Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
Detailed description
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.
Interventions
OTHERExercise Intervention
Participate in virtual exercise classes
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 - self reported by participant * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients referred to the intervention (Feasibility) | 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. |
| Proportion of patients that enrolled in the study (Feasibility) | 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. |
| Retention rate (Feasibility) | 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. |
| Adherence rate (Acceptability) | 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. |
| Patient satisfaction (Acceptability) | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall quality of life | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrew D Ray
Roswell Park Cancer Institute
Outcome results
None listed