Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593678
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Telerehabilitation in Cancer Patients Optimization of Prehabilitation and Rehabilitation Following Colorectal Resection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Telerehabilitation in Cancer Patients Optimization of Prehabilitation and Rehabilitation Following Colorectal Resection a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCR
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 patientsamp39 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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None