Community-Based Physical Activity Intervention for Underserved Cancer Survivors

NCT06206863 | Recruiting

• 2 other identifiers: I 3414922NCI-2023-10434
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial evaluates a community-based physical activity program for underserved cancer survivors. Cancer and its treatment significantly influence physical, psychosocial, and cognitive functioning. Historically, community sites (local and national) have not been staffed to offer support services such as physical, and occupational therapies (everyday life activities to promote health and well-being) or nutrition counselling, and do not offer a whole-person model of care. In this study, researchers have partnered with the YMCA to provide tailored home-based exercise programs for underserved cancer patients and survivors. Accessing exercise professionals may allow patients to prevent acute problems from becoming chronic, long-lasting physically weak impairments that directly influence patients' quality of life.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (5)

• Proportion of patients referred to the intervention (Feasibility)

  At the provider level, feasibility will be defined as the proportion of patients that were referred to the intervention versus (vs.) the proportion of patients that enrolled in the study. Will estimate the referral rates with 95% confidence intervals obtained from generalized estimating equation (GEE) logistic regression models, accounting for the within provider clustering.

  Up to 12 weeks

• Proportion of patients that enrolled in the study (Feasibility)

  At the provider level, feasibility will be defined as the proportion of patients that were referred to the intervention vs. the proportion of patients that enrolled in the study.

  Up to 12 weeks

• Retention rate (Feasibility)

  At the patient level, feasibility will be defined as the proportion of patients still on study. Will estimate with 95% confidence intervals obtained from GEE logistic regression models, accounting for the within provider clustering.

  At the end of the 12-week intervention

• Adherence rate (Acceptability)

  Adherence will be defined as the percentage of patients on study after 12-weeks who complete at least 70% of the intervention videos. Will estimate with 95% confidence intervals obtained from GEE logistic regression models, accounting for the within provider clustering.

  At post 12-weeks

• Patient satisfaction (Acceptability)

  Acceptability will be determined by measuring adherence to the intervention and by measuring patient satisfaction. Patient satisfaction will be determined through pre-post intervention surveys. Will use the appropriate generalized linear model (ex. linear or logistic), as determined by the question type and accounting for the within provider clustering.

  Up to 12 weeks

Secondary Outcomes (1)

• Overall quality of life

  Up to 12 weeks

Study Arms (1)

Supportive Care (virtual exercise classes)

EXPERIMENTAL

Participants participate in virtual exercise classes at least TIW over 20-60 minutes for 12 weeks. Participants are expected to work towards achieving the national physical activity exercise guidelines of 150 minutes of moderate intensity aerobic based physical activity and 2-3 strength training sessions each week.

Other: Exercise Intervention; Other: Questionnaire Administration

Interventions

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (virtual exercise classes)

Exercise Intervention OTHER

Participate in virtual exercise classes

Supportive Care (virtual exercise classes)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have had a previous cancer diagnosis OR are a caregiver for a patient who has had a previous cancer diagnosis
• Not in active treatment for cancer
• Over 18 years of age

You may not qualify if:

• Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, atrial fibrillation (AFIB), multiple myeloma, or psychiatric illness/social situations that would limit compliance with study requirements
• Have orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise
• Are pregnant or nursing
• Are unwilling or unable to follow protocol requirements
• Have any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Study Officials

• Andrew D Ray

  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: December 19, 2023
• First Posted: January 16, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)