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
100 participants
INTERVENTIONAL
2021-03-12
2022-12-15
Brief Summary
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Detailed Description
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To do so, a convenient study group of 100 patients on the waiting lists to undergo elective thoracic and abdominal surgery, initially at the Montreal General Hospital (MGH) will be recruited over the next year and a half.
Program:
The program for the current study will consist of two parts, the first being individual counseling with different healthcare professionals, the second component would be a home-based prehabilitation program for patients awaiting their surgery. The healthcare providers available for participants' respective needs include exercise physiologist (a), nutritionists (b), psychosocial (c), and if needed smoking cessation (d) personnel who would contact patients via phone, and a videoconferencing platform (Zoom) if possible, facilitated by the use of the tablet.
Exercise physiologists will follow-up with patients regularly throughout the continuum of care (before and after their surgery) and refer them to the relevant specialists as needed.
The patients will also have access to premade videos prepared by POP to provide additional support in their application of the preoperative recommendations: physical activity (aerobic, resistance, and flexibility), nutrition optimization (healthy eating, improving protein and energy intake, portion size, glycemic control), psychological exercises (breathing exercise, relaxation, imaging, visualization) and smoking cessations. These videos will be available to the patients on their tablets, in addition, the exercises will be demonstrated in the booklets.
Outcome Measures:
All outcomes will be captured via patient chart review, self-report questionnaires, data collected from the Polar watch, and digital surveys. Chart review outcomes include the length of hospital stay, surgical and postoperative complications.
The primary outcome of the current study is to assess the feasibility of distance-delivery of Prehabilitation to these high-priority cancer patients using a digital platform. In order to ascertain if the program was feasible, the evaluation criteria included quantitative measures such as recruitment rate, adherence to program (self-reported measures and crude data from the polar), program completion rate, frequency of technological failures, adverse events, in addition to qualitative measures such as rationale for refusal to participate, low compliance and drop-outs.
Secondary outcomes also include parameters of functional health, nutritional and metabolic status, self-reported outcomes, and surgical outcomes.
Potential confounding variables:
The current study will investigate a diverse patient population. A large degree of variability is to be expected in the observed functional and clinical outcomes. Several factors are known to affect patient prognosis and recovery, among them baseline BMI, smoking status, comorbidities (CCI), type of cancer, neoadjuvant therapies (type and duration) and duration of the prehabilitation program. Therefore, the current study will investigate the impact each factor on the reported outcomes.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Teleprehabilitation cohort
Patients in this single-arm study will receive multimodal teleprehabilitation.
Multimodal Teleprehabilitation
Exercise Prescription: patients will be instructed on how to perform aerobic exercise (5 times/week: minimum 30-minute/day) and resistance training (3 times/week: 2-3 sets of 6-8 exercises repeated 8-12 times) at home. Exercise counseling will be weekly, using the video-conferencing application (Zoom).
Nutrition: nutritional status and dietary intake will initially be assessed by the nutritionist using zoom. All patients will receive daily whey protein supplements. Special precautions will be considered if patients have specific medical conditions.
Psychosocial intervention: Patients will have access to 1.5 hours of mental relaxation and coping mechanisms session within the first week of enrolment, using Zoom.
Smoking Cessation: Patients with smoking habits will meet with a respiratory specialist using Zoom, who will establish recommendations and contact the physician for the recommended smoking cessation protocol.
More counseling sessions will be provided as needed.
Interventions
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Multimodal Teleprehabilitation
Exercise Prescription: patients will be instructed on how to perform aerobic exercise (5 times/week: minimum 30-minute/day) and resistance training (3 times/week: 2-3 sets of 6-8 exercises repeated 8-12 times) at home. Exercise counseling will be weekly, using the video-conferencing application (Zoom).
Nutrition: nutritional status and dietary intake will initially be assessed by the nutritionist using zoom. All patients will receive daily whey protein supplements. Special precautions will be considered if patients have specific medical conditions.
Psychosocial intervention: Patients will have access to 1.5 hours of mental relaxation and coping mechanisms session within the first week of enrolment, using Zoom.
Smoking Cessation: Patients with smoking habits will meet with a respiratory specialist using Zoom, who will establish recommendations and contact the physician for the recommended smoking cessation protocol.
More counseling sessions will be provided as needed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Covered by the RAMQ
* Have medical clearance to exercise (as provided on the physician referral);
* Are able to understand English or French.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Montreal General Hospital
OTHER
Peri Operative Program, Montreal
UNKNOWN
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Franco Carli
Principal Investigator and Professor of Anesthesia
Locations
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Muhc-Rimuhc
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Francesco Carli, MD
Role: primary
References
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Lambert G, Drummond K, Tahasildar B, Carli F. Virtual Prehabilitation in Patients With Cancer Undergoing Surgery During the COVID-19 Pandemic: Protocol for a Prospective Feasibility Study. JMIR Res Protoc. 2022 May 6;11(5):e29936. doi: 10.2196/29936.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MUHC-2021-6730
Identifier Type: -
Identifier Source: org_study_id