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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Breast Cancer
Other: Survivorship Care Plan
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Survivorship Plans and Outcomes in Underserved Breast Cancer Survivors RCT

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 500
Study Start Date: August 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Survivorship Care Plan 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
No Intervention: Usual care Other: Usual care
Receipt of usual medical care

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627366

Contacts
Contact: Jeanette Gibbon, MPH 310-794-6096 jgibbon@mednet.ucla.edu
Contact: Shannon Jason, MSPH 310-794-6096 sjason@mednet.ucla.edu

Locations
United States, California
UCLA Not yet recruiting
Los Angeles, California, United States, 90024
Contact: Jeanette Gibbon, MPH         
Principal Investigator: Rose C Maly, MD, MSPH         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Rose C Maly, MD, MSPH University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Rose C. Maly, MD, MSPH, Associate Professor of Family Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01627366     History of Changes
Other Study ID Numbers: 1R01CA140481
Study First Received: June 4, 2012
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014