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

N/AActive Not RecruitingNCT01824745

City of Hope Medical Center100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

100

Conditions

Breast Cancer Cancer Survivor

Interventions

educational interventionOTHER

Receive the SCP-BCS template booklet

counseling interventionOTHER

Receive counseling sessions with a patient navigator

standard follow-up carePROCEDURE

Receive standard follow-up care

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

City of Hope Medical Center

Duarte, California, United States

City of Hope Antelope Valley

Lancaster, California, United States

Outcomes

Primary Outcomes

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).

Time frame: At 6 months

Secondary Outcomes

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).

Time frame: 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).

Time frame: At 12 months

Data from ClinicalTrials.gov

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