- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07376668
Effects of a WhatsApp-assisted Prehabilitation for Patient Undergoing Elective Colorectal Cancer Surgery
WhatsApp-assisted Prehabilitation Programme for Adult Patient Undergoing Elective Colorectal Cancer Surgery - A Randomised Controlled Trial
The goals of this study is to evaluate the feasibility and the effects of a WhatsApp-assisted prehabilitation for colorectal cancer patients undergoing elective surgery. The main questions are: If the digital prehabilitation is feasible and acceptable by the colorectal cancer patient prior to elective surgery? If this prehabilitation helps to improve the postoperative complications, length of stay, physical activity and psychological well-being for colorectal cancer patients receiving surgery.
Researcher will compare the prehabilitation plus standard care to standard care only to see if the prehabiliation helps the colorectal cancer patients.
Participants will: 1) enrolled in a approximate 4 weeks (3 episodes/ week) prehabilitation program containing educational information of colorectal cancer, dietary advice, exercises training and psychological podcasting. 2) will answer the survey weekly and after surgery. 3) keep the standard care as per department guidelines
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Colorectal cancer ranks the second most prevalent forms of cancer in Hong Kong and surgery is still the primary curative option. Although compromising result of shorten general length of stay (LOS) in enhanced recovery after surgery (ERAS) protocol is illustrated, surgical complications such as postoperative ileus (POI) remain unresolved and significant burden associated leads to suboptimal patients' outcomes of prolonged LOS and physical deconditioning with extended rehabilitation. Prehabilitation refers to optimization in a single or multi-disciplinary approach of exercises training, nutritional therapy and psychological counselling, improves physical fitness, strengthens cardiopulmonary function and reduce mental distress through lifestyle modification and better physiological reserve. However, the concept of educations in form of preoperative exercises and nutritional counselling outweighs the purposes of actual prehabilitation and short-handed allied health professionals limited accessibility of regular out-patient counselling in the current clinical practices. Consequently, poor adherence to these preoperative trainings may result in to poor surgical outcomes.
A single with assessor-blinded, double-armed randomised controlled trial study with a prior pilot will be employed to examine the feasibility and effects of a technology-assisted prehabilitation for patients with colorectal cancer surgery. Outcomes of postoperative complications, LOS, physical activity, nutritional status, gastrointestinal recovery and psychological well-being will be evaluated. Elective colorectal cancer surgery patient will be invited to participated in this study.
The result will provide insights of the use of digital approach. To our knowledge, this is the very first trial of digital prehabilitation for CRC patients in Hong Kong public hospitals. Therefore, it provides positive contribution and acts as an important quality benchmark for patients' outcomes. The findings will also generate knowledge on the optimalization of care provided to CRC patients prior to surgery and assist to develop a structured and effective health system in our community. This innovation may have implications to other research studies and extends the potential clinical practices to related subspecialities such as gastric cancer.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: SHERING SUNG
- Phone Number: 85222080980
- Email: sheringsung@link.cuhk.edu.hk
Study Locations
-
-
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Hong Kong, Hong Kong
- Tseung Kwan O Hospital
-
Contact:
- SHERING SUNG
- Phone Number: 85222080980
- Email: sheringsung@link.cuhk.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diagnosis of colorectal-related cancer
- scheduled for elective colorectal cancer surgery as primary treatment
- aged 18 years or above
- expected surgery date more than 21 days
- able to collaborate in the study and sign the informed consent
- able to use WhatsApp application
Exclusion Criteria:
- identified or known premorbid, that inability to follow the programme
- able to understand written and spoken Cantonese/ Chinese
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard care
|
|
|
Experimental: WhatsApp-assisted prehabilitation
Patient will receive WhatsApp-assisted prehabilitation plus standard care
|
Standard care as per department guidelines with ERAS protocol (including smoking cessation program, preoperative counselling, early rehabilitation program)
In addition to standard care, participants will receive digital approach of WhatsApp-assisted prehabilitation programme and then start the home-based training for about 3-4 weeks prior to the surgery.
