Survivorship Care Planning for At Risk Breast Cancer Survivors
Overview
- Phase
- N/A
- Intervention
- educational intervention
- Conditions
- Breast Cancer
- Sponsor
- City of Hope Medical Center
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Proportion of BCS accessing a SCP from their oncology provider
- Status
- Active, Not Recruiting
- Last Updated
- last month
Overview
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.
Detailed Description
PRIMARY OBJECTIVES: I. 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: I. 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. II. 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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: educational intervention
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.
Intervention: counseling intervention
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.
Intervention: quality-of-life assessment
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.
Intervention: questionnaire administration
Arm II (SCP-BCS template booklet)
Participants receive SCP-BCS template booklet and receive standard follow-up care.
Intervention: educational intervention
Arm II (SCP-BCS template booklet)
Participants receive SCP-BCS template booklet and receive standard follow-up care.
Intervention: standard follow-up care
Arm II (SCP-BCS template booklet)
Participants receive SCP-BCS template booklet and receive standard follow-up care.
Intervention: quality-of-life assessment
Arm II (SCP-BCS template booklet)
Participants receive SCP-BCS template booklet and receive standard follow-up care.
Intervention: questionnaire administration
Outcomes
Primary Outcomes
Proportion of BCS accessing a SCP from their oncology provider
Time Frame: 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 Outcomes
- Proportion of BCS accessing a SCP from their oncology provider(At 12 months)
- Adherence to SCP guidelines(At 12 months)