Perioperative Exercise and Nutritional Optimisation Prehabilitation Before Surgery for Patients With Peritoneal Malignancy

N/AActive Not RecruitingNCT05305820

Dublin City University36 enrolled

Overview

People who are diagnosed with cancer of the colon/rectum/appendix/ovaries that spreads into the lining of the tummy and some ovarian cancers or people with pseudomyxoma peritonei can often undergo intensive treatment including major surgery where chemotherapy is given whilst the person is having surgery - also known by doctors as surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Fitness for this surgery can improve if people undertake a prehabilitation programme at the time they get their diagnosis. To date, little research has focused on how exercise and nutrition support before surgery can help these patients during recovery. The aim of this study is to explore the use of exercise and nutritional support pre-treatment to enhance physical and psychological outcomes for patients.

The comparator in this study will be standard oncological care. Control patients will receive the same care as standard without the addition of a formal exercise and nutrition support programme. The pre-treatment (prehabilitation) programme will commence following diagnosis and continue up to the point of surgery and recommence for six weeks following surgery when deemed clinically fit to participate. Assessments will occur at baseline, pre-surgery, post-surgery, and 6 weeks later and a follow up... Mixed methods will be employed with patients taking part in self-report assessments, physical assessments, and qualitative interviews. The primary aim of the study is to assess the feasibility of the intervention and cardiorespiratory fitness pre-surgery. The secondary aims include assessing the effect of the intervention on physical health, psychological wellbeing, health-related quality of life, self-efficacy, nutrition, and serology markers. Exploratory aims also include post-operative morbidity, health economics analysis and qualitative interview of patient experience.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Interventions

ExerciseBEHAVIORAL

Standard Exercise Program- Participants will be invited to take part in a structured home, supervised, or both, exercise program while undergoing treatment and for a six-week period when deemed fit post-surgery.

NutritionBEHAVIORAL

Participants will be screened for their nutritional health and tailored advice and education will be provided on an individualised basis. An online dietary recall tool will be used to track patients' dietary habits. This will occur from diagnosis until point of surgery and recommence for 6 weeks post-surgery once deemed physically fit.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age ≥18 years, * multidisciplinary team referral for CRS-HIPEC for colorectal/appendix/ovarian peritoneal disease or pseudomyxoma peritonei (+/- completed neoadjuvant cancer treatment) * WHO performance status ≤2. Exclusion Criteria: * inability to provide informed consent, * impaired cognitive function with a reduced ability to either understand advice /instructions from or communicate with the research team, * declined surgery, * surgery in less than 2 weeks * pregnancy or breastfeeding, * inability to participate in the exercise training (unable to perform the 6 Minute Walk Test) * absolute contraindications to exercise testing, veganism.

Outcomes

Primary Outcomes

Feasibility of Adherence to the Intervention

Prehabilitation fidelity in terms of the patient group adherence as measured by patient structured qualitative feedback and activity logs.

Time frame: 2-6 weeks pre surgery, 6 weeks post-surgery

Feasibility of participant retention to the Intervention

Prehabilitation fidelity in terms of the patient group retention as measured by patient screening and retention logs and monitoring of recruitment rates.

Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery

Feasibility of intervention effectiveness

Prehabilitation fidelity in terms of intervention effectiveness as measured by qualitative patient feedback at two timepoints. Monitoring of patient activity logs. Engagement with online and in-person exercise and nutritional intervention resources.

Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery

Change in Cardiorespiratory Fitness

Cardiorespiratory fitness using the 6-Minute Walk Test (6MWT) assessed at the pre-surgery time point. The 6MWT is performed with participants walking up and down a 20 m course marked by cones for 6 min under instruction to cover as much ground as possible. The number of laps completed is recorded. A standard set of instructions is used as per the European Respiratory Society guidelines. The 6MWT is a validated assessment of cardiorespiratory function in clinical populations.

Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery

Secondary Outcomes

Change in Strength - The Handgrip Test

This is measured using a hand dynamometer. The test will be conducted in a standing position with the upper arm tight against the participant's trunk and the forearm at a right angle to the upper arm. If this is not possible the participant may sit in an upright chair or use their free hand to rest the dynamometer on a table to support the arm. The gripping handle will be set to a comfortable width to ensure the patient can rest the middle piece of the four fingers on the handle. The participant will be instructed to squeeze the handle with maximum force for a few seconds. The value on the scale will be recorded. The participant will complete two trials on each hand. The highest score will be accepted.

Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery

Change in Strength - The Stand to Sit Test

Participants will sit on a chair (height 43-45 cm) with arms crossed on their, and legs flat on the floor, parallel to each other, and approximately shoulder width apart. Participants will stand up and sit down 10 times as quickly as possible. Participants must not bounce off the chair when moving from a seated position to standing position. They must fully extend their legs on each stand. The time taken to perform 10 repetitions will be timed using a stopwatch. Participants will perform two trials and the best trial will be recorded as their score.

Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery

Change in Activity - 3-day ActivPAL3 triaxial accelerometer

Participants will be instructed to wear the device on the midpoint of the anterior aspect of the right thigh and attach using a film adhesive frame dressing. They will continue to wear this for three days continuously. They cannot wear the ActivPAL3 triaxial accelerometer during water activity periods.

Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery

Change in Psychological Stress

NCCN Distress Thermometer: To detect distress (psychosocial stress) with all stages of cancer. This is measured using a visual analogue scale like a thermometer to indicate a range from 0 (not loaded) to 10 (extreme pressure). Additional 36 items in five problem areas - practical family, emotional, spiritual, physical, are rated for distress and a score of 5 or higher is considered significant stress.

Time frame: 2-6 weeks pre-surgery, 6 weeks post-surgery

Change in Psychological Stress- Impact of Events Scale

This is a self-report measure of traumatic stress symptoms focused on intrusive thoughts and avoidant behaviours. Questions will be adapted to reflect the PM diagnosis specifically. Frequency of symptoms will be self-reported during the previous week using a 4 point scale from 0 (not at all) to 5 (often). Total scores range from 0 to 75 with higher scores indicative of greater cancer-related stress. Scores in the range of \> 30 are reflective of clinically significant stress. Higher scores on an adapted IES are related to decreased immune function in breast cancer patients.