Treating Depression Among Low-Income Patients With Cancer

NCT00565110 | Completed Results DMC

• 2 other identifiers: USCIRB-HS-10-00466R01CA105269
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression; Dysthymia

Outcome Measures

Primary Outcomes (1)

• Reduced Depression Symptoms

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

  12 months

Secondary Outcomes (1)

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

  12 months

Study Arms (2)

Enhanced Usual Care

NO INTERVENTION

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.

ADAPt-C intervention

EXPERIMENTAL

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.

Behavioral: ADAPt-C intervention

Interventions

ADAPt-C intervention 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.

ADAPt-C intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 90 days post cancer diagnosis receiving acute cancer treatment or active follow-up

You may not qualify if:

• \- patients with advanced cancer or another medical condition that limited life expectancy to less than 6 months

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Los Angeles County+University of Southern California Medical Center

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• 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.

  PMID: 17484939 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Dysthymic Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Kathleen Ell, DSW, Principle Investigator
• Organization: USC Suzanne Dworak-Peck School of Social Work

ell@usc.edu

760-399-0263

Study Officials

• Kathleen R Ell, DSW

  University of Southern California, School of Social Work

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 29, 2007
• Study Start: June 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: July 1, 2010
• Last Updated: July 24, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)