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

Cancer Survivor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04290962
• Other study ID #: I 77418
• Secondary ID: NCI-2019-06115I
• Status: Withdrawn
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: October 14, 2020

Study information

• Verified date: April 2023
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 14, 2020
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer Survivor

Intervention

Behavioral:
• Lifestyle Therapy
Complete web-based lifestyle intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported cancer related-outcome collection	On line assessments will be completed	Up to 12 months
Primary	Rate of enrollment		Up to 12 months
Primary	Rate of refusal		Up to 12 months
Primary	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
Primary	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
Primary	Incidence of physical activity related injuries	Biweekly inquiries about possible injuries will be conducted.	Up to 12 months
Primary	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