Community-Based Physical Activity Intervention for Underserved Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 - self reported by participant
Are unwilling or unable to follow protocol requirements
Trial design
Design model
Single group
Treatments tested in this trial
Exercise Intervention
Other interventionParticipate in virtual exercise classes
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Supportive Care (virtual exercise classes)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 12 weeks2
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.
Time frame
Up to 12 weeks3
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.
Time frame
At the end of the 12-week intervention4
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.
Time frame
At post 12-weeksSecondary outcomes
1
Overall quality of life
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.
Time frame
Up to 12 weeksSponsors and contacts
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Source ClinicalTrials.gov