The WhatsApp-assisted prehabilitation includes exercises training, dietary advice and psychological support.
Contents will contain elements of physical training (e.g.
aerobic and resistance exercises) and psychological therapy (e.g.
meditation) will be delivered through WhatsApp at three sessions (day 1, 3 & 5) per week for 30 minutes and 15 minutes respectively, educational information associated with colorectal cancer surgery and prehabilitation(e.g.
high risks factors towards surgical complications) and dietary advices (e.g.
recipes) will be delivered on weekly
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative complications
Time Frame: Postoperative period: assessed up to first year postoperative
|
measured by the Comprehensive Complication Index (CCI), which integrates in a single formula all complications by severity, ranging from 0 (uneventful course) to 100 (death).
|
Postoperative period: assessed up to first year postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of hospital stay (LOS)
Time Frame: Postoperative period: assessed up to the first year postoperative
|
to evaluate the length of postoperative hospital stay
|
Postoperative period: assessed up to the first year postoperative
|
|
Gastrointestinal recovery
Time Frame: Postoperative period: assessed up to 30 days postoperative
|
measured as time to first flatus (in hours)
|
Postoperative period: assessed up to 30 days postoperative
|
|
Gastrointestinal function
Time Frame: Postoperative period: assess up to 30 days postoperative
|
measured as time to first bowel (hours)
|
Postoperative period: assess up to 30 days postoperative
|
|
Anxiety and depression
Time Frame: Assessments at baseline and on the day of discharge: assess up to first year postoperative
|
assessed by the Chinese version of Hospital Anxiety and Depression Scale (C-HADS), a 14-question measure with seven items each for depression and anxiety.
HADS generates separate scores for anxiety and depression as well as a combined score of psychological distress.
Continuos variable 0-21 (0-7 normal value, 11-21 anxiety/depression), higher value from baseline will represent a worse outcome.
|
Assessments at baseline and on the day of discharge: assess up to first year postoperative
|
|
Quality of health-related life
Time Frame: Assessments at baseline and on the day of discharge: assess up to first year postoperative
|
evaluated by the Short Form 12 Health Survey (SF-12 version 2 (Hong Kong)), with Physical Component Summary (PCS) and Mental Component Summary (MCS).
Scores range from 0-100 for the 8 underlying health domains, with higher scores meaning better Health-Related Quality of Life (HRQoL)
|
Assessments at baseline and on the day of discharge: assess up to first year postoperative
|
|
Physical activity
Time Frame: Assessments at baseline, weekly before the surgery and on the day of discharge: assess up to first year postoperative
|
measured by the International Physical Activity Questionnaire Short Form (IPAQ-SF), seven items were assessed in frequency and duration over the past seven days, categorizing it into four types: vigorous intensity, moderate intensity, walking, and sitting.
An average metabolic equivalents score (MET, min·w-1) was calculated to assess total physical activity as well as for each type of activity, separately.
For walking activities, all types of walking were included and an average MET score was derived.
The same procedure was carried out for medium intensity and high intensity activities.
By calculating the number of activity days multiplied by the average duration per activity, statements about the energy consumption per week and the fitness level can be derived.
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Assessments at baseline, weekly before the surgery and on the day of discharge: assess up to first year postoperative
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to the prehabilitation
Time Frame: From enrollment to the completion of study up to 18 months
|
percentage of completed at least 75% of the prehabilitation.
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From enrollment to the completion of study up to 18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: SHERING SUNG, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Pathological Conditions, Signs and Symptoms
- Colorectal Neoplasms
- Disease
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Investigative Techniques
- Therapeutics
- Surgical Procedures, Operative
- Quality of Health Care
- Quality Indicators, Health Care
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Exercise
- Perioperative Care
- Methods
- Standard of Care
- Preoperative Exercise
Other Study ID Numbers
- CIRB-2025-099-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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