Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2014-10-31
2017-06-30
Brief Summary
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Detailed Description
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Outcomes The primary outcome across both Phase I and Phase II is functional capacity. Secondary outcomes including inflammatory status, energy metabolism and nutritional status will be measured as appropriate during the study. All outcomes are discussed in detail elsewhere.
Phase I: Longitudinal Study Examining the impact of progressive cachexia, dysmetabolism and cancer treatment on functional capacity in OC patients
Phase I will be designed as a longitudinal analysis, commencing at the time of diagnosis, tracking the progression of cachexia and associated dysmetabolic state, incorporating inflammatory profiles, energy metabolism (oxidative phosphorylation and glycolysis) and gut hormones, throughout treatment for OC and examining the impact of this decline on measures of physical functioning. Assessments will be completed at diagnosis (T0), cycle 2 chemotherapy (T1), cycle 3 chemotherapy (T2), pre-oesophagectomy (T3), post-oesophagectomy (T4), 4-weeks post-surgery (T5) and six months post-surgery (T6). All assessments will be completed during the same day as routine out-patient appointments thereby reducing the burden on participants. Furthermore, blood samples will be taken during routine clinical sampling and CT scans will be completed as part of routine medical care.
Phase II: Randomised Controlled Trial Can rehabilitation following curative treatment for OC optimise health-related functional outcomes?
Phase II will examine the effect of a 12-week rehabilitation programme, incorporating a walking intervention, individualised nutritional advice and education session, on functional status following curative treatment for OC. Following completion of Phase I and medical clearance to progress to Phase II, participants will be randomised 1:1 to either the intervention group or a control group. The control group will not receive the intervention however following completion of final assessments, participants will be offered an individual exercise and dietary session with the research physiotherapist and dietitian. During the intervention period, participants in the control group will continue to receive routine medical care.
The primary outcome for the multidisciplinary rehabilitation programme will be a change in functional capacity as measured by aerobic capacity. Secondary measures of functional capacity will include a stair climbing test, hand grip and physical activity. Body composition will also be measured by bio impedance analysis. The secondary outcomes that will be assessed are nutritional status, dietary quality and healthy related quality of life (QOL). Inflammatory profiles, measures of energy metabolism and gut hormones are unlikely to be influenced by the proposed rehabilitative intervention and therefore will not be measured. Assessments will be completed at, programme completion and three months post programme completion. Assessments take place at the Welcome Trust-HRB Clinical Research Facility St. James's Hospital. The rehabilitation programme will consist of three main components; 1. Exercise session, 2. Dietary sessions and 3. Education sessions. The intervention outlined below is devised based best evidence, pilot data and clinical expertise. The design final design will be informed form the results of the feasibility study and from needs identified in Phase I.
Exercise Sessions The exercise component of the rehabilitation programme will take the form of a 12 week supervised and home-based walking intervention. A walking intervention was chosen as walking is the most common form of exercise completed by adults nationally and worldwide, it is safe and feasible for deconditioned cohorts and represents a functionally meaningful activity. The feasibility of implementing a similar programme in cancer survivors has been previous established.
Group walking sessions will be supervised twice weekly during the first four weeks of the programme to re-introduce exercise to participant's lives in a safe and structured manner. As the programme progresses the frequency of supervised sessions will decrease to increase participants independence with the protocol. In the absence of guidance on appropriate exercise prescription in cancer cohorts, exercise intensity will be prescribed in accordance with the American College of Sports Medicine (ACSM) guidelines for exercise in deconditioned populations (28). Initially, activity will be prescribed at a light intensity and will progress during the programme to a moderate aerobic intensity. The proposed starting intensity is based on pilot data from the investigators institute suggesting that aerobic fitness levels are either 'poor' or 'very poor' in the early post-treatment phase. Participants will wear Polar Heart Rate monitors during all sessions to ensure compliance with the exercise prescribed. The goal at programme completion will be participation in 30 minutes of moderate intensity activity five days per week, as per the ACSM physical activity guidelines.
