Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer
RESTORE II
1 other identifier
interventional
120
1 country
1
Brief Summary
The RESTORE II randomized controlled trial will examine the efficacy of a 12 week multidisciplinary rehabilitation program consisting of supervised and home-based exercise,1:1 dietetic counselling, and group education sessions for survivors of upper gastrointestinal cancer, namely cancers of the oesophagus, stomach, pancreas, and liver.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedStudy Start
First participant enrolled
January 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedApril 13, 2022
April 1, 2022
2.4 years
April 2, 2019
April 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Cardiorespiratory Fitness from Baseline
Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary Outcomes (19)
Physical Performance
Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Lower Limb Muscle Strength
Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Hand Grip Strength
Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Physical Activity
Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Body Mass Index
Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
- +14 more secondary outcomes
Study Arms (2)
Intervention Group
EXPERIMENTAL12 week multidisciplinary program consisting of; i) supervised and home-based aerobic and resistance training, ii) 1:1 dietary counselling, and iii) group education sessions.
Control
NO INTERVENTIONUsual care control group
Interventions
Eligibility Criteria
You may qualify if:
- Patients \>3-months post oesophagectomy, total gastrectomy, pancreaticoduodenectomy or major liver resection +/- neo-adjuvant/adjuvant chemo/chemoradiotherapy with curative intent
- Completion of adjuvant oncological therapy
- Successful completion of baseline cardiopulmonary exercise test
- Medical clearance to participate.
You may not qualify if:
- Ongoing serious post-operative morbidity
- Evidence of active or recurrent disease
- Co-morbidities that would preclude safe exercise participation;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Dublin, Trinity Collegelead
- Health Research Board, Irelandcollaborator
- St. James's Hospital, Irelandcollaborator
- St Vincent's University Hospital, Irelandcollaborator
- Tallaght University Hospitalcollaborator
Study Sites (1)
Trinity College
Dublin, Leinster, D08 W9RT, Ireland
Related Publications (4)
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.
PMID: 40485109DERIVEDO'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.
PMID: 39280895DERIVEDO'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.
PMID: 33392438DERIVEDO'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.
PMID: 32404096DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juliette Hussey, PhD
Professor in Physiotherapy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Study outcomes will be assessed by a blinded assessor.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Juliette Hussey
Study Record Dates
First Submitted
April 2, 2019
First Posted
May 21, 2019
Study Start
January 25, 2022
Primary Completion
June 1, 2024
Study Completion
December 1, 2024
Last Updated
April 13, 2022
Record last verified: 2022-04