Abdominal CancerNCT04799561
Teleprehabilitation for Surgical Cancer Patients
A study testing Multimodal Teleprehabilitation in people with Abdominal Cancer and Thoracic Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Cancer, Thoracic Cancer
- What is being tested?
- Multimodal Teleprehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 12 Mar 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults scheduled for elective cancer surgery that is delayed due to COVID-19 referred by a surgeon;
- Covered by the RAMQ
- Have medical clearance to exercise (as provided on the physician referral);
- Are able to understand English or French.
Who cannot join
- N.A.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Muhc-Rimuhc
Montreal, Quebec, H3G 1A4
Francesco Carli, MD, 5149341934 ext. 44188, franco.carli@mcgill.ca
About this study
Official title: Virtual Prehabilitation of Surgical Cancer Patients in Times of the Covid-19 Pandemic
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.
Read the 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.
- Conditions
- Abdominal Cancer, Thoracic Cancer
- Being tested
- Multimodal Teleprehabilitation
- Keywords
- Telehealth, Telemedecine, Prehabilitation, Supportive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal TeleprehabilitationBehavioural
Also called Virtual Prehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| Teleprehabilitation cohort | Experimental | Patients in this single-arm study will receive multimodal teleprehabilitation. Receives: Behavioral: Multimodal Teleprehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Recruitment rate is defined as the number of participant recruited, compared to the number of eligible participant contacted.
Measured: Through study completion, for an expected duration of of 1.5 year.
Adherence
based on self-reported measures and data from the polar watch, compared to prescribed intervention
Measured: Through study completion, for an expected duration of of 1.5 year.
Program Completion Rate
The completion rate is defined as the number of participant completing all evaluations, compared to the number of participants recruited.
Measured: Through study completion, for an expected duration of of 1.5 year.
frequency of Technological Failures
Frequency of technological failures is defined as the number of any technological challenge that would prevent participants from doing their interventions or contacting the research team member.
Measured: Through study completion, for an expected duration of of 1.5 year.
Intervention-Related Adverse Events
Intervention-related adverse events is defined as any event that would cause harm to patients' physical or mental health.
Measured: Through study completion, for an expected duration of of 1.5 year.
Rational for Refusal to Participate
When possible, patients' rational for refusing to participate in the project was collected.
Measured: Through study completion, for an expected duration of of 1.5 year.
Rational for Low Compliance
When possible, participant's rational for low compliance to the project was collected.
Measured: Through study completion, for an expected duration of of 1.5 year.
Rational for Drop-Outs
When possible, participant's rational for abandoning the project was collected.
Measured: Through study completion, for an expected duration of of 1.5 year.
Secondary outcomes (19)
30 Second Sit-to-Stand
Assessed the strength of the lower body, by sitting on a chair and standing up as many times as possible during 30 seconds.
Measured: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
Time-Up and Go (TUG)
Assessed mobility, balance and locomotor performance associated to the tasks of walking and turning. The patients starts seated, and needs to stand up, walk turn around a cone and sit back down as fast as possible, the results is the numbers of seconds to perform the 3-meter distance to a cone and back.
Measured: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
2- or 6-Minute Walk Test
The 2- or 6-minute walk test is a functional capacity measure, surrogate to the assessment of cardiopulmonary capacities. The patient walks in a 20-meter corridor, back and forth, for 2 or 6 minutes and the result of the test is the distances traveled in meters.
Measured: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
Abridged-Scored Patient-Generated Subjective Global Assessment (PG-SGA)
Assessed the state of nutrition, classification A, B or C ( B and C being states of nutritional risk).
Measured: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
Body Mass Index (BMI)
Assessed the body composition, ranging 18 to 30 (>30 is obesity, and <18 is malnourished).
Measured: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
CRP
Assessed the degree of inflammation (>10mg/L indicates high inflammation )
Measured: During baseline assessment (beginning of prehabilitation period; T0)
Serum Albumin
Assessed the degree of inflammation (<35g/L indicates high inflammation)
Measured: During baseline assessment (beginning of prehabilitation period; T0)
Duke Activity Status Index (DASI)
Assessed the level of physical activity and is measured in 12 questions, going up to a score of 58 (58 being the best score).
Measured: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
Quality of Life (EQ5D)
Assessed the quality of life of the previous week, on a scale of 0 to 100 ( 100 being the best health).
Measured: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
The Hospital Anxiety and Depression Scale (HADS)
Assessed the degree of anxiety and depression, separately, ranging from 0 to 18 respectively (18 being the worst score).
Measured: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
Distress Thermometer
Assessment of the level of anxiety and distress, on a scale from 0 to 10 (10 being the worst score).
Measured: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
The WHO Disability Assessment Schedule v2.0 (WHODAS)
the WHO Disability Assessment Schedule is a scale of disability free survival, measured at different times,
Measured: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
The Energy Expenditure (CHAMPS)
the energy expenditure related to physical activities of daily living, measured in kilocalories/kg/week.
