- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04290962
Web-Based Lifestyle Intervention for the Improvement of Health in African American Cancer Survivors
African American Cancer Survivor Health: Pilot Implementation Research (National Witness Project® Witness Role Models Use Precision Nutrition)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Has contacted study investigators using the contact information found on recruitment materials to convey their interest in participating
- Verbally confirmed that they now currently or in the past have functioned as a WRM for NWP
- Body mass index (BMI) >= 23
- Weight stable over the past year (=< 10% change)
- Current levels of physical activity were assessed and compared to United States (US) Centers for Disease Control and Prevention (CDC) Physical Activity (PA) guidelines (150 minutes of moderately intensive weekly physical activity)
- Cleared to participate in an exercise program via the American College of Sports Medicine Exercise Pre-participation Health Screening Guidelines
- Has access to internet and a computer/tablet etc
- Has access to basic fitness equipment (dumbbells, resistance bands) and/or is willing to join a fitness facility
- Is currently under the care of and has been assessed by a primary care physician within the last 12 months
- Understands the investigational nature of this study and completes the process of informed consent per Institutional Review Board (IRB) approved protocol
Exclusion Criteria:
- Has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Is pregnant or nursing
- Is unwilling or unable to participate
- Has any condition which in the investigators' opinion(s) deems the subject an unsuitable candidate to participate in this study
- Has metastatic cancer
- Has an orthopedic disorder, neuromuscular disorder or other condition (e.g., arthritis, morbid obesity) that may significantly preclude participation in exercise or related behaviors
- Is currently incarcerated (i.e., prisoner)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supportive Care (web-based lifestyle intervention)
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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Ancillary studies
Other Names:
Ancillary studies
Complete web-based lifestyle intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of enrollment
Time Frame: Up to 12 months
|
Up to 12 months
|
|
Rate of refusal
Time Frame: Up to 12 months
|
Up to 12 months
|
|
Program adherence rate
Time Frame: Up to 12 months
|
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.
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Up to 12 months
|
Program retention
Time Frame: Up to 12 months
|
Will be measured by the proportion of participants who are still participating in the study at the end of the 12-month intervention.
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Up to 12 months
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Incidence of physical activity related injuries
Time Frame: Up to 12 months
|
Biweekly inquiries about possible injuries will be conducted.
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Up to 12 months
|
Program effectiveness
Time Frame: Up to 12 months
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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.
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Up to 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported cancer related-outcome collection
Time Frame: Up to 12 months
|
On line assessments will be completed
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Up to 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Julia Devonish, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- I 77418 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2019-06115 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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