Dysthymia, Major Depression
Conditions
Brief summary
The ADAPt-C collaborative depression care model is designed to: improve depression symptom reduction in the intervention group over the modestly enhanced usual care group of low-income, predominantly Hispanic, patients with cancer who are receiving care in an urban public sector care system; and to improve quality of life outcomes among intervention patients over enhanced usual care.
Detailed description
This controlled trial has tested the effectiveness of a socio-culturally tailored depression care program that includes a patient-centered approach to antidepressant medication management or structured psychotherapy (Problem Solving Treatment (PST)), patient/family depression education, treatment maintenance and relapse prevention counseling. Intervention enhancements include: depression care management based on a stepped care depression treatment algorithm; extension of the oncology care management team with a master's degreed social worker, who acts as Cancer Depression Clinical Specialist (CDCS) and provides PST, treatment follow-up and feedback to the oncologist, and who facilitates patient-provider communication and health system and community resources navigation; a psychiatric consultant, who provides supervision of the CDCS and consultation and antidepressant medication prescription for individual patients; and a didactic for oncologists on depression management. Cultural sensitivity and competency enhancements include: patient choice of first line treatment (antidepressant medication/PST) and degree of family participation in their depression care; PST tailored for language and literacy of patients with cancer; bilingual, bicultural CDCS; Spanish educational materials; and communication facilitation. Enhanced Usual Care (EUC) patients will receive the care and services routinely provided patients with cancer plus an educational/resource pamphlet for patients and for family members(on depression and cancer, depression treatment, talking with your doctor about your depression, and medical center and community mental health care resources). With patient consent, the oncologist is informed if EUC patients screen positive for major depression/dysthymia.
Interventions
BEHAVIORALADAPt-C intervention
Experimental Arm 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.
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- 90 days post cancer diagnosis receiving acute cancer treatment or active follow-up
Exclusion criteria
\- patients with advanced cancer or another medical condition that limited life expectancy to less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduced Depression Symptoms | 12 months | Number of participants with 50% PHQ-9 score reduction since baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Composite Summary Score (PCS) Derived From the 12-item Short Form (SF-12) Health Survey | 12 months | The 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 230 |
| 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. | 242 |
| Total | 472 |
Baseline characteristics
| Characteristic | Enhanced Usual Care | ADAPt-C Intervention | Total |
|---|---|---|---|
| Age, Continuous | 49.77 years STANDARD_DEVIATION 12.93 | 47.59 years STANDARD_DEVIATION 12.88 | 48.65 years STANDARD_DEVIATION 12.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 196 Participants | 219 Participants | 415 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 23 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 230 participants | 242 participants | 472 participants |
| Sex: Female, Male Female | 197 Participants | 202 Participants | 399 Participants |
| Sex: Female, Male Male | 33 Participants | 40 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 54 / 230 | 45 / 242 |
| other Total, other adverse events | 0 / 230 | 0 / 242 |
| serious Total, serious adverse events | 55 / 230 | 47 / 242 |
Outcome results
Primary
Reduced Depression Symptoms
Number of participants with 50% PHQ-9 score reduction since baseline
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Usual Care | Reduced Depression Symptoms | 57 Participants |
| ADAPt-C Intervention | Reduced Depression Symptoms | 91 Participants |
Secondary
Physical Composite Summary Score (PCS) Derived From the 12-item Short Form (SF-12) Health Survey
The 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).
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Usual Care | 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 |
| ADAPt-C Intervention | Physical Composite Summary Score (PCS) Derived From the 12-item Short Form (SF-12) Health Survey | 41.48 units on a scale | Standard Error 0.84 |