Home » Trials » SLCTR/2020/022
Impact of Mindfulness-based Trimodal Prehabilitation on functional recovery and selected surgical outcomes of patients with Colorectal Cancer admitted to Surgical Professorial unit of Colombo South Teaching Hospital Sri Lanka; A randomised control trial
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SLCTR Registration Number
SLCTR/2020/022
Date of Registration
The date of last modification
Jan 29, 2024
Scientific Title of Trial
Impact of Mindfulness-based Trimodal Prehabilitation on functional recovery and selected surgical outcomes of patients with Colorectal Cancer admitted to Surgical Professorial unit of Colombo South Teaching Hospital Sri Lanka; A randomised control trial
Public Title of Trial
Impact of Mindfulness-based Trimodal Prehabilitation on functional recovery, nutritional status, biochemical markers and psychological markers of patients with colorectal cancer admitted to the Surgical Professorial unit of Colombo South Teaching Hospital, Sri Lanka - A randomized controlled trial
Disease or Health Condition(s) Studied
Colorectal Cancer
Scientific Acronym
None
Public Acronym
None
Brief title
Impact of Mindfulness-based Trimodal Prehabilitation on functional recovery and selected surgical outcomes of Colorectal Cancer patients
Universal Trial Number
U1111-1252-6853
Any other number(s) assigned to the trial and issuing authority
FMC/ USJP ERC 29/19: ERC USJ
What is the research question being addressed?
What impact would mindfulness have on functional recovery, nutritional status, biochemical markers and psychological markers of patients with colorectal cancer receiving Trimodal Prehabilitation admitted to Surgical Professorial unit of Colombo South Teaching Hospital Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Study setting- The study will be conducted at the Surgical Professorial Unit of Colombo South Teaching Hospital.
Method of randomization- • Following consent, participants will be randomized 1:1 using a random number table to the intervention group or control group with stratification by gender and age group.
•The research associate (who will be responsible for patient consent) will be blinded to group allocation.
Description of mindfulness based tromodal prehabilitation intervention
• The multidisciplinary Mindfulnes-Based trimodal prehabilitation program is composed of four (04) elements: 1. Exercise program 2. Nutritional intervention 3. Psychological coping 4. Mindfulness Protocol
• The exact interventions are described in detail below:
Exercise program • Patients will be asked to perform unsupervised exercises 4 days a week for 30 minutes per session. • The exercise regime will comprise of 5 min warm-up exercises, 20 min aerobic exercises and 5 min cool down exercises. • A personalized trainer will evaluate the patient and after discussing with the patient and their families will come up with an individualized exercise plan for the patients based on their physical capacity and resources. • They will also be given a DVD containing videos of the exercises performed by a trained personal giving instruction to the patient to follow. • Patients will be given a chart to fill once completing their exercise regime daily.
Nutrition intervention • The patients enrolled in the prehabilitation program will be evaluated by a qualified nutritionist during the first visit, Aasubjective global assessment will be used to assess each patients’ nutritional status and requirements and an appropriate diet based on the nutritional status of each patient will be prescribed. • The patients will also be provided with whey protein, which will be used as a nutritious food supplement to guarantee a daily intake of 1.2 g/kg body weight of protein. • Patients will be requested to consume protein preferably within 1 h of their exercise regimen according to a specified recipes and an individual dietary.
Psychological Coping • All patients in both groups will be given instructions on relaxation and breathing techniques by a trained practitioner. • An instruction CD will be given for relaxation techniques at home. • Patients will be contacted by the investigator by phone for psychological support will be provided with required training on relaxation and breathing techniques.
Mindfulness Protocol • The Mindfulness-based 4-weeks program will be delivered during the prehabilitation process for the intervention group. • A trained mindfulness practitioner will explain the basic concepts and significance of mindfulness practice for patient wellbeing, guide patients on mindful walking and mindful sitting. • An instruction CD with every session, which they can use for practice of mindfulness at home will be given • For psychological support, the intervention group will be contacted by the investigator over the telephone.
Frequency and duration of intervention • The intervention will be provided for a period of four weeks only once during the study cycle.
Description of prehabilitation received by control group • The same intervention tri-modal prehabilitation ((Exercise program, Nutritional intervention and Psychological coping) will be offered during the prehabilitation (4 weeks) with no component of mindfulness-based procedure to the control group.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
Functional recovery using the Six-Minute Walk Test (6MWT, Pulse Rate (PR), Blood Pressure (BP) and Oxygen Saturation (SpO2) |
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Secondary outcome(s)
1.
Nutritional status will be assessed using 1. Malnutrition Universal Screening Tool (MUST) 2. Body Mass Index (BMI) 3. Serum albumin level 4. Heamoglobin level. (Hb) (<35g/l and Hb - <10g/dl respectively will define poor nutritional status) |
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2.
Psychological assessment will be done using 1. The Hospital Anxiety and Depression Scale (HADS) 2. Mindful Awareness Attention Score (MAAS) 3. Perceived Stress Scale 4. Quality of life (WHOQOL-BREF) questionnaire |
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3.
Biomarker assessment will be done by measuring 1. Salivary α-amylase 2. Serum β-endorphin 3. Serum Cortisol 4. Interleukin-6 (IL – 6) 5. Tumor necrosis factor-alpha (TNF – α) 6. Brain-derived neurotrophic factor (BDNF) 7. Total Antioxidant Capacity (TAC) 8. Reactive Oxygen Species (ROS) level |
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Target number/sample size
150 (75 in one arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2020-11-01
Anticipated end date
2022-05-31
Date of first enrollment
2022-04-20
Date of study completion
Recruitment status
Recruiting
Funding source
University of Sri Jayewardenepura
Regulatory approvals
Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura
Status
Approved
Date of Approval
2020-01-27
Approval number
FMC/ USJP ERC 29/19
Details of Ethics Review Committee
Name: | Ethics Review Committee of the Faculty of Medical Sciences, University of Sri Jayawardanepura. |
Institutional Address: | Faculty of Medical Sciences, University of Sri Jayewardenepura |
Telephone: | +94-11-2758588 |
Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. Bawantha Gamage
Professor in Surgery and Head
Department of Surgery, Faculty of Medical Sciences, University of Sri Jayewardenepura
+94 11 2758660
+94 71 8312897
+94 11 2801480
bawantha@sjp.ac.lk
http://medical.sjp.ac.lk/index.php/surgery-staff
Contact Person for Public Queries
Prof. Bawantha Gamage
Professor in Surgery and Head
Department of Surgery, Faculty of Medical Sciences, University of Sri Jayewardenepura
+94 11 2758660
+94 71 8312897
+94 11 2801480
bawantha@sjp.ac.lk
http://medical.sjp.ac.lk/index.php/surgery-staff
Primary study sponsor/organization
University of Sri Jayewardenepura
University of Sri Jayewardenepura, Gangodawila, Nugegoda
0112 801 025
+94 11 2801604
info@sjp.ac.lk
https://www.sjp.ac.lk/about/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results