Study of Survivorship Care Plans and Outcomes in Underserved Breast Cancer Survivors

This study is not yet open for participant recruitment.
Verified June 2012 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Rose C. Maly, MD, MSPH, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01627366
First received: June 4, 2012
Last updated: June 20, 2012
Last verified: June 2012

June 4, 2012
June 20, 2012
August 2012
August 2015   (final data collection date for primary outcome measure)
Provider Adherence Score (PAS) [ Time Frame: One year post-intervention ] [ Designated as safety issue: No ]
Discussion and implementation of recommended breast cancer (BC) survivorship care, including surveillance and the evaluation and management of BC treatment-related symptoms, bone health, weight, vasomotor symptoms, mammography, clinical breast examinations, and depression, as well as discussion of the patient's primary BC-related concern.
Same as current
Complete list of historical versions of study NCT01627366 on ClinicalTrials.gov Archive Site
  • Patient satisfaction [ Time Frame: One year post-invervention ] [ Designated as safety issue: No ]
    Patient satisfaction with survivorship communication and care.
  • Quality of life [ Time Frame: One year post-intervention ] [ Designated as safety issue: No ]
    Health-related quality of life
  • Cost-consequence analysis [ Time Frame: One year post-intervention ] [ Designated as safety issue: No ]
    Assess the immediate cost of the intervention itself, the downstream costs specifically related to health-care utilization from the survivorship care plan recommendations, and the resulting health benefits, in a cost consequence analysis.
Same as current
Not Provided
Not Provided
 
Study of Survivorship Care Plans and Outcomes in Underserved Breast Cancer Survivors
Survivorship Plans and Outcomes in Underserved Breast Cancer Survivors RCT

Improvements in early detection and successful treatment of breast cancer have lead to a steady rise in the number of breast cancer (BC) survivors. With so many individuals living for extended periods after diagnosis, the Institute of Medicine (IOM) recommends the implementation of treatment summaries and survivorship care plans (TSSPs) as a mechanism to improve ongoing clinical and coordination of care, and to address the immediate post-treatment and long-term effects of cancer treatment, including the ongoing psychosocial burden of a cancer diagnosis. The need for TSSPs has also been strongly advocated by the American Society of Clinical Oncology's Quality Oncology Practice Initiative and TSSPs have been included in the recently introduced Comprehensive Cancer Improvement Act (H.R. 1844). This will be one of the first randomized controlled trials to test the efficacy of TSSPs.

The investigators will recruit 500 low income, medically underserved women from two county public hospitals, LAC+USC Medical Center and Harbor-UCLA Medical Center, 12 months after breast cancer diagnosis for participation in a randomized controlled trial (RCT) designed to test the efficacy of TSSPs. The investigators will randomize these women into one of two groups: 1) a control condition of usual medical care and 2) an experimental condition of the control condition + a tailored TSSP + 1 face-to-face nurse counseling session, with all cancer specialists and primary care physicians of record also receiving the TSSP and a cover letter suggesting how they can be clinically utilized.

The investigators specific aims are to assess and compare between experimental and control groups the following primary outcomes at one year post-intervention: 1) discussion and implementation of recommended breast cancer survivorship care, including surveillance and the evaluation and management of BC treatment-related symptoms, 2) patient satisfaction with survivorship communication and care, 3) pertinent aspects of health-related quality of life, and further, to then 4) assess the cost-consequences of the experimental intervention. This study will provide a unique opportunity to assess the efficacy of TSSPs in a low-income, underserved population of BC survivors known to be at high risk for poorer long-term outcomes, including in mental health, quality of life, recurrence and mortality, and will therefore allow us to demonstrate the greatest possible benefit of such an intervention.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Breast Cancer
  • Other: Survivorship Care Plan
    Receipt of a personalized survivorship care plan and an in-person session with a trained nurse to review the contents of the care plan.
    Other Name: Treatment Summary and Survivorship Care Plans
  • Other: Usual care
    Receipt of usual medical care
  • Experimental: Survivorship Care Plan
    Intervention: Other: Survivorship Care Plan
  • No Intervention: Usual care
    Intervention: Other: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
500
September 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female
  • 21 years of age or older
  • English- or Spanish-speaking
  • Diagnosis of ductal carcinoma in situ (DCIS) or Stage I, II, or III BC for the first time
  • 12 months post-diagnosis
  • At least 1 month post-chemotherapy completion

Exclusion Criteria:

  • Previous cancer except non-melanomatous skin cancers or in situ non-breast cancers
  • Pregnant and lactating women
  • Patients receiving parenteral anti-cancer therapy, except trastuzumab
  • Clinically apparent cognitive or psychiatric impairment
  • Participation in another research study
  • Current treatment for another cancer
  • Male
Female
21 Years and older
No
Contact: Jeanette Gibbon, MPH 310-794-6096 jgibbon@mednet.ucla.edu
Contact: Shannon Jason, MSPH 310-794-6096 sjason@mednet.ucla.edu
United States
 
NCT01627366
1R01CA140481
Yes
Rose C. Maly, MD, MSPH, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Rose C Maly, MD, MSPH University of California, Los Angeles
University of California, Los Angeles
June 2012

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