Treating Depression Among Low-Income Patients With Cancer (ADAPt-C)
| Tracking Information | |||||
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| First Received Date ICMJE | November 27, 2007 | ||||
| Last Updated Date | January 25, 2013 | ||||
| Start Date ICMJE | July 2004 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Reduced depression symptoms [ Time Frame: 6, 12 18 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Reduced depression symptoms [ Time Frame: 6, 12 18 months ] | ||||
| Change History | Complete list of historical versions of study NCT00565110 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
FACT-G quality of life outcomes social functioning, emotional functioning, functional status [ Time Frame: 6, 12, 18 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
FACT-G quality of life outcomes social functioning, emotional functioning, functional status [ Time Frame: 6, 12, 18 months ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treating Depression Among Low-Income Patients With Cancer | ||||
| Official Title ICMJE | Effectiveness Study of a Stepped Care Depression Algorithm for Patients With Cancer | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 472 | ||||
| Estimated Completion Date | December 2015 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00565110 | ||||
| Other Study ID Numbers ICMJE | ADAPt-C NorrisCCC, NCI RO1CA105269 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | USC/Norris Comprehensive Cancer Center | ||||
| Study Sponsor ICMJE | USC/Norris Comprehensive Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | USC/Norris Comprehensive Cancer Center | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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