ReStOre@Home: Feasibility study of a virtually delivered 12-week multidisciplinary rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer - study protocol

Abstract

Background: Exercise rehabilitation programmes, traditionally involving supervised exercise sessions, have had to rapidly adapt to virtual delivery in response to the coronavirus disease 2019 (COVID-19) pandemic to minimise patient contacts. In the absence of an effective vaccine, the pandemic is likely to persist in the medium term and during this time it is important that the feasibility and effectiveness of remote solutions is considered. We have previously established the feasibility of the Rehabilitation Strategies following Oesophago-gastric Cancer (ReStOre) intervention - a face to face multidisciplinary rehabilitation programme for upper gastrointestinal (UGI) cancer survivors. This study will examine the feasibility of a virtually delivered 12-week multi-component ReStOre@Home programme. Methods: This single arm feasibility study will recruit 12 patients who have completed curative treatment for oesophago-gastric cancer. Participants will complete the 12-week ReStOre@Home programme consisting of exercise (aerobic and resistance training), 1:1 dietary counselling and group education sessions through virtual delivery. Underpinned by the Medical Research Council (MRC) Framework, feasibility will be determined by recruitment rates, adherence, retention, incidents, and acceptability. Acceptability will be assessed qualitatively through post-intervention interview and the Telehealth Usability Questionnaire. Secondary outcomes will be assessed pre and post-intervention and will include measures of physical performance (cardiopulmonary exercise test, short physical performance battery, hand grip strength, Godin Leisure Time Questionnaire, and body composition), health related quality of life (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) and oesophago-gastric cancer specific subscale (EORTC-QLQ-OG25), fatigue (Multidimensional Fatigue Inventory (MFI-20), and venous blood samples will be collected for the UGI Cancer Survivorship Biobank. Discussion: The ReStOre@Home feasibility study will provide important data regarding the amenability of a multidisciplinary programme designed for UGI cancer survivors to virtual delivery. Trial registration: ClinicalTrials.gov NCT04603339 (26/10/2020)

ReStOre@Home: Feasibility study of a virtually delivered 12-week multidisciplinary rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer - study protocol

“…background medical history, dietary interview and questionnaires will be provided in advance to minimise face to face contact. Written informed consent will be obtained during the baseline assessment (Extended data 17 ). If there are any findings at assessment which indicate that a person is unsafe to exercise, they will not proceed with the intervention phase of the study.…”

“…Interviews will be held via telephone/video-conference call and will be recorded. The discussion guide (Extended data 17 ) will explore recommendations for future delivery of the programme through telehealth and the impact of the programme on overall health and wellbeing. Interview recordings will be transcribed and analysed using thematic analysis 24 .…”

“…Biosample collection . As per the ReStOre II RCT 8 participants will be invited to consent to donating samples to the Upper Gastrointestinal Cancer Survivorship Biobank (Extended data 17 ). Serum, plasma, and whole blood samples will be collected from consenting participants at T0 and T1.…”

“…During the assessment in the CRF participants will be required to don a mask and clean their hands upon arrival and research staff will don appropriate PPE including a facemask, and goggles, and maintain physical distancing as much as possible. As the intervention will be delivered completely in participants homes, participants will be provided with the ReStOre@Home Exercising at Home Advice Sheet (Extended data 17 ) educating them on normal and abnormal responses to exercise and what they should do if they experience an abnormal response.…”

Patient Experiences of a Telehealth Multidisciplinary Cancer Rehabilitation Programme: Qualitative Findings from the ReStOre@Home Feasibility Study

“…However, it was unknown how well a multidisciplinary rehabilitation programme, involving multiple components and a variety of sessions, would adapt to an online delivery model. To investigate the feasibility of an online model of the ReStOre programme, we converted the ReStOre II protocol to a model of online delivery, titled ReStOre@Home [24].…”