Clinical trial NCT00565110: Treating Depression Among Low-Income Patients With Cancer
Official title: Effectiveness Study of a Stepped Care Depression Algorithm for Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Dysthymia
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-11-29
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduced Depression Symptoms
timeFrame: 12 months
Secondary outcomes:
measure: Physical Composite Summary Score (PCS) Derived From the 12-item Short Form (SF-12) Health Survey
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County+University of Southern California Medical Center
state: California
Study officials:
affiliation: University of Southern California, School of Social Work
name: Kathleen R Ell, DSW
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ell K, Quon B, Quinn DI, Dwight-Johnson M, Wells A, Lee PJ, Xie B. Improving treatment of depression among low-income patients with cancer: the design of the ADAPt-C study. Gen Hosp Psychiatry. 2007 May-Jun;29(3):223-31. doi: 10.1016/j.genhosppsych.2007.01.005.