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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
Results First Submitted: March 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Major Depression
Dysthymia
Intervention: Behavioral: ADAPt-C intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Enhanced Usual Care   ADAPt-C Intervention
STARTED   230   242 
12-Month   114   144 
COMPLETED   99   111 
NOT COMPLETED   131   131 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
   Enhanced Usual Care   ADAPt-C Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 230   242   472 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.77  (12.93)   47.59  (12.88)   48.65  (12.94) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      197  85.7%      202  83.5%      399  84.5% 
Male      33  14.3%      40  16.5%      73  15.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      196  85.2%      219  90.5%      415  87.9% 
Not Hispanic or Latino      34  14.8%      23   9.5%      57  12.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   230   242   472 


  Outcome Measures
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1.  Primary:   Reduced Depression Symptoms   [ Time Frame: 12 months ]

2.  Secondary:   Physical Composite Summary Score (PCS) Derived From the 12-item Short Form (SF-12) Health Survey   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kathleen Ell, DSW, Principle Investigator
Organization: USC Suzanne Dworak-Peck School of Social Work
phone: 760-399-0263
e-mail: ell@usc.edu


Publications:

Responsible Party: Kathleen R. Ell, University of Southern California
ClinicalTrials.gov Identifier: NCT00565110     History of Changes
Other Study ID Numbers: USCIRB-HS-10-00466
R01CA105269 ( U.S. NIH Grant/Contract )
First Submitted: November 27, 2007
First Posted: November 29, 2007
Results First Submitted: March 10, 2017
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017