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Completed

NCT Number: NCT05674578

Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors

This clinical trial evaluates the feasibility of coaching-based navigation for black breast cancer survivors including recruitment, dropout, and survey completion rates. A coaching-based navigation may perform a needs assessment and coach the participant to access relevant supportive content including physical rehabilitation, emotional and psychosocial support, and nutrition and exercise programming. This trial aims to see whether this navigation program may improve the quality of life of black breast cancer survivors.

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Key information

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

PRIMARY OBJECTIVE:

I. To evaluate the feasibility of coaching-based navigation for black breast cancer survivors including recruitment, dropout, and survey completion rates.

SECONDARY OBJECTIVES:

I. To evaluate the preliminary impact of health coaching on completion of scheduled survivorship related referrals and participation in support services.

II. To determine the preliminary impact on quality of life and self-efficacy pre and post coaching.

OUTLINE:

Patients are assigned a Black patient navigator for racial concordance and receive coaching from patient navigator over 30 minutes every other week for 3 months and then monthly for 3 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Black women > 18 years of age with stage I-III primary breast cancer who have completed definitive breast cancer treatment

Treatment and study plan

Patient Navigation

Behavioral

Assigned a patient navigator and receive coaching

Other names: Patient Navigator Program

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Recruitment rate

    Time frame: Up to 6 months

    Will be calculated as the number of new eligible women per month.

  2. Consent rate

    Time frame: Up to 6 months

    Will be calculated as the number of consented women (set to 40 for this study) divided by the total number of women approached.

  3. Dropout rate

    Time frame: Up to 6 months

    Will be calculated as the percentage of women who are enrolled in the study but withdraw before the conclusion of the study.

  4. Patient-Reported Outcomes Measurement Information System score

    Time frame: Up to 6 months

    Differences in scoring at the start of the study period and at the end of the trial will also be summarized by mean, standard deviation, and range.

  5. European Organization for Research and Treatment of Cancer Quality of Life-30 score

    Time frame: Up to 6 months

    Differences in scoring at the start of the study period and at the end of the trial will also be summarized by mean, standard deviation, and range.

  6. Breast Cancer Self Efficacy Scale score

    Time frame: Up to 6 months

    A self reported, unidimensional, 11 item scale designed to show the differences in scoring at the start of the study period and at the end of the trial will also be summarized by mean, standard deviation, and range.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Supporting Black Breast Cancer Survivors: Feasibility Trial of Health Coaching-Based Navigation at the Conclusion of Treatment

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2023
Registry last updated
Mar 25, 2025

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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