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NCT Number: NCT06206863

Community-Based Physical Activity Intervention for Underserved Cancer Survivors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location status: Recruiting

Location contact

Andrew D. Ray

CONTACT

[email protected]

716-845-2381

Andrew D. Ray

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVE:

I. To assess the feasibility and acceptability of a community-based 12-week physical activity intervention.

SECONDARY OBJECTIVE:

I. To assess the effectiveness of a virtual physical activity intervention by evaluating pre-post changes in quality of life (QoL).

EXPLORATORY OBJECTIVE (OPTIONAL):

I. To virtually assess changes in functional performance in a small subgroup.

OUTLINE:

Participants participate in virtual exercise classes at least three times a week (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.

After completion of study intervention, patients are followed up at 1 week.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Exercise intervention

Other

Participate in virtual exercise classes

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Proportion of patients referred to the intervention (Feasibility)

    Time frame: Up to 12 weeks

    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.

  2. Proportion of patients that enrolled in the study (Feasibility)

    Time frame: Up to 12 weeks

    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.

  3. Retention rate (Feasibility)

    Time frame: At the end of the 12-week intervention

    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.

  4. Adherence rate (Acceptability)

    Time frame: At post 12-weeks

    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.

  5. Patient satisfaction (Acceptability)

    Time frame: Up to 12 weeks

    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.

Secondary outcomes

  1. Overall quality of life

    Time frame: Up to 12 weeks

    Will assess the changes in physical functioning, sustained physical activity, and quality of life using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) score.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

Community-Based Physical Activity Across the Cancer Continuum

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2024
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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