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

Primary Purpose

Major Depression, Dysthymia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADAPt-C intervention
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Los Angeles County+University of Southern California Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Enhanced Usual Care

ADAPt-C intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 27, 2007
Last Updated
April 21, 2017
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00565110
Brief Title
Treating Depression Among Low-Income Patients With Cancer
Acronym
ADAPt-C
Official Title
Effectiveness Study of a Stepped Care Depression Algorithm for Patients With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2004 (Actual)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Dysthymia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
472 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
ADAPt-C intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
ADAPt-C intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduced Depression Symptoms
Description
Number of participants with 50% PHQ-9 score reduction since baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Physical Composite Summary Score (PCS) Derived From the 12-item Short Form (SF-12) Health Survey
Description
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).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen R Ell, DSW
Organizational Affiliation
University of Southern California, School of Social Work
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles County+University of Southern California Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
17484939
Citation
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.
Results Reference
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Treating Depression Among Low-Income Patients With Cancer

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