Clinical trial NCT06593678: Telerehabilitation in Cancer Patients: Optimization of Prehabilitation and Rehabilitation Following Colorectal Resection
Official title: Telerehabilitation in Cancer Patients: Optimization of Prehabilitation and Rehabilitation Following Colorectal Resection. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Telerehabilitation
Physical Therapy
Keywords: Colorectal Cancer
Telerehabilitation
Physical Therapy
Functional Recovery
Multimodal program
Quality of life
Psychosocial factors
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
Collaborators: name: Universidad de Zaragoza
name: Universidad San Jorge
name: Hospital Royo Villanova de Zaragoza
First posted: 2024-09-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, sigle-blind randomized clinical trial with two parallel interventions
Primary purpose: TREATMENT

Brief summary: 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\&amp;#39; 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Functional Capacity - Six Minute Walking Test (6MWT)
timeFrame: 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).
Secondary outcomes:
measure: Pulmonary Capacity - Spirometry Assessments
timeFrame: Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).
measure: Upper Limb Muscle Strength - Hand Grip Test
timeFrame: Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).
measure: Lower Limb Muscle Strength - Sit to Stand Test
timeFrame: Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).
measure: Body Composition - Bioelectrical Impedance Analysis and Waist-to-Hip Ratio
timeFrame: Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).
measure: Postoperative Complications - Comprehensive Complication Index (CCI)
timeFrame: Evaluated 3 months post-surgery (T5).
measure: Quality of Life - EuroQol-5D (EQ-5D)
timeFrame: Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).
measure: Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS)
timeFrame: Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).
measure: Psychological Adjustment - Mental Adjustment to Cancer Scale (MAC)
timeFrame: Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).
measure: Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).
measure: Adherence to the Tele-Rehabilitation Program
timeFrame: Monitored continuously throughout pre-intervention (T1) - the day before surgery (T2), 21 days post-surgery (T3) - 50 days post-surgery (T4).
measure: Satisfaction with Tele-Rehabilitation Program
timeFrame: Monitored continuously throughout pre-intervention (T1) - the day before surgery (T2), 21 days post-surgery (T3) - 50 days post-surgery (T4).
measure: Incremental Cost-Effectiveness Ratio (ICER) - Cost per QALY
timeFrame: Evaluated after 3 months post-surgery (T5).
measure: Quality-Adjusted Life Years (QALYs)
timeFrame: Evaluated after 3 months post-surgery (T5).
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Royo Villanova
Study officials:
affiliation: Universidad de Zaragoza
name: Sandra Calvo, PhD
role: PRINCIPAL_INVESTIGATOR
References: