Trial Title:
Telerehabilitation in Cancer Patients: Optimization of Prehabilitation and Rehabilitation Following Colorectal Resection
NCT ID:
NCT06593678
Condition:
Colorectal Cancer
Telerehabilitation
Physical Therapy
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal Cancer
Telerehabilitation
Physical Therapy
Functional Recovery
Multimodal program
Quality of life
Psychosocial factors
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective, sigle-blind randomized clinical trial with two parallel interventions
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
Single Blind (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Telerehabilitation Program
Description:
Participants in the intervention group will receive a home-based rehabilitation program
delivered via an asynchronous digital telerehabilitation platform. The multimodal program
is accessible at online platform and it is composed for therapeutic exercises, including
aerobic and strength training exercises, aimed at improving functional capacity and
quality of life before and after colorectal cancer surgery.
Arm group label:
Intervention Group. Asynchronous telerehabilitation
Other name:
Asynchronous Digital Rehabilitation
Intervention type:
Other
Intervention name:
Booklet-based rehabilitation program
Description:
Participants in the control group will receive a booklet-based rehabilitation program at
home, provided through a detailed printed guide (explanatory booklet). This guide
includes instructions in pictures and text for the multimodal program. It is composed for
therapeutic exercises, including aerobic and strength training exercises, aimed at
improving functional capacity and quality of life before and after colorectal cancer
surgery.
Arm group label:
Control Group. Booklet-based rehabilitation
Other name:
Printed Guide Rehabilitation
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' 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Royo Villanova
Address:
City:
Zaragoza
Zip:
50015
Country:
Spain
Status:
Recruiting
Contact:
Last name:
José Manuel Burgos Bragado, MSc
Phone:
+34 646207142
Email:
jmburgos@usj.es
Start date:
March 12, 2024
Completion date:
July 28, 2025
Lead sponsor:
Agency:
Instituto de Investigación Sanitaria Aragón
Agency class:
Other
Collaborator:
Agency:
Universidad de Zaragoza
Agency class:
Other
Collaborator:
Agency:
Universidad San Jorge
Agency class:
Other
Collaborator:
Agency:
Hospital Royo Villanova de Zaragoza
Agency class:
Other
Source:
Instituto de Investigación Sanitaria Aragón
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06593678
