Treating Depression Among Low-Income Patients With Cancer (ADAPt-C)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depression Dysthymia |
Behavioral: Alleviating Depression Among Patients with Cancer |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effectiveness Study of a Stepped Care Depression Algorithm for Patients With Cancer |
- Reduced depression symptoms [ Time Frame: 6, 12 18 months ] [ Designated as safety issue: No ]
- FACT-G quality of life outcomes social functioning, emotional functioning, functional status [ Time Frame: 6, 12, 18 months ] [ Designated as safety issue: No ]
| Enrollment: | 472 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Usual Care |
Behavioral: Alleviating Depression Among Patients with Cancer
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 consultantation 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.
Other Name: ADAPt-C
|
|
Experimental: Treatment Arm
242 patients who received structured collaborative depression care management
|
Behavioral: Alleviating Depression Among Patients with Cancer
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 consultantation 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.
Other Name: ADAPt-C
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, California | |
| Los Angeles County+University of Southern California Medical Center | |
| Los Angeles, California, United States, 90033 | |
| Principal Investigator: | Kathleen R Ell, DSW | University of Southern California, School of Social Work |
More Information
Publications:
| Responsible Party: | USC/Norris Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00565110 History of Changes |
| Other Study ID Numbers: | ADAPt-C NorrisCCC, NCI RO1CA105269 |
| Study First Received: | November 27, 2007 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Dysthymic Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013