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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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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

Intervention / Treatment
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* Behavioral: Patient Navigation
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Black women > 18 years of age with stage I-III primary breast cancer who have completed definitive breast cancer treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health services research (patient navigator)<br>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. | Behavioral: Patient Navigation<br>* Assigned a patient navigator and receive coaching<br>* Other names: Patient Navigator Program;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Will be calculated as the number of new eligible women per month. | Up to 6 months | 
| Consent rate | Will be calculated as the number of consented women (set to 40 for this study) divided by the total number of women approached. | Up to 6 months | 
| Dropout rate | Will be calculated as the percentage of women who are enrolled in the study but withdraw before the conclusion of the study. | Up to 6 months | 
| Patient-Reported Outcomes Measurement Information System score | 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. | Up to 6 months | 
| European Organization for Research and Treatment of Cancer Quality of Life-30 score | 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. | Up to 6 months | 
| Breast Cancer Self Efficacy Scale score | 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. | Up to 6 months |