Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04799561
Status:
UNKNOWN
Last Update Posted:
2021-09-30
First Post:
2021-03-01
Brief Title:
Teleprehabilitation for Surgical Cancer Patients
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Virtual Prehabilitation of Surgical Cancer Patients in Times of the Covid-19 Pandemic
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is a general concern that the backlog of cancer patients waiting for surgery during this period is going to increase and the general impact on patients isolated in their homes is going to cause potential physiological and psychological impairments Therefore we propose a distanced-delivered personalized home-based prehabilitation program to all cancer patients scheduled for surgery at the MUHC The program will be delivered by qualified professionals supported by technology provided by POP to all cancer patients waiting for surgery addressing the patients risk factors in patients pandemic reality perspective Participant contacts will primarily occur virtually using technologies such as video conferencing and digital applications This will enable us to continue to support people with cancer and deliver safe remote counseling by specialist healthcare providers in their own homes whilst adhering to the Governmental guidelines on social distancing self-isolation and shielding
Detailed Description:
The current project aims to improve the quality of care delivered to oncologic surgical candidates during the COVID-19 pandemic The specific objectives of the study are 1 to assess the feasibility of a distance-delivered prehabilitation program to oncologic surgical candidates in light of the current global pandemic 2 to measure the effect of technology-supported prehabilitation on preoperative and postoperative functional capacity and clinical outcomes and 3 To qualitatively investigate the impact of distance-delivery of prehabilitation on health-related quality of life anxiety and depression which may be exacerbated by the current global phenomenon
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None