Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (RESTORE II)

Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (RESTORE II) - A Randomised Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Pancreatic Cancer; Liver Cancer; Oesophageal Cancer
• Intervention / Treatment: Other: RESTORE II Program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda O'Neill, PhD; Phone Number: +35318964809; Email: oneilll8@tcd.ie
• Study Contact Backup: Name: Emer Guinan, PhD; Phone Number: +35318964125; Email: guinane1@tcd.ie

Study Locations

• Ireland
  • Leinster
    • Dublin, Leinster, Ireland, D08 W9RT
      • Recruiting
      • Trinity College
      • Contact: Linda O'Neill, PhD; Phone Number: +35318964809; Email: oneilll8@tcd.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: RESTORE II Program; Detailed in arm description
No Intervention: Control; Usual care control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Performance	Physical Performance will be measured with the Short Physical Performance Battery (SPPB)	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Lower Limb Muscle Strength	Lower limb muscle strength (llbs)will be measured by a leg press 1-RM	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Hand Grip Strength	Hand grip strength (kg) will be measured with hand held dynamometry	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Physical Activity	Physical Activity levels will be measured by accelerometry (ACTIGRAPH GT3X+)	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Body Mass Index	Body mass index will be measured as the ratio of weight (kg) to height in metres squared.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Waist Circumference	Waist circumference (cm) will be measured at the mid-point between the iliac crest and the 12th rib following gentle expiration.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Mid Arm Circumference	Mid Arm circumference (cm) will be measured at the mid-point between the olecranon process of the ulna and the acromion process of the scapula.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Fat Mass	Fat mass(kg) will be measured with the Seca mBCA 515.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Fat Free Mass	Fat free mass (kg) will be measured with the Seca mBCA 515.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Skeletal Muscle Mass	Skeletal muscle mass(kg) will be measured with the Seca mBCA 515.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Dietary Quality	Dietary quality will be scored using the WCRF/AICR index which determines adherence to healthy eating guidelines for cancer survivors.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Health Related Quality of Life	Quality of Life will be determined by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30). Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden.	Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Health Related Quality of Life (Specific to Oesophago-gastric cancer)	For Oesophago-gastric Cancer Patients Quality of Life will be further assessed with the European Organisation for Research and Treatment of Cancer Oesophago-gastric Cancer Subscale the QLQ-OG25. Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden.	Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Health Related Quality of Life (Specific to Hepatocellular carcinoma)	For Liver Cancer Patients Quality of Life will be further assessed with the European Organisation for Research and Treatment of Cancer Core Hepatocellular carcinoma subscale (QLQ-HCC18) Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden.	Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Health Related Quality of Life (Specific to Pancreatic carcinoma)	For Pancreatic Cancer Patients Quality of Life will be further assessed with the European Organisation for Research and Treatment of Cancer Pancreatic cancer Subscale (QLQ-PAN26). Scores are reported on a linear scale from 0-100. A high score on a functional scale indicates greater function. A high score on a symptom scale indicates greater symptom burden.	Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3)
Fatigue	Fatigue will be assessed using the Multidimensional Fatigue Inventory (MFI-20) questionnaire. It is scored from 0-20. A cut off score of >or =13 indicates severe fatigue.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)
Qualitative Approach	Focus groups and interviews will be carried out with participants from the intervention arm to gain their perspectives of the impact of the program on physical and mental well-being.	Immediately after the program intervention and Three-months post intervention
Cost Analysis	The costs of the program will be set against the effects on HRQOL	Up to 1 year post program completion
Bio-sample Collection	Serum and Plasma samples will be collected at each time-point to establish a survivorship Biobank for UGI cancer.	Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2)

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Collaborators: St Vincent's University Hospital, Ireland; Health Research Board, Ireland; St. James's Hospital, Ireland; Tallaght University Hospital
• Investigators: Principal Investigator: Juliette Hussey, PhD, Professor in Physiotherapy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Diet; Education; Survivor-ship
• Other Study ID Numbers: HRB-DIFA RESTORE II Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No