Nutrition Sessions Nutrition sessions will be delivered during week 1, week 2 and then fortnightly on a one to one basis. Weight and circumferential measures will be recorded at each session and dietary intake will be assessed as described previously.
The education delivered in the nutrition sessions will be individualised to participants needs. There is limited knowledge of the specific nutritional needs of oesophageal cancer survivors. Based on experience at this centre, the investigators anticipate that a heterogeneous mix of dietary issues requiring intervention will present in this cohort. These include persistent weight loss, anorexia, gastrointestinal disturbance and altered bowel habit. In addition, participants may require specific dietary advice to reduce the risk of other diseases e.g. cardio-protective dietary advice. Furthermore, the increase in physical activity by participants throughout the intervention will require dietary monitoring and advice to avoid inappropriate negative energy balance.
The feasibility study will assist in identifying specific nutritional issues facing oesophageal cancer survivors and help inform content and delivery of the nutrition education sessions. The target for participants is optimal dietary intake in line with the WCRF guidelines for cancer survivors. Supporting literature detailing prescriptive dietary advice will be developed and provided to participants.
Education Sessions Education sessions will be delivered weekly during weeks 1-4 and fortnightly thereafter by a range of members of the multidisciplinary team. As per the cardiac rehabilitation model, education sessions will talk place after the exercise session and cool-down, to monitor participant recovery following exercise. Education topics covered by the physiotherapist will include advice regarding physical activity guidelines, discouraging sedentary behaviour and overcoming barriers to physical activity. The dietitian will discuss dietary management of gastrointestinal symptoms and will also educate participants on healthy eating for cancer survivors as per World Cancer Research Fund, including practical advice and strategies to achieve dietary goals. Participants will be encouraged to highlight topics that may be of particular concern to them for discussion. As per the cardiac rehabilitation model, such topics may be covered by members of the multi-disciplinary team including the surgeon, gastrointestinal nurse, occupational therapist or social worker. Education sessions will take place at the Welcome Trust-HRB Clinical Research Facility St. James's Hospital.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Rehabilitation Programme
12 week multi-disciplinary intervention prescribing exercise, individual dietary counselling and education sessions.
Rehabilitation programme
The RESTORE trial is a 12 week multi-disciplinary intervention involving exercise, nutrition advice and education sessions
Control
Usual care control arm
No interventions assigned to this group
Interventions
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Rehabilitation programme
The RESTORE trial is a 12 week multi-disciplinary intervention involving exercise, nutrition advice and education sessions
Eligibility Criteria
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Inclusion Criteria
* Curative treatment intent.
* Age \>18 years
* Able to understand English
Exclusion Criteria
ALL
No
Sponsors
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University College Dublin
OTHER
University of Dublin, Trinity College
OTHER
Responsible Party
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Prof Juliette Hussey
Professor
Principal Investigators
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Juliette Hussey, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Dublin, Trinity College
Locations
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St James's Hospital
Dublin, , Ireland
Countries
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References
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Kennedy SA, Annett SL, Dunne MR, Boland F, O'Neill LM, Guinan EM, Doyle SL, Foley EK, Elliott JA, Murphy CF, Bennett AE, Carey M, Hillary D, Robson T, Reynolds JV, Hussey J, O'Sullivan J. Effect of the Rehabilitation Program, ReStOre, on Serum Biomarkers in a Randomized Control Trial of Esophagogastric Cancer Survivors. Front Oncol. 2021 Sep 15;11:669078. doi: 10.3389/fonc.2021.669078. eCollection 2021.
O'Neill LM, Guinan E, Doyle SL, Bennett AE, Murphy C, Elliott JA, O'Sullivan J, Reynolds JV, Hussey J. The RESTORE Randomized Controlled Trial: Impact of a Multidisciplinary Rehabilitative Program on Cardiorespiratory Fitness in Esophagogastric cancer Survivorship. Ann Surg. 2018 Nov;268(5):747-755. doi: 10.1097/SLA.0000000000002895.
Other Identifiers
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HRA-POR-2014-535
Identifier Type: -
Identifier Source: org_study_id