Community-Based Exercise Oncology: Real-World Evidence of High Adherence, Improved Quality of Life and Cost-Effectiveness Across the Cancer Continuum
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 492
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
This prospective observational cohort study evaluates a community-based supervised exercise oncology program delivered in real-world settings in Madrid, Spain. The program is designed for adults with a cancer diagnosis across the cancer continuum, including survivors, patients undergoing active treatment, individuals receiving hormonotherapy, and patients with metastatic disease.
Participants take part in a structured multimodal exercise program combining aerobic, resistance, and functional training, delivered in supervised group-based sessions either in person or through synchronous online formats. The primary aims of the study are to assess program adherence, health-related quality of life, fatigue, and cost-effectiveness, expressed as quality-adjusted life years (QALYs). Secondary outcomes include cardiorespiratory fitness, muscular strength, functional capacity, physical activity levels, body composition, and psychological well-being.
Assessments are conducted at baseline and every four months over a 12-month follow-up period. This study provides real-world evidence on the feasibility, clinical impact, and economic value of community-based exercise oncology programs across different stages of the cancer trajectory.
详细描述
This study is a prospective observational cohort analysis of adults with a confirmed cancer diagnosis participating in a community-based supervised exercise oncology program in Madrid, Spain. Participants are referred by oncology specialists or self-referred with medical clearance to engage in moderate-intensity physical exercise.
The intervention consists of supervised multimodal exercise sessions lasting approximately 75 minutes, including warm-up, combined aerobic and resistance training, and cool-down periods. Aerobic training is prescribed using heart rate reserve and perceived exertion scales, while resistance training includes free-weight and functional exercises targeting major muscle groups. Sessions are delivered in small groups either face-to-face or via synchronous online platforms, with individualized progression and safety monitoring.
Participants undergo standardized assessments at baseline and at 4, 8, and 12 months. Primary outcomes include adherence to supervised exercise sessions, health-related quality of life, fatigue, and cost-effectiveness measured through quality-adjusted life years derived from EQ-5D instruments. Secondary outcomes include estimated cardiorespiratory fitness, muscular strength, functional capacity tests, physical activity behavior, body composition, and psychological outcomes.
The study aims to generate real-world evidence on the feasibility, effectiveness, and economic impact of integrating structured exercise programs into community-based cancer care across different clinical stages of disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Confirmed diagnosis of cancer, at any stage of disease.
- •Medical clearance to perform moderate-intensity physical exercise.
- •Able to ambulate independently without assistive devices.
- •Willingness to attend supervised exercise sessions for a follow-up period of at least 12 months.
排除标准
- •Absolute medical contraindications to exercise (e.g., unstable angina, uncontrolled arrhythmias, severe anemia, acute infection, or thrombosis).
- •Unstable metastatic bone disease without radiologic and/or oncologic clearance.
- •Cognitive or functional impairment preventing safe participation in the exercise program.
- •Concurrent participation in another structured exercise intervention or clinical trial.
研究组 & 干预措施
Active Cancer Treatment
Adults with a cancer diagnosis undergoing active oncological treatment, excluding hormonotherapy, who were participating in the supervised community-based exercise oncology program.
Hormone therapy
Adults with a cancer diagnosis receiving hormonotherapy who were enrolled in the supervised community-based exercise oncology program.
Metastatic
Adults with metastatic cancer participating in the supervised community-based exercise oncology program, with medical clearance for moderate-intensity exercise.
cancer survivors
Adults with a previous cancer diagnosis who had completed primary oncological treatment and were participating in a community-based supervised exercise oncology program.
结局指标
主要结局
Adherence
时间窗: Baseline, 4 months, 8 months, and 12 months.
Percentage of supervised exercise sessions completed out of scheduled sessions.
Health-related quality of life (FACT-G)
时间窗: Baseline, 4 months, 8 months, and 12 months.
Health-related quality of life (units on a scale) assessed using the Functional Assessment of Cancer Therapy - General (FACT-G)
Fatigue (FACT-F)
时间窗: Baseline, 4 months, 8 months, and 12 months.
Fatigue (units on a scale) assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F).
Quality-adjusted life years (QALYs)
时间窗: Baseline, 4 months, 8 months, and 12 months.
Quality-adjusted life years calculated by integrating EQ-5D utility scores collected at multiple time points over the 12-month follow-up period. Repeated EQ-5D measurements are aggregated to derive a single QALY value per participant.
Barriers to participation
时间窗: Baseline, 4 months, 8 months, and 12 months.
Using a structured questionnaire based on previously published frameworks on determinants of adherence in cancer survivors.
次要结局
- Estimated VO₂max(Baseline, 4 months, 8 months, and 12 months.)
- Muscular strength(Baseline, 4 months, 8 months, and 12 months.)
- Functional capacity(Baseline, 4 months, 8 months, and 12 months.)
- Body weight (kg)(Baseline, 4 months, 8 months, and 12 months.)
- Body Fat Percentage (%)(Baseline, 4 months, 8 months, and 12 months.)
- Fat Mass (kg)(Baseline, 4 months, 8 months, and 12 months.)
- Lean Mass Percentage (%)(Baseline, 4 months, 8 months, and 12 months.)
- Lean Mass (kg)(Baseline, 4 months, 8 months, and 12 months.)
- Physical activity(Baseline, 4 months, 8 months, and 12 months.)
- Anxiety (HADS-A)(Baseline, 4 months, 8 months, and 12 months.)
- Depression (HADS-D)(Baseline, 4 months, 8 months, and 12 months.)