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Sponsors and Collaborators: |
Norris Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | Norris Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00565110 |
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 |
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Major Depression Dysthymia |
Behavioral: Alleviating Depression Among Patients with Cancer |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Effectiveness Study of a Stepped Care Depression Algorithm for Patients With Cancer |
Enrollment: | 472 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | February 2009 |
Arms | Assigned Interventions |
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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.
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Treatment Arm: Experimental
242 patients who received structured collaborative depression care management
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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.
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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.
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
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 |
Study ID Numbers: | ADAPt-C NorrisCCC, NCI RO1CA105269 |
Study First Received: | November 27, 2007 |
Last Updated: | November 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00565110 |
Health Authority: | United States: Institutional Review Board |
Depression Mental Disorders Mood Disorders Dysthymic Disorder |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |