Web-Based Lifestyle Intervention for the Improvement of Health in African American Cancer Survivors

April 25, 2023 updated by: Roswell Park Cancer Institute

African American Cancer Survivor Health: Pilot Implementation Research (National Witness Project® Witness Role Models Use Precision Nutrition)

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.

Study Overview

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

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Ancillary studies
Other Names:
  • Quality of Life Assessment
Ancillary studies
Complete web-based lifestyle intervention

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.
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.
Up to 12 months
Incidence of physical activity related injuries
Time Frame: Up to 12 months
Biweekly inquiries about possible injuries will be conducted.
Up to 12 months
Program effectiveness
Time Frame: Up to 12 months
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

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
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Julia Devonish, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2019

Primary Completion (Actual)

October 14, 2020

Study Completion (Actual)

October 14, 2020

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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