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

Not Applicable

Active, not recruiting

• Conditions: Cancer Survivor; Breast Cancer
• Interventions: Other: educational intervention; Procedure: standard follow-up care; Other: counseling intervention; Procedure: quality-of-life assessment; Other: questionnaire administration

• Registration Number: NCT01824745
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-02
• Study First Posted: 2013-04-05
• Study Start: 2013-07-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (SCP-BCS template booklet and counseling)	quality-of-life assessment	Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.
Arm II (SCP-BCS template booklet)	educational intervention	Participants receive SCP-BCS template booklet and receive standard follow-up care.
Arm II (SCP-BCS template booklet)	standard follow-up care	Participants receive SCP-BCS template booklet and receive standard follow-up care.
Arm I (SCP-BCS template booklet and counseling)	counseling intervention	Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.
Arm II (SCP-BCS template booklet)	quality-of-life assessment	Participants receive SCP-BCS template booklet and receive standard follow-up care.
Arm II (SCP-BCS template booklet)	questionnaire administration	Participants receive SCP-BCS template booklet and receive standard follow-up care.
Arm I (SCP-BCS template booklet and counseling)	educational intervention	Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.
Arm I (SCP-BCS template booklet and counseling)	questionnaire administration	Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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).

Trial Locations

Locations (2)

City of Hope Antelope Valley; 🇺🇸 Lancaster, California, United States

City of Hope Medical Center; 🇺🇸 Duarte, California, United States