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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-06115 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 77418 | Other Identifier | Roswell Park Cancer Institute |
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This early phase I trial studies how well a web-based lifestyle intervention called Precision Nutrition Coaching Program works in improving health in African American cancer survivors. Participating in the web-based lifestyle intervention program reinforced with experienced lifestyle coaches and consisting of physical activity, nutritional/lifestyle habits, and educational lessons may help to improve overall health and well-being, fitness level, and quality of life in African American cancer survivors.
PRIMARY OBJECTIVE:
I. To conduct a pilot implementation research study to determine the viability, safety, and effectiveness of the use of a 12-month, commercially available, web-based lifestyle behavioral medicine intervention program by individuals who are or have been a Witness Role Model (WRM) in the National Witness Project (NWP).
SECONDARY OBJECTIVE:
I. To examine the feasibility of this research to subsequently investigate the effects of optimal health and/or lifestyle related behavioral medicine interventions used to promote optimal health on mitigating cancer-related and overall mortality disparities in African Americans (AA), and comorbidity/ chronic disease(s) management over time. (EXPLORATORY)
OUTLINE:
Participants complete the 12-month Precision Nutrition Coaching Program web-based lifestyle intervention consisting of physical activity at home or a local gym, nutritional/lifestyle habit with a new focus biweekly, and educational lessons about health, nutrition, fitness, or behavior change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (web-based lifestyle intervention) | Experimental | Participants complete the 12-month Precision Nutrition Coaching Program web-based lifestyle intervention consisting of physical activity at home or a local gym, nutritional/lifestyle habit with a new focus biweekly, and educational lessons about health, nutrition, fitness, or behavior change. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Therapy | Behavioral | Complete web-based lifestyle intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of enrollment | Up to 12 months | |
| Rate of refusal | Up to 12 months | |
| Program adherence rate | Measured by participation and online tracking of activity completion (workout, habit, and lessons). An overall adherence score will be calculated by averaging the percentage of time each of the 3 activities were completed by each participant over the 12-month intervention. | Up to 12 months |
| Program retention | Will be measured by the proportion of participants who are still participating in the study at the end of the 12-month intervention. | Up to 12 months |
| Incidence of physical activity related injuries | Biweekly inquiries about possible injuries will be conducted. | Up to 12 months |
| Program effectiveness | The effects of the lifestyle intervention program will be ascertained via primarily subjective, self-reported assessments administered at pre-intervention, post-intervention, and a follow-up. Subjective data will be validated through the collection of objective data in a subset of local participants via in-person assessments. Generalized linear mixed model methods, specifically a repeated measures analysis of variance with a random participant effect, as well as fixed effects for time and interaction will be used. | Up to 12 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Self-reported cancer related-outcome collection | On line assessments will be completed | Up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Devonish | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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