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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Proportion of patients still on study (Feasibility) [Срок оценки: 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) [Срок оценки: At 12 weeks]
• Patient satisfaction (Acceptability) [Срок оценки: Baseline to 3 months post-intervention]

Вторичные конечные точки (1)

• Changes in exercise and nutrition self-efficacy [Срок оценки: Baseline to 3 months post-intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Roswell Park Cancer Institute — Buffalo

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