Telerehabilitation in Cancer Patients: Optimization of Prehabilitation and Rehabilitation Following Colorectal Resection. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Functional Capacity - Six Minute Walking Test (6MWT)
研究概览
简要总结
This study, titled: Telerehabilitation in Oncology Patients: Optimization of Prehabilitation and Rehabilitation Post-Colorectal Resection. Is a randomized clinical trial conducted at the Royo Villanova Hospital in Zaragoza, Spain. It aims to evaluate the effectiveness of a tele-rehabilitation program in enhancing functional capacity and quality of life for patients undergoing colorectal cancer surgery. Colorectal cancer (CRC) is a highly prevalent malignant tumor that significantly impacts global health and patients' quality of life, particularly after surgery. Prehabilitation and postoperative rehabilitation are crucial for recovery, and telerehabilitation offers a promising alternative to improve outcomes in CRC patients.
详细描述
Study Background and Rationale: Colorectal cancer (CRC) is one of the most prevalent malignant tumors worldwide and a leading cause of cancer-related deaths. Despite advancements in surgical and oncological treatments, patients often experience significant postoperative complications and a decline in their quality of life. Prehabilitation, which aims to enhance a patient's functional capacity before surgery, has been identified as a promising approach to improve postoperative outcomes. However, traditional rehabilitation programs are often limited by patient adherence, accessibility, and the availability of resources, especially for those living in rural or underserved areas.
Objective
The primary objective of this study is to determine whether a 2-week prehabilitation and 4-week post-surgical rehabilitation program delivered via asynchronous telerehabilitation software can improve the functional capacity of patients undergoing colorectal cancer surgery, as measured by the Six Minute Walking Test (6MWT). Secondary objectives include assessing changes in body composition, muscle strength, pulmonary capacity, postoperative complications, psychosocial factors (such as quality of life, anxiety, depression, and sleep quality), adherence to the treatment, patient acceptance of the treatment, and the usability of the telerehabilitation platform.
Study Design: This is a single-blind, parallel-group randomized clinical trial. Fifty-four patients scheduled for colorectal cancer surgery will be recruited and randomly assigned to either the control group, which will receive conventional rehabilitation through a booklet, or the intervention group, which will receive the same rehabilitation program through a digital telerehabilitation platform. Both groups will undergo a comprehensive rehabilitation program including therapeutic education, respiratory exercises, aerobic exercises, and strength training.
Methodology: Patients will be assessed at five time points: pre-intervention, the day before surgery, 21 days post-surgery, 50 days post-surgery, and 3-month follow-up. The telerehabilitation platform will allow patients to access exercise videos and therapeutic content asynchronously, with the ability to communicate with their physiotherapists through the platform for guidance and support. The booklet will allow patients to access the program through pictures and text.
Clinical implications: Telerehabilitation represents an innovative approach to overcoming barriers associated with conventional rehabilitation, particularly in improving accessibility for patients in remote areas. By demonstrating the clinical efficacy of telerehabilitation, this study aims to contribute to the optimization of rehabilitation protocols for oncology patients and to provide a scalable model for integrating digital health solutions into routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single Blind (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years.
- •Participants who understand Spanish.
- •Patients scheduled for colorectal cancer surgery at Royo Villanova Hospital, Zaragoza, Spain.
- •Patients attending the first consultation in the General and Digestive Surgery Section under the supervision of Dr. Blas, head of surgery at Royo Villanova Hospital, Zaragoza, Spain.
- •Participants with functional independence that allows them to perform walking and pulmonary function tests.
- •Patients with a preoperative assessment score of I, II, or III on the American Society of Anesthesiologists (ASA) scale.
- •Participants who agree to participate and sign the informed consent form.
排除标准
- •Patients older than 80 years.
- •Patients with a preoperative ASA score of IV.
- •Patients with any injury, pathology, or inflammatory processes that make it impossible to practice exercise.
- •Patients with central and/or peripheral neurological diseases that prevent them from following the rehabilitation program.
- •Patients with unstable cardiac comorbidities such as arrhythmias, high blood pressure, angina pectoris, or other conditions that contraindicate moderate-intensity training.
- •Patients diagnosed with a psychiatric disorder as confirmed by a psychiatrist.
- •Patients without access to mobile internet or a computer with internet at home.
- •Patients who score ≤ 24 on the Mini-Mental State Examination (MMSE).
- •Individuals who are unable to follow oral and written instructions in Spanish.
- •Patients who refuse to participate in the study or who have not signed the informed consent form.
研究组 & 干预措施
Control Group. Booklet-based rehabilitation
Receive a booklet-based rehabilitation program at home through a detailed printed guide (explanatory booklet).
干预措施: Booklet-based rehabilitation program (Other)
Intervention Group. Asynchronous telerehabilitation
Receive a home-based rehabilitation program via an asynchronous digital telerehabilitation platform.
干预措施: Telerehabilitation Program (Other)
结局指标
主要结局
Functional Capacity - Six Minute Walking Test (6MWT)
时间窗: Functional capacity will be assessed at four time points: pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).
The primary outcome is the improvement in functional capacity, which will be evaluated using the Six Minute Walking Test (6MWT). This test measures the maximum distance a patient can walk in six minutes along a flat, straight corridor under controlled conditions. The results provide an objective assessment of the patient\'s functional capacity, reflecting their ability to perform daily activities and their level of postoperative recovery.
次要结局
- Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)(Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).)
- Adherence to the Tele-Rehabilitation Program(Monitored continuously throughout pre-intervention (T1) - the day before surgery (T2), 21 days post-surgery (T3) - 50 days post-surgery (T4).)
- Pulmonary Capacity - Spirometry Assessments(Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).)
- Upper Limb Muscle Strength - Hand Grip Test(Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).)
- Lower Limb Muscle Strength - Sit to Stand Test(Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).)
- Body Composition - Bioelectrical Impedance Analysis and Waist-to-Hip Ratio(Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).)
- Postoperative Complications - Comprehensive Complication Index (CCI)(Evaluated 3 months post-surgery (T5).)
- Quality of Life - EuroQol-5D (EQ-5D)(Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).)
- Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS)(Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).)
- Psychological Adjustment - Mental Adjustment to Cancer Scale (MAC)(Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).)
- Satisfaction with Tele-Rehabilitation Program(Monitored continuously throughout pre-intervention (T1) - the day before surgery (T2), 21 days post-surgery (T3) - 50 days post-surgery (T4).)
- Incremental Cost-Effectiveness Ratio (ICER) - Cost per QALY(Evaluated after 3 months post-surgery (T5).)
- Quality-Adjusted Life Years (QALYs)(Evaluated after 3 months post-surgery (T5).)
研究者
Sandra Calvo Carrión
PhD
Instituto de Investigación Sanitaria Aragón