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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00565110
First Posted: November 29, 2007
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kathleen R. Ell, University of Southern California
November 27, 2007
November 29, 2007
March 10, 2017
July 24, 2017
July 24, 2017
June 2004
January 2009   (Final data collection date for primary outcome measure)
Reduced Depression Symptoms [ Time Frame: 12 months ]
Number of participants with 50% PHQ-9 score reduction since baseline
Reduced Depression Symptoms [ Time Frame: 6, 12 18 months ]
Complete list of historical versions of study NCT00565110 on ClinicalTrials.gov Archive Site
Physical Composite Summary Score (PCS) Derived From the 12-item Short Form (SF-12) Health Survey [ Time Frame: 12 months ]
The SF-12 measures 8 health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. PCS is a summary score measuring physical health derived by summing responses across scale items and then transforming to a 0-100 scale (higher scores indicate better health).
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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Major Depression
  • Dysthymia
Behavioral: 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.
  • No Intervention: 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.
  • Experimental: 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.
    Intervention: Behavioral: ADAPt-C intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
472
July 2010
January 2009   (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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00565110
USCIRB-HS-10-00466
R01CA105269 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description:

National Cancer Institute, "Project ADAPT-C" selected for Research-Tested Interventions NCI Program 2014, http://rtips.cancer.gov/rtips/programDetails.do?programId=3551008. https://researchtoreality.cancer.gov/featured-r2r-partners/kathleen-ell-dsw

1. ADAPt-C randomized clinical trial selected by the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS Consortia) led by the Netherlands

Kathleen R. Ell, 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
April 2017

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