Community-Based Exercise and Nutrition Training and Education Program for Cancer Survivors

NCT ID: NCT06565260

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2029-08-30

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive Care (exercise/nutrition program)

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

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: OTHER

Participate in exercise program

Medical Device Usage and Evaluation

Intervention Type: OTHER

Wear an activity tracker

Nutritional Intervention

Intervention Type: OTHER

Participate in nutrition program

Physical Performance Testing

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Exercise Intervention

Participate in exercise program

Intervention Type: OTHER

Medical Device Usage and Evaluation

Wear an activity tracker

Intervention Type: OTHER

Nutritional Intervention

Participate in nutrition program

Intervention Type: OTHER

Physical Performance Testing

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Physical Fitness Testing; Physical Function Testing

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew D Ray

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Andrew D. Ray

Role: primary

Other Identifiers

NCI-2024-06518

Identifier Type: REGISTRY

Identifier Source: secondary_id

I-3953124

Identifier Type: OTHER

Identifier Source: secondary_id

I-3953124

Identifier Type: -

Identifier Source: org_study_id