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NCT06565260 | RECRUITING | Hematopoietic and Lymphatic System Neoplasm

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

Roswell Park Cancer Institute

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.

Condition or disease

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Intervention/treatment

Exercise Intervention

Medical Device Usage and Evaluation

Nutritional Intervention

Physical Performance Testing

Questionnaire Administration

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Feasibility of a Community-Based Cancer Survivor Exercise and Nutrition Education Program: Effects on Self-Efficacy, Quality of Life and Functional Performance
Actual Study Start Date : 2025-04-15
Estimated Primary Completion Date : 2029-08-30
Estimated Study Completion Date : 2029-08-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age ≥ 18 years.
  • * Have had a previous cancer diagnosis and completed all therapy.
  • * 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.
Community-Based Exercise and Nutrition Training and Education Program for Cancer Survivors

Location Details

NCT06565260

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263