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

March 11, 2026 updated by: City of Hope Medical Center

Survivorship Care Planning for At Risk Breast Cancer Survivors

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center
      • Lancaster, California, United States, 93534
        • City of Hope Antelope Valley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
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
Active Comparator: Arm II (SCP-BCS template booklet)
Participants receive SCP-BCS template booklet and receive standard follow-up care.
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Other: educational intervention
Receive the SCP-BCS template booklet
Other Names:
  • intervention, educational
Procedure: standard follow-up care
Receive standard follow-up care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to SCP guidelines
Time Frame: 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).
At 12 months
Proportion of BCS accessing a SCP from their oncology provider
Time Frame: 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).
At 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop a clinically and psychosocially responsive SCP-BCS template in English and a linguistically response bilingual version (English-Spanish)
Time Frame: 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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 15, 2013

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (Estimated)

April 5, 2013

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12383
  • NCI-2013-00734 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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