Treating Depression Among Low-Income Patients With Cancer

NCT ID: NCT00565110

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 472 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2010-07-31

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.

Conditions

Major Depression; Dysthymia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

ADAPt-C intervention

Intervention Type: BEHAVIORAL

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.

Interventions

ADAPt-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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Kathleen R. Ell

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen R Ell, DSW

Role: PRINCIPAL_INVESTIGATOR

University of Southern California, School of Social Work

Locations

Los Angeles County+University of Southern California Medical Center

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17484939 (View on PubMed)

Other Identifiers

R01CA105269

Identifier Type: NIH

Identifier Source: secondary_id

View Link

USCIRB-HS-10-00466

Identifier Type: -

Identifier Source: org_study_id