SLCTR/2020/022.
| Study name | 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 |
| Methods |
Study design: RCT Country: Sri Lanka |
| Participants | Colorectal cancer patients Inclusion criteria: a. male and female; b. above 18 years; c. diagnosed with colorectal cancer and awaiting surgery; d. fit enough to perform planned physical exercise. Exclusion criteria: a. awaiting palliative colorectal surgery; b. undergoing emergency colorectal surgery; c. not fit enough to perform planned physical activities; d. unable to perform the planned physical exercise (e.g.amputees, comorbidities which prevent planned exercise); e. already participating in mindfulness, yoga, or exercises for more than 30 minutes per day. Stated purpose: to study 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 |
| Interventions |
Intervention: Mindfulness‐based trimodal prehabilitation programme The multidisciplinary mindfulness‐based trimodal prehabilitation programme is composed of four elements: 1. exercise programme, 2. nutritional intervention, 3. psychological coping, 4. mindfulness protocol. For Mindfulness Protocol: the mindfulness‐based 4‐week programme 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 well‐being, 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. The intervention will be provided for a period of four weeks only once during the study cycle. Control: Usual care (standard therapy/practice (without mindfulness): the same intervention trimodal prehabilitation (exercise programme, nutritional intervention and psychological coping) will be offered during the prehabilitation (4 weeks) with no component of mindfulness‐based procedure). |
| Outcomes |
Participants'outcomes of interest for this review
Economic outcomes Nil Time points: baseline, post‐intervention (4 weeks after prehabilitation or before the surgery, 4 weeks postoperatively, 8 weeks postoperatively) |
| Starting date | 1 November 2020 |
| Contact information | Prof. Bawantha Gamage, bawantha@sjp.ac.lk |
| Notes |
Source of funding: not specified Prospective trial registration number: SLCTR/2020/022 |