Menu
Recruiting NCT06565260

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

No phase Interventional Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise Intervention, Medical Device Usage and Evaluation, Nutritional Intervention, Physical Performance Testing.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Feasibility of a Community-Based Cancer Survivor Exercise and Nutrition Education Program: Effects on Self-Efficacy, Quality of Life and Functional Performance

Overview

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.

Interventions

  • Other Exercise Intervention
    Participate in exercise program
  • Other Medical Device Usage and Evaluation
    Wear an activity tracker
  • Other Nutritional Intervention
    Participate in nutrition program
  • Other Physical Performance Testing
    Ancillary studies
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • Proportion of patients still on study (Feasibility) [Time frame: At the end of the 12 week intervention]
  • Percentage of patients on study after 12 weeks who complete at least 70% of intervention activities (Acceptability) [Time frame: At 12 weeks]
  • Patient satisfaction (Acceptability) [Time frame: Baseline to 3 months post-intervention]
Secondary outcome measures (1)
  • Changes in exercise and nutrition self-efficacy [Time frame: Baseline to 3 months post-intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Roswell Park Cancer Institute — Buffalo

Identifiers

NCT: NCT06565260 · I-3953124 · NCI-2024-06518 · I-3953124

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