.8
|
0.5 units on a scale
Standard Deviation 0.9
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Suvey 6 month Total Score
|
0.9 units on a scale
Standard Deviation 0.7
|
0.9 units on a scale
Standard Deviation 0.6
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 6 month Hot Flashes Sub-Scale
|
1.2 units on a scale
Standard Deviation 1.1
|
1.1 units on a scale
Standard Deviation 1.2
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 6 month Nausea Sub-Scale
|
0.2 units on a scale
Standard Deviation 0.4
|
0.3 units on a scale
Standard Deviation 0.5
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 6 month Bladder Control Sub-Scale
|
0.7 units on a scale
Standard Deviation 1.0
|
0.6 units on a scale
Standard Deviation 0.9
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 6 month Vaginal/Sex Problems Sub-Scale
|
0.7 units on a scale
Standard Deviation 1.0
|
0.8 units on a scale
Standard Deviation 1.1
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 6 month Musculoskeletal Pain Sub-Scale
|
1.5 units on a scale
Standard Deviation 1.1
|
1.4 units on a scale
Standard Deviation 1.2
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 6 month Cognitive Problems Sub-Scale
|
1.0 units on a scale
Standard Deviation 1.0
|
1.0 units on a scale
Standard Deviation 1.0
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 6 month Weight Problems Sub-Scale
|
1.1 units on a scale
Standard Deviation 1.1
|
1.2 units on a scale
Standard Deviation 1.1
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 6 month Arm Problems Sub-Scale
|
0.5 units on a scale
Standard Deviation 0.7
|
0.5 units on a scale
Standard Deviation 0.8
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 12 month Total Score
|
0.9 units on a scale
Standard Deviation 0.6
|
0.9 units on a scale
Standard Deviation 0.6
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 12 month Hot Flashes Sub-Scale
|
1.1 units on a scale
Standard Deviation 1.1
|
1.0 units on a scale
Standard Deviation 1.1
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 12 month Nausea Sub-Scale
|
0.2 units on a scale
Standard Deviation 0.4
|
0.3 units on a scale
Standard Deviation 0.6
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 12 month Bladder Control Sub-Scale
|
0.7 units on a scale
Standard Deviation 0.9
|
0.7 units on a scale
Standard Deviation 0.9
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 12 month Vaginal/Sex Problem Sub-Scale
|
0.8 units on a scale
Standard Deviation 1.1
|
0.9 units on a scale
Standard Deviation 1.2
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 12 month Musculoskeletal Pain Sub-Scal
|
1.7 units on a scale
Standard Deviation 1.1
|
1.5 units on a scale
Standard Deviation 1.1
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 12 month Cognitive Problems Sub-Scale
|
1.0 units on a scale
Standard Deviation 1.0
|
1.1 units on a scale
Standard Deviation 1.0
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 12 month Weight Problems Sub-Scale
|
1.0 units on a scale
Standard Deviation 1.1
|
1.1 units on a scale
Standard Deviation 1.0
|
|
Breast Cancer Prevention Trial (BCPT) Symptom Checklist
BCPT Survey 12 month Arm Problems Sub-Scale
|
0.5 units on a scale
Standard Deviation 0.8
|
0.5 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 18 monthsBetween group comparison of number of visits to oncology. Restricted to patients with at least 100 days of follow-up. Covariates included in multivariable models were age, Charlson's comorbidity index, race/ethnicity, marital status, and cancer stage.
Outcome measures
| Measure |
Distress Screening
n=730 Participants
Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).
Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ-9) will be administered to newly diagnosed breast cancer patients in the Distress Screening arm.
|
No Screening
n=683 Participants
Newly diagnosed breast cancer patients will experience usual care, which may include PHQ-9 screening.
|
|---|---|---|
|
Number of Patients With Oncology Visit
|
728 Participants
|
683 Participants
|
SECONDARY outcome
Timeframe: 18 monthsBetween group comparison of number of visits to primary care. Restricted to patients with at least 100 days of follow-up. Covariates included in multivariable models were age, Charlson's comorbidity index, race/ethnicity, marital status, and cancer stage.
Outcome measures
| Measure |
Distress Screening
n=730 Participants
Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).
Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ-9) will be administered to newly diagnosed breast cancer patients in the Distress Screening arm.
|
No Screening
n=683 Participants
Newly diagnosed breast cancer patients will experience usual care, which may include PHQ-9 screening.
|
|---|---|---|
|
Number of Patients With Primary Care Visit
|
648 Participants
|
616 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsBetween group comparison of number of visits with behavioral health providers. Restricted to patients with at least 100 days of follow-up. Covariates included in multivariable models were age, Charlson's comorbidity index, race/ethnicity, marital status, and cancer stage.
Outcome measures
| Measure |
Distress Screening
n=730 Participants
Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).
Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ-9) will be administered to newly diagnosed breast cancer patients in the Distress Screening arm.
|
No Screening
n=683 Participants
Newly diagnosed breast cancer patients will experience usual care, which may include PHQ-9 screening.
|
|---|---|---|
|
Number of Participants Utilizing Behavioral Health Services
|
287 Participants
|
247 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 monthsBetween group comparison of number of visits to emergency and urgent care services. Restricted to patients with at least 100 days of follow-up. Covariates included in multivariable models were age, Charlson's comorbidity index, race/ethnicity, marital status, and cancer stage.
Outcome measures
| Measure |
Distress Screening
n=730 Participants
Newly diagnosed breast cancer patients will be offered a brief distress screening questionnaire, the Patient Health Questionnaire (PHQ), around the time of their breast cancer diagnosis and again at subsequent transitions in care as appropriate (e.g., the initiation of chemotherapy).
Distress screening: A brief depression and anxiety screening instrument, the Patient Health Questionnaire (PHQ-9) will be administered to newly diagnosed breast cancer patients in the Distress Screening arm.
|
No Screening
n=683 Participants
Newly diagnosed breast cancer patients will experience usual care, which may include PHQ-9 screening.
|
|---|---|---|
|
Number of Participants Utilizing Emergency and Urgent Care Services
ED Visits
|
248 Participants
|
213 Participants
|
|
Number of Participants Utilizing Emergency and Urgent Care Services
Urgent Care Visits
|
269 Participants
|
279 Participants
|
Adverse Events
Distress Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 25 deaths
No Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 16 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Erin Hahn
Kaiser Permanente Southern California Department of Research and Evaluation
Phone: 626-564-3505
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place