Clinical trial NCT06206863: Community-Based Physical Activity Intervention for Underserved Cancer Survivors
Official title: Community-Based Physical Activity Across the Cancer Continuum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients referred to the intervention (Feasibility)
timeFrame: Up to 12 weeks
measure: Proportion of patients that enrolled in the study (Feasibility)
timeFrame: Up to 12 weeks
measure: Retention rate (Feasibility)
timeFrame: At the end of the 12-week intervention
measure: Adherence rate (Acceptability)
timeFrame: At post 12-weeks
measure: Patient satisfaction (Acceptability)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Overall quality of life
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Andrew D Ray
role: PRINCIPAL_INVESTIGATOR
References: