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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-10434 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 3414922 | Other Identifier | Roswell Park Cancer Institute |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Other | Participate in virtual exercise classes |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Ray | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Up to 12 weeks |