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

NCT04290962 | Withdrawn

• 2 other identifiers: I 77418NCI-2019-06115
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivor

Outcome Measures

Primary Outcomes (6)

• Rate of enrollment

  Up to 12 months

• Rate of refusal

  Up to 12 months

• 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

• 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

• Incidence of physical activity related injuries

  Biweekly inquiries about possible injuries will be conducted.

  Up to 12 months

• 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

Other Outcomes (1)

• Self-reported cancer related-outcome collection

  Up to 12 months

Study Arms (1)

Supportive Care (web-based lifestyle intervention)

EXPERIMENTAL

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.

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

Interventions

Lifestyle Therapy BEHAVIORAL

Complete web-based lifestyle intervention

Supportive Care (web-based lifestyle intervention)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care (web-based lifestyle intervention)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (web-based lifestyle intervention)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Study Officials

• Julia Devonish

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: January 17, 2019
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

US (1)