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Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (RESTORE II)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Oesophageal Cancer Gastric Cancer Liver Cancer Pancreatic Cancer | Other: RESTORE II Program | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Convergent parallel mixed methods design |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | Study outcomes will be assessed by a blinded assessor. |
| Primary Purpose: | Treatment |
| Official Title: | Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (RESTORE II) - A Randomised Controlled Trial |
| Estimated Study Start Date : | January 1, 2021 |
| Estimated Primary Completion Date : | June 1, 2023 |
| Estimated Study Completion Date : | December 1, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Other: RESTORE II Program
Detailed in arm description
|
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No Intervention: Control
Usual care control group
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- Change in Cardiorespiratory Fitness from Baseline [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
- Physical Performance [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]Physical Performance will be measured with the Short Physical Performance Battery (SPPB)
- Lower Limb Muscle Strength [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]Lower limb muscle strength (llbs)will be measured by a leg press 1-RM
- Hand Grip Strength [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]Hand grip strength (kg) will be measured with hand held dynamometry
- Physical Activity [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]Physical Activity levels will be measured by accelerometry (ACTIGRAPH GT3X+)
- Body Mass Index [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]Body mass index will be measured as the ratio of weight (kg) to height in metres squared.
- Waist Circumference [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]Waist circumference (cm) will be measured at the mid-point between the iliac crest and the 12th rib following gentle expiration.
- Mid Arm Circumference [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]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.
- Fat Mass [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]Fat mass(kg) will be measured with the Seca mBCA 515.
- Fat Free Mass [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]Fat free mass (kg) will be measured with the Seca mBCA 515.
- Skeletal Muscle Mass [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]Skeletal muscle mass(kg) will be measured with the Seca mBCA 515.
- Dietary Quality [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]Dietary quality will be scored using the WCRF/AICR index which determines adherence to healthy eating guidelines for cancer survivors.
- Health Related Quality of Life [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3) ]
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.
- Health Related Quality of Life (Specific to Oesophago-gastric cancer) [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3) ]
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.
- Health Related Quality of Life (Specific to Hepatocellular carcinoma) [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3) ]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.
- Health Related Quality of Life (Specific to Pancreatic carcinoma) [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), Three month Follow-up (T2), One-year post intervention (T3) ]
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.
- Fatigue [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]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.
- Qualitative Approach [ Time Frame: Immediately after the program intervention and Three-months post intervention ]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.
- Cost Analysis [ Time Frame: Up to 1 year post program completion ]The costs of the program will be set against the effects on HRQOL
- Bio-sample Collection [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ]Serum and Plasma samples will be collected at each time-point to establish a survivorship Biobank for UGI cancer.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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;
| Contact: Linda O'Neill, PhD | +35318964809 | oneilll8@tcd.ie | |
| Contact: Emer Guinan, PhD | +35318964125 | guinane1@tcd.ie |
| Ireland | |
| Trinity College | |
| Dublin, Leinster, Ireland, D08 W9RT | |
| Contact: Linda O'Neill, PhD +35318964809 oneilll8@tcd.ie | |
| Principal Investigator: | Juliette Hussey, PhD | Professor in Physiotherapy |
| Tracking Information | |||||||||
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| First Submitted Date ICMJE | April 2, 2019 | ||||||||
| First Posted Date ICMJE | May 21, 2019 | ||||||||
| Last Update Posted Date | October 26, 2020 | ||||||||
| Estimated Study Start Date ICMJE | January 1, 2021 | ||||||||
| Estimated Primary Completion Date | June 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in Cardiorespiratory Fitness from Baseline [ Time Frame: Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2) ] Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer | ||||||||
| Official Title ICMJE | Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (RESTORE II) - A Randomised Controlled Trial | ||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Convergent parallel mixed methods design Masking: Single (Outcomes Assessor)Masking Description: Study outcomes will be assessed by a blinded assessor. Primary Purpose: Treatment
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| Condition ICMJE |
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| Intervention ICMJE | Other: RESTORE II Program
Detailed in arm description
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
120 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 1, 2023 | ||||||||
| Estimated Primary Completion Date | June 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Ireland | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03958019 | ||||||||
| Other Study ID Numbers ICMJE | HRB-DIFA RESTORE II Trial | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Prof Juliette Hussey, University of Dublin, Trinity College | ||||||||
| Study Sponsor ICMJE | University of Dublin, Trinity College | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University of Dublin, Trinity College | ||||||||
| Verification Date | October 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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