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

November 27, 2007
January 25, 2013
July 2004
December 2014   (final data collection date for primary outcome measure)
Reduced depression symptoms [ Time Frame: 6, 12 18 months ] [ Designated as safety issue: No ]
Reduced depression symptoms [ Time Frame: 6, 12 18 months ]
Complete list of historical versions of study NCT00565110 on ClinicalTrials.gov Archive Site
FACT-G quality of life outcomes social functioning, emotional functioning, functional status [ Time Frame: 6, 12, 18 months ] [ Designated as safety issue: No ]
FACT-G quality of life outcomes social functioning, emotional functioning, functional status [ Time Frame: 6, 12, 18 months ]
Not Provided
Not Provided
 
Treating Depression Among Low-Income Patients With Cancer
Effectiveness Study of a Stepped Care Depression Algorithm for Patients With Cancer

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Major Depression
  • Dysthymia
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
  • Usual Care
    Intervention: Behavioral: Alleviating Depression Among Patients with Cancer
  • Experimental: Treatment Arm
    242 patients who received structured collaborative depression care management
    Intervention: Behavioral: Alleviating Depression Among Patients with Cancer
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
472
December 2015
December 2014   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00565110
ADAPt-C NorrisCCC, NCI RO1CA105269
Yes
University of Southern California
University of Southern California
National Cancer Institute (NCI)
Principal Investigator: Kathleen R Ell, DSW University of Southern California, School of Social Work
University of Southern California
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP