Trial Outcomes & Findings for Treating Depression Among Low-Income Patients With Cancer (NCT NCT00565110)
NCT ID: NCT00565110
Last Updated: 2017-07-24
Results Overview
Number of participants with 50% PHQ-9 score reduction since baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
472 participants
Primary outcome timeframe
12 months
Results posted on
2017-07-24
Participant Flow
Participant milestones
| Measure |
Enhanced Usual Care
EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
|
ADAPt-C Intervention
Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
|
|---|---|---|
|
Overall Study
STARTED
|
230
|
242
|
|
Overall Study
12-Month
|
114
|
144
|
|
Overall Study
COMPLETED
|
99
|
111
|
|
Overall Study
NOT COMPLETED
|
131
|
131
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Depression Among Low-Income Patients With Cancer
Baseline characteristics by cohort
| Measure |
Enhanced Usual Care
n=230 Participants
EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
|
ADAPt-C Intervention
n=242 Participants
Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
|
Total
n=472 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.77 years
STANDARD_DEVIATION 12.93 • n=5 Participants
|
47.59 years
STANDARD_DEVIATION 12.88 • n=7 Participants
|
48.65 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
399 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
196 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
415 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
230 participants
n=5 Participants
|
242 participants
n=7 Participants
|
472 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber of participants with 50% PHQ-9 score reduction since baseline
Outcome measures
| Measure |
Enhanced Usual Care
n=114 Participants
EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
|
ADAPt-C Intervention
n=144 Participants
Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
|
|---|---|---|
|
Reduced Depression Symptoms
|
57 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: 12 monthsThe SF-12 measures 8 health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. PCS is a summary score measuring physical health derived by summing responses across scale items and then transforming to a 0-100 scale (higher scores indicate better health).
Outcome measures
| Measure |
Enhanced Usual Care
n=114 Participants
EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
|
ADAPt-C Intervention
n=144 Participants
Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
|
|---|---|---|
|
Physical Composite Summary Score (PCS) Derived From the 12-item Short Form (SF-12) Health Survey
|
38.68 units on a scale
Standard Error 0.91
|
41.48 units on a scale
Standard Error 0.84
|
Adverse Events
Enhanced Usual Care
Serious events: 55 serious events
Other events: 0 other events
Deaths: 54 deaths
ADAPt-C Intervention
Serious events: 47 serious events
Other events: 0 other events
Deaths: 45 deaths
Serious adverse events
| Measure |
Enhanced Usual Care
n=230 participants at risk
EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer. In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients). With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression. Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
|
ADAPt-C Intervention
n=242 participants at risk
Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management. Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
23.5%
54/230 • Number of events 54 • 2 years
The study intervention provided only behavioral sessions, thus no serious and other non-serious adverse events were collected or assessed systematically. However, we documented event information revealed by family member of participants, if any.
|
18.6%
45/242 • Number of events 45 • 2 years
The study intervention provided only behavioral sessions, thus no serious and other non-serious adverse events were collected or assessed systematically. However, we documented event information revealed by family member of participants, if any.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
In hospice or palliative care
|
0.43%
1/230 • Number of events 1 • 2 years
The study intervention provided only behavioral sessions, thus no serious and other non-serious adverse events were collected or assessed systematically. However, we documented event information revealed by family member of participants, if any.
|
0.83%
2/242 • Number of events 2 • 2 years
The study intervention provided only behavioral sessions, thus no serious and other non-serious adverse events were collected or assessed systematically. However, we documented event information revealed by family member of participants, if any.
|
Other adverse events
Adverse event data not reported
Additional Information
Kathleen Ell, DSW, Principle Investigator
USC Suzanne Dworak-Peck School of Social Work
Phone: 760-399-0263
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place