Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer
NCT ID: NCT03958019
Last Updated: 2022-04-13
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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2022-01-25
2024-12-01
Brief Summary
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Detailed Description
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The investigators recently designed, implemented, and evaluated the Rehabilitation Strategies following Oesophagogastric Cancer (RESTORE) program, a novel multidisciplinary rehabilitation program tailored for oesophagogastric cancer survivorship. The feasibility and preliminary efficacy of the RESTORE program was established and there is now recognized need to further examine program efficacy in a definitive trial.
Using a convergent parallel mixed-methods design, RESTORE II, implemented as a 2-armed randomized controlled trial, will examine if multidisciplinary rehabilitation can improve functional capacity and HRQOL in UGI cancer survivors. RESTORE II will prescribe a 12-week program of supervised aerobic and resistance training, self-directed unsupervised exercise, individualized dietetic counselling and multidisciplinary education for patients who are \>3 months following oesophagectomy, gastrectomy, pancreaticoduodenectomy, or major liver resection. A sample of 60 participants per arm will be recruited to establish a mean increase in functional capacity (cardio-respiratory fitness) of 3.5 ml/kg/min with 90% power, 5% significance and 20% drop-out.
Quantitative assessments including cardiopulmonary fitness and functional exercise capacity will be completed at baseline, post-intervention and 3-months post-intervention (Objective 1). HR-QOL will be quantitatively assessed pre and post-intervention, at 3-months post-intervention and 1 year post-enrollment (Objective 2). Impact on physical, mental and social well-being will be qualitatively examined during focus groups immediately post-intervention and 3-months post-intervention (Objective 3). The implementation costs of RESTORE II will be analysed in consideration of clinician salaries, overheads and equipment costs (Objective 4). Bio-samples will be collected pre and post-intervention and 3-months post-intervention, establishing the first National UGI Cancer Survivorship Biobank (Objective 5). A patient centered approach to enhancing trial recruitment in this complex cohort will also be evaluated (Objective 6).
Following this evaluation, the RESTORE II program will provide a unique model of multidisciplinary rehabilitation in nutritionally complex UGI cancer survivors.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention Group
12 week multidisciplinary program consisting of; i) supervised and home-based aerobic and resistance training, ii) 1:1 dietary counselling, and iii) group education sessions.
RESTORE II Program
Detailed in arm description
Control
Usual care control group
No interventions assigned to this group
Interventions
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RESTORE II Program
Detailed in arm description
Eligibility Criteria
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Inclusion Criteria
* Completion of adjuvant oncological therapy
* Successful completion of baseline cardiopulmonary exercise test
* Medical clearance to participate.
Exclusion Criteria
* Evidence of active or recurrent disease
* Co-morbidities that would preclude safe exercise participation;
18 Years
ALL
No
Sponsors
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Health Research Board, Ireland
OTHER
St. James's Hospital, Ireland
OTHER
St Vincent's University Hospital, Ireland
OTHER
Tallaght University Hospital
OTHER
University of Dublin, Trinity College
OTHER
Responsible Party
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Prof Juliette Hussey
Professor Juliette Hussey
Principal Investigators
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Juliette Hussey, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor in Physiotherapy
Locations
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Trinity College
Dublin, Leinster, Ireland
Countries
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Central Contacts
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Facility Contacts
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References
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O'Neill L, Knapp P, Doyle SL, Begic S, Smyth E, Kearney N, Grehan S, Parker A, Browne P, Segurado R, Connolly D, O'Sullivan J, Reynolds JV, Guinan E, Hussey J. Can a Public and Patient Involvement (PPI) Informed Participant Information Leaflet (PIL) Improve Trial Recruitment, Retention, and Quality of Decision Making? Results of a Randomised Controlled Double-Blind Study Within a Trial (SWAT). Health Expect. 2025 Jun;28(3):e70321. doi: 10.1111/hex.70321.
O'Neill L, Murphy F, Reidy D, Poisson C, Hussey J, Guinan E. Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial. HRB Open Res. 2024 Oct 18;6:46. doi: 10.12688/hrbopenres.13763.3. eCollection 2023.
O'Neill L, Knapp P, Doyle SL, Guinan E, Parker A, Segurado R, Connolly D, O'Sullivan J, Reynolds JV, Hussey J. Patient and family co-developed participant information to improve recruitment rates, retention, and patient understanding in the Rehabilitation Strategies Following Oesophago-gastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial: Protocol for a study within a trial (SWAT). HRB Open Res. 2020 Nov 10;2:27. doi: 10.12688/hrbopenres.12950.2. eCollection 2019.
O'Neill L, Guinan E, Doyle S, Connolly D, O'Sullivan J, Bennett A, Sheill G, Segurado R, Knapp P, Fairman C, Normand C, Geoghegan J, Conlon K, Reynolds JV, Hussey J. Rehabilitation strategies following oesophagogastric and Hepatopancreaticobiliary cancer (ReStOre II): a protocol for a randomized controlled trial. BMC Cancer. 2020 May 13;20(1):415. doi: 10.1186/s12885-020-06889-z.
Other Identifiers
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HRB-DIFA RESTORE II Trial
Identifier Type: -
Identifier Source: org_study_id
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