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

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ClinicalTrials.gov Identifier: NCT04290962
Recruitment Status : Withdrawn (no accrual)
First Posted : March 2, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Cancer Survivor Behavioral: Lifestyle Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: African American Cancer Survivor Health: Pilot Implementation Research (National Witness Project® Witness Role Models Use Precision Nutrition)
Actual Study Start Date : January 17, 2019
Actual Primary Completion Date : October 14, 2020
Actual Study Completion Date : October 14, 2020

Resource links provided by the National Library of Medicine


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.
Behavioral: Lifestyle Therapy
Complete web-based lifestyle intervention

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Rate of enrollment [ Time Frame: Up to 12 months ]
  2. Rate of refusal [ Time Frame: Up to 12 months ]
  3. 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.

  4. 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.

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

  6. 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.


Other Outcome Measures:
  1. Self-reported cancer related-outcome collection [ Time Frame: Up to 12 months ]
    On line assessments will be completed



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04290962


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Julia Devonish Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT04290962    
Other Study ID Numbers: I 77418
NCI-2019-06115 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 77418 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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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