Clinical trial NCT06565260: Community-Based Exercise and Nutrition Training and Education Program for Cancer Survivors
Official title: Feasibility of a Community-Based Cancer Survivor Exercise and Nutrition Education Program: Effects on Self-Efficacy, Quality of Life and Functional Performance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial evaluates whether a supervised community-based exercise and nutrition program is usable and effective for improving cancer survivors' confidence for maintaining their physical activity and nutrition. Cancer survivors often experience problems with the musculoskeletal system (bones, joints, muscles, connective tissue), the cardiopulmonary system (heart, blood vessels and lungs) and the metabolic system (how the body's cells change food into energy) following treatment. There is substantial evidence that physical activity, diet, and weight management can improve quality of life (emotional and physical well-being) and physical fitness. Information gathered from this study may help researchers determine whether participating in a community-based exercise/nutrition training and education program may improve levels of fitness, cardiovascular health, and quality of life for cancer survivors.

Detailed description: PRIMARY OBJECTIVE:

I. To assess the feasibility and acceptability of a 12-week supervised community-based exercise/nutrition training and education program for cancer survivors.

SECONDARY OBJECTIVE:

I. To assess the effectiveness of a supervised exercise and nutrition training and education program by evaluating pre-post changes in exercise self-efficacy.

TERTIARY OBJECTIVE:

I. To assess changes in functional performance and quality of life (QoL).

OUTLINE:

Patients participate in a supervised, community-based exercise program consisting of aerobic and resistance exercise over 45-60 minutes twice a week (BIW) for 12 weeks. Beginning at week 2, patients also receive nutrition education and training once a week (QW) for 10 weeks. Patients also wear an activity tracker throughout the study.

After completion of study intervention, patients are followed up at 3 months.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Have had a previous cancer diagnosis and completed all therapy OR are a caregiver for a patient who has had a previous cancer diagnosis.
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related interventions.

Exclusion Criteria:

* Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia including 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.
* History of a stem cell transplant.
* Currently on steroids.
* Unwilling or unable to follow protocol requirements.
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study.

Primary outcomes:
measure: Proportion of patients still on study (Feasibility)
timeFrame: At the end of the 12 week intervention
measure: Percentage of patients on study after 12 weeks who complete at least 70% of intervention activities (Acceptability)
timeFrame: At 12 weeks
measure: Patient satisfaction (Acceptability)
timeFrame: Baseline to 3 months post-intervention
Secondary outcomes:
measure: Changes in exercise and nutrition self-efficacy
timeFrame: Baseline to 3 months post-intervention
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: