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

Roswell Park Comprehensive Cancer Center logo

Roswell Park Comprehensive Cancer Center

Status

Withdrawn

Conditions

Cancer Survivor

Treatments

Other: Questionnaire Administration
Behavioral: Lifestyle Therapy
Other: Quality-of-Life Assessment

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04290962
I 77418 (Other Identifier)
NCI-2019-06115 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Supportive Care (web-based lifestyle intervention)
Experimental group
Description:
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.
Treatment:
Other: Quality-of-Life Assessment
Behavioral: Lifestyle Therapy
Other: Questionnaire Administration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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