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

NCT01627366 | Completed DMC

• 1 other identifier: 1R01CA140481
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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, 10-24 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Provider Adherence Score (PAS)

  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.

  One year post-intervention

Secondary Outcomes (3)

• Patient satisfaction

  One year post-intervention

• Quality of life

  One year post-intervention

• Cost-consequence analysis

  One year post-intervention

Study Arms (2)

Survivorship Care Plan

EXPERIMENTAL

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: Survivorship Care Plan

Usual care

NO INTERVENTION

Receipt of usual medical care.

Interventions

Survivorship Care Plan OTHER

Receipt of a personalized survivorship care plan and an in-person session with a trained nurse to review the contents of the care plan.

Also known as: Treatment Summary and Survivorship Care Plans

Survivorship Care Plan

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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
• months post-diagnosis
• At least 1 month post-chemotherapy completion

You may not qualify if:

• 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
• Residing outside of Los Angeles County
• Too ill to participate

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rose C Maly, MD, MSPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 25, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 1, 2016

Record last verified: 2015-11

Locations

US (1)