Measured: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
The Clavien-Dindo Classifications(CDC)
The Clavien-Dindo Classifications(CDC) indicates the resource utilization of complication post-operatively, ranging from 0 to 4 (4 being patient admitted to the intensive care).
Measured: During the post-operative period, data collected on average up to 2 months after the surgery date.
The Comprehensive Complication Index (CCI)
The comprehensive complication index (CCI) is a score of the r severity of post-operative complications, ranging from 0 to 100 (100 being mortality).
Measured: During the post-operative period, data collected on average up to 2 months after the surgery date.
The 30-day Mortality
The 30-day mortality will assess the number of deaths within the first 30 days post-surgery.
Measured: During the post-operative period, for a month after the surgery date.
Length of Intensive Care Stay
Length of intensive care stay will be assessed as the number of hours from arrival to the unit.
Measured: During the post-operative period, data collected on average up to 2 months after the surgery date.
Days with a chest tube
Days with a chest tube will be assessed as the number of days and hours for the last day, if applicable.
Measured: During the post-operative period, data collected on average up to 2 months after the surgery date.
Length of Hospital Stay
Length of Hospital Stay will be assessed as a number of post-operative hours until discharge
Measured: During the post-operative period, data collected on average up to 2 months after the surgery date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start12 Mar 2021
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This QI study will include one group of 100 patients who will receive distance-delivered support for all components of the home-based prehabilitation regimen in addition to 2 months of follow-up post-surgery. The program will include: exercise, nutrition, mental well-being and, if needed, smoking cessation. The technologies (a tablet and an active lifestyle watch) will be used to provide counselling, educate patients on lifestyle modifications and assess adherence remotely. Telephone calls will also be made on a weekly basis, if participants were unable to attend their video-conferencing counselling sessions.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Montreal General Hospital, Peri Operative Program, Montreal
- Responsible party
- Principal investigator, Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799561
- Sponsor's protocol ID
- MUHC-2021-6730
- Status last verified
- Sep 2021
- First submitted
- 1 Mar 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35522464
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Prehabilitation of Surgical Cancer Patients in Times of the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04799561
- Acronym / sponsor ID
- MUHC-2021-6730
- Conditions
- Abdominal Cancer, Thoracic Cancer
- Keywords
- Telehealth, Telemedecine, Prehabilitation, Supportive Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Montreal General Hospital, Peri Operative Program, Montreal
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This QI study will include one group of 100 patients who will receive distance-delivered support for all components of the home-based prehabilitation regimen in addition to 2 months of follow-up post-surgery. The program will include: exercise, nutrition, mental well-being and, if needed, smoking cessation. The technologies (a tablet and an active lifestyle watch) will be used to provide counselling, educate patients on lifestyle modifications and assess adherence remotely. Telephone calls will also be made on a weekly basis, if participants were unable to attend their video-conferencing counselling sessions.
| Arm | Type | Receives |
|---|---|---|
| Teleprehabilitation cohort | Experimental | Behavioral: Multimodal TeleprehabilitationPatients in this single-arm study will receive multimodal teleprehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults scheduled for elective cancer surgery that is delayed due to COVID-19 referred by a surgeon;
- Covered by the RAMQ
- Have medical clearance to exercise (as provided on the physician referral);
- Are able to understand English or French.
Key exclusion criteria (1 listed)
- N.A.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal TeleprehabilitationAlso: Virtual PrehabilitationExercise 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. | Behavioural | Teleprehabilitation cohort |
Primary outcome
Recruitment Rate
Time frame: Through study completion, for an expected duration of of 1.5 year.
Recruitment rate is defined as the number of participant recruited, compared to the number of eligible participant contacted.
Adherence
Time frame: Through study completion, for an expected duration of of 1.5 year.
based on self-reported measures and data from the polar watch, compared to prescribed intervention
Program Completion Rate
Time frame: Through study completion, for an expected duration of of 1.5 year.
The completion rate is defined as the number of participant completing all evaluations, compared to the number of participants recruited.
frequency of Technological Failures
Time frame: Through study completion, for an expected duration of of 1.5 year.
Frequency of technological failures is defined as the number of any technological challenge that would prevent participants from doing their interventions or contacting the research team member.
Intervention-Related Adverse Events
Time frame: Through study completion, for an expected duration of of 1.5 year.
Intervention-related adverse events is defined as any event that would cause harm to patients' physical or mental health.
Rational for Refusal to Participate
Time frame: Through study completion, for an expected duration of of 1.5 year.
When possible, patients' rational for refusing to participate in the project was collected.
Rational for Low Compliance
Time frame: Through study completion, for an expected duration of of 1.5 year.
When possible, participant's rational for low compliance to the project was collected.
Rational for Drop-Outs
Time frame: Through study completion, for an expected duration of of 1.5 year.
When possible, participant's rational for abandoning the project was collected.
19 secondary outcomes