Clinical trial NCT03958019: Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer
Official title: Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (RESTORE II) - A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oesophageal Cancer
Gastric Cancer
Liver Cancer
Pancreatic Cancer
Keywords: Rehabilitation
Exercise
Diet
Education
Survivor-ship
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Health Research Board, Ireland
name: St. James's Hospital, Ireland
name: St Vincent's University Hospital, Ireland
name: Tallaght University Hospital
First posted: 2019-05-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Convergent parallel mixed methods design
Primary purpose: TREATMENT

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.

Detailed description: Curative treatment for upper gastrointestinal (UGI) cancers is associated with numerous side-effects including sarcopenia and nutritional compromise, increasing morbidity, compromising functional capacity and decreasing health-related quality of life (HR-QOL) in survivorship. As survival improves in UGI cancer, there is increasing focus on optimizing survivorship, however research examining rehabilitation programs in this newly-emergent complex clinical cohort is lacking.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Ongoing serious post-operative morbidity
* Evidence of active or recurrent disease
* Co-morbidities that would preclude safe exercise participation;

Primary outcomes:
measure: Change in Cardiorespiratory Fitness from Baseline
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Secondary outcomes:
measure: Physical Performance
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
measure: Lower Limb Muscle Strength
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
measure: Hand Grip Strength
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
measure: Physical Activity
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
measure: Body Mass Index
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
measure: Waist Circumference
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
measure: Mid Arm Circumference
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
measure: Fat Mass
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
measure: Fat Free Mass
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
measure: Skeletal Muscle Mass
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
measure: Dietary Quality
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
measure: Health Related Quality of Life
timeFrame: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
measure: Health Related Quality of Life (Specific to Oesophago-gastric cancer)
timeFrame: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
measure: Health Related Quality of Life (Specific to Hepatocellular carcinoma)
timeFrame: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
measure: Health Related Quality of Life (Specific to Pancreatic carcinoma)
timeFrame: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
measure: Fatigue
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
measure: Qualitative Approach
timeFrame: Immediately after the program intervention and Three-months post intervention
measure: Cost Analysis
timeFrame: Up to 1 year post program completion
measure: Bio-sample Collection
timeFrame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Trinity College
state: Leinster
Study officials:
affiliation: Professor in Physiotherapy
name: Juliette Hussey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.