Community-Based Physical Activity Intervention for Underserved Cancer Survivors

Malignant Solid Neoplasm Clinical Trial

Official title:

Community-Based Physical Activity Across the Cancer Continuum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206863
• Other study ID #: I 3414922
• Secondary ID: NCI-2023-10434I
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 30, 2027

Study information

• Verified date: April 2024
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Exercise Intervention
Participate in virtual exercise classes
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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