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NCT Number: NCT01824745

Survivorship Care Planning in Improving the Quality of Life in 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer Survivor Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center, Duarte, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Receive the SCP-BCS template booklet

Other names: intervention, educational

counseling intervention

Other

Receive counseling sessions with a patient navigator

Other names: counseling and communications studies

standard follow-up care

Procedure

Receive standard follow-up care

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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

  1. 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).

  2. 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).

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Survivorship Care Planning for At Risk Breast Cancer Survivors

Important dates

Study start
2013
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2013
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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