Clinical trial NCT04290962: Web-Based Lifestyle Intervention for the Improvement of Health in African American Cancer Survivors
Official title: African American Cancer Survivor Health: Pilot Implementation Research (National Witness Project® Witness Role Models Use Precision Nutrition)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer Survivor
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of enrollment
timeFrame: Up to 12 months
measure: Rate of refusal
timeFrame: Up to 12 months
measure: Program adherence rate
timeFrame: Up to 12 months
measure: Program retention
timeFrame: Up to 12 months
measure: Incidence of physical activity related injuries
timeFrame: Up to 12 months
measure: Program effectiveness
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
measure: Self-reported cancer related-outcome collection
timeFrame: Up to 12 months
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Julia Devonish
role: PRINCIPAL_INVESTIGATOR
References: