Treating Depression Among Low-Income Patients With Cancer (ADAPt-C)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00565110
First received: November 27, 2007
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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
Major Depression
Dysthymia
Behavioral: Alleviating Depression Among Patients with Cancer
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness Study of a Stepped Care Depression Algorithm for Patients With Cancer

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Reduced depression symptoms [ Time Frame: 6, 12 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FACT-G quality of life outcomes social functioning, emotional functioning, functional status [ Time Frame: 6, 12, 18 months ] [ Designated as safety issue: No ]

Enrollment: 472
Study Start Date: July 2004
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: ADAPt-C
Experimental: Treatment Arm
242 patients who received structured collaborative depression care management
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.
Other Name: ADAPt-C

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565110

Locations
United States, California
Los Angeles County+University of Southern California Medical Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Kathleen R Ell, DSW University of Southern California, School of Social Work
  More Information

Publications:
Ell, K., Quon, B., Quinn, D., Dwight-Johnson, M.,Wells, A., Lee, P. J., Xie, B. (2007). Improving Treatment of Depression among Low-Income Patients with Cancer: The Design of the ADAPt-C Study. General Hospital Psychiatry, 29: 223-31.

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00565110     History of Changes
Other Study ID Numbers: ADAPt-C NorrisCCC, NCI RO1CA105269
Study First Received: November 27, 2007
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Dysthymic Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014