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Trial Title:
Community-Based Exercise and Nutrition Training and Education Program for Cancer Survivors
NCT ID:
NCT06565260
Condition:
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Participate in exercise program
Arm group label:
Supportive Care (exercise/nutrition program)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear an activity tracker
Arm group label:
Supportive Care (exercise/nutrition program)
Intervention type:
Other
Intervention name:
Nutritional Intervention
Description:
Participate in nutrition program
Arm group label:
Supportive Care (exercise/nutrition program)
Intervention type:
Other
Intervention name:
Physical Performance Testing
Description:
Ancillary studies
Arm group label:
Supportive Care (exercise/nutrition program)
Other name:
Physical Fitness Testing
Other name:
Physical Function Testing
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Supportive Care (exercise/nutrition program)
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Contact:
Last name:
Andrew D. Ray
Phone:
716-845-2381
Email:
Andrew.Ray@roswellpark.org
Investigator:
Last name:
Andrew D. Ray
Email:
Principal Investigator
Start date:
December 15, 2024
Completion date:
August 30, 2029
Lead sponsor:
Agency:
Roswell Park Cancer Institute
Agency class:
Other
Source:
Roswell Park Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06565260
