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

Primary Purpose

Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anatomic Stage I Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health services research (patient navigator)

Arm Description

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.

Outcomes

Primary Outcome Measures

Recruitment rate
Will be calculated as the number of new eligible women per month.
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.
Dropout rate
Will be calculated as the percentage of women who are enrolled in the study but withdraw before the conclusion of the study.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
December 21, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05674578
Brief Title
Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors
Official Title
Supporting Black Breast Cancer Survivors: Feasibility Trial of Health Coaching-Based Navigation at the Conclusion of Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health services research (patient navigator)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Other Intervention Name(s)
Patient Navigator Program
Intervention Description
Assigned a patient navigator and receive coaching
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Will be calculated as the number of new eligible women per month.
Time Frame
Up to 6 months
Title
Consent rate
Description
Will be calculated as the number of consented women (set to 40 for this study) divided by the total number of women approached.
Time Frame
Up to 6 months
Title
Dropout rate
Description
Will be calculated as the percentage of women who are enrolled in the study but withdraw before the conclusion of the study.
Time Frame
Up to 6 months
Title
Patient-Reported Outcomes Measurement Information System score
Description
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.
Time Frame
Up to 6 months
Title
European Organization for Research and Treatment of Cancer Quality of Life-30 score
Description
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.
Time Frame
Up to 6 months
Title
Breast Cancer Self Efficacy Scale score
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Black women > 18 years of age with stage I-III primary breast cancer who have completed definitive breast cancer treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
The Ohio State Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bridget A Oppong, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bridget A. Oppong, MD
Phone
614-293-6408
Email
bridget.oppong@osumc.edu
First Name & Middle Initial & Last Name & Degree
Bridget A. Oppong, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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