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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

23 Oct 2020

The date of last modification

Nov 09, 2020



Application Summary


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


Trial Details


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

  • Male and female
  • Above 18 years
  • Diagnosed with colorectal cancer and awaiting surgery
  • Patients fit enough to perform planned physical exercise

Exclusion criteria

  • Patients who are awaiting palliative colorectal surgery
  • Patients undergoing emergency colorectal surgery
  • Patients who are not fit enough to perform planned physical activities
  • Patients unable to perform the planned physical exercise (E.g.: Amputees, Cormorbities which prevent planned exercise
  • Patients already participating in mindfulness, yoga, or exercises for more than 30 minutes per day


Primary outcome(s)

1.

Functional recovery using the Six-Minute Walk Test (6MWT, Pulse Rate (PR), Blood Pressure (BP) and Oxygen Saturation (SpO2)

[
  1. At the start of the trial
  2. Four weeks after prehabilitation or Before the surgery
  3. 4-Weeks post-operatively
  4. 8-Weeks post-operatively
]

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)

[
  1. At the start of the trial
  2. Four weeks after prehabilitation or before the surgery
  3. 4-Weeks post-operatively
  4. 8-Weeks post-operatively
]
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

[
  1. At the start of the trial
  2. Four weeks after prehabilitation or before the surgery
  3. 4-Weeks post-operatively
  4. 8-Weeks post-operatively
]
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

[
  1. At the start of the trial
    1. Four weeks after prehabilitation or before the surgery
    2. 4-Weeks post-operatively
    3. 8-Weeks post-operatively
]

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


Date of study completion


Recruitment status

Pending


Funding source

University of Sri Jayewardenepura


Regulatory approvals

Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura



State of Ethics Review Approval


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 & Sponsor Information


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/

Secondary study sponsor (If any)







Trial Completion details


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