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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Survivorship Care Planning for At Risk Breast Cancer Survivors

Conditions
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Breast Cancer, Cancer Survivor

Intervention / Treatment
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* Other: educational intervention
* Other: counseling intervention
* Procedure: standard follow-up care
* Procedure: quality-of-life assessment
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (SCP-BCS template booklet and counseling)<br>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<br>* Receive the SCP-BCS template booklet<br>* Other names: intervention, educational;Other: counseling intervention<br>* Receive counseling sessions with a patient navigator<br>* Other names: counseling and communications studies;Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (SCP-BCS template booklet)<br>Participants receive SCP-BCS template booklet and receive standard follow-up care. | Other: educational intervention<br>* Receive the SCP-BCS template booklet<br>* Other names: intervention, educational;Procedure: standard follow-up care<br>* Receive standard follow-up care<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of BCS accessing a SCP from their oncology provider | Fisher's exact test will be used to test the null hypothesis (at least 40% of trial participants will have access to SCP). | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to SCP guidelines | Fisher's exact test will be used to test the null hypothesis (at least 25% of participants reporting adherence to SCP guidelines). | At 12 months | 
| Proportion of BCS accessing a SCP from their oncology provider | Fisher's exact test will be used to test the null hypothesis (at least 60% of trial participants will have access to SCP). | At 12 months |