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Clinical Trials/NCT00565110
NCT00565110
Completed
Not Applicable

Effectiveness Study of a Stepped Care Depression Algorithm for Patients With Cancer

University of Southern California1 site in 1 country472 target enrollmentJune 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depression
Sponsor
University of Southern California
Enrollment
472
Locations
1
Primary Endpoint
Reduced Depression Symptoms
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
July 2010
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kathleen R. Ell

Professor

University of Southern California

Eligibility Criteria

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

Outcomes

Primary Outcomes

Reduced Depression Symptoms

Time Frame: 12 months

Number of participants with 50% PHQ-9 score reduction since baseline

Secondary Outcomes

  • Physical Composite Summary Score (PCS) Derived From the 12-item Short Form (SF-12) Health Survey(12 months)

Study Sites (1)

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