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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-08425 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health services research (patient navigator) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Navigation | Behavioral | Assigned a patient navigator and receive coaching |
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| 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 | 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. | Up to 6 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bridget A Oppong, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 29, 2021 | Mar 18, 2025 |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| ICF_000.pdf |
| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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