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Survivorship Care Planning in Improving the Quality of Life in Breast Cancer Survivors

Sponsor
City of Hope Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01824745
Collaborator
National Cancer Institute (NCI) (NIH)
100
Enrollment
2
Locations
2
Arms
113
Duration (Months)
50
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized pilot clinical trial studies survivorship care planning in improving the quality of life in breast cancer survivors. Survivorship care planning may reduce stress and improve the well-being and quality of life of cancer survivors.

Condition or Disease Intervention/Treatment Phase
  • Other: educational intervention
  • Other: counseling intervention
  • Procedure: standard follow-up care
  • Procedure: quality-of-life assessment
  • Other: questionnaire administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. Test the effectiveness of the navigation intervention and survivorship care plan (SCP)-breast cancer survivors (BCS) template booklet on accessing and adhering to SCP-BCS guidelines compared to the control group receiving usual care and the SCP-BCS template booklet.
SECONDARY OBJECTIVES:

  1. Develop a clinically and psychosocially responsive SCP-breast cancer survivors (SCP-BCS) template in English and English-Spanish adopted from American Society of Clinical Oncology (ASCO)-SCP.

  2. Assess the acceptability, utility and format preference (electronic vs paper) of the SCP-BCS template.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.

ARM II: Participants receive SCP-BCS template booklet and receive standard follow-up care.

After completion so study treatment, participants are followed up at 6 and 12 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Survivorship Care Planning for At Risk Breast Cancer Survivors
Study Start Date :
Jul 15, 2013
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (SCP-BCS template booklet and counseling)

Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.

Other: educational intervention
Receive the SCP-BCS template booklet
Other Names:
  • intervention, educational

    • Other: counseling intervention
    Receive counseling sessions with a patient navigator
    Other Names:
  • counseling and communications studies

    • Procedure: quality-of-life assessment
    Ancillary studies
    Other Names:
  • quality of life assessment

    • Other: questionnaire administration
    Ancillary studies
    Active Comparator: Arm II (SCP-BCS template booklet)

    Participants receive SCP-BCS template booklet and receive standard follow-up care.

    Other: educational intervention
    Receive the SCP-BCS template booklet
    Other Names:
  • intervention, educational

    • Procedure: standard follow-up care
    Receive standard follow-up care

    Procedure: quality-of-life assessment
    Ancillary studies
    Other Names:
  • quality of life assessment

    • Other: questionnaire administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of BCS accessing a SCP from their oncology provider [At 6 months]

      Fisher's exact test will be used to test the null hypothesis (at least 40% of trial participants will have access to SCP).

    Secondary Outcome Measures

    1. Adherence to SCP guidelines [At 12 months]

      Fisher's exact test will be used to test the null hypothesis (at least 25% of participants reporting adherence to SCP guidelines).

    2. Proportion of BCS accessing a SCP from their oncology provider [At 12 months]

      Fisher's exact test will be used to test the null hypothesis (at least 60% of trial participants will have access to SCP).

    Other Outcome Measures

    1. Develop a clinically and psychosocially responsive SCP-BCS template in English and a linguistically response bilingual version (English-Spanish) [Up to 12 months]

      The acceptability, utility, and format preference will also be assessed. A rating score will be generated for acceptability and utility and 95% confidence intervals for the proportion of BCS rating score at >= 4 will be assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • In early survivorship phase, defined as being post-surgery to ending of active treatment to 18 months post active treatment for stage 0-3 breast cancer (BCA)

    • Reside in Southern California

    • BCS treated at Kaiser, an health maintenance organization (HMO) provider, will be excluded since their SCP implementation project is underway

    • BCS will not be excluded based on cancer treatments received or a history of diagnosis of mild depression, anxiety, and hypertension and diabetes

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010
    2 City of Hope Antelope Valley Lancaster California United States 93534

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Kimlin Ashing-Giwa, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT01824745
    Other Study ID Numbers:
    • 12383
    • NCI-2013-00734
    First Posted:
    Apr 5, 2013
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Feb 18, 2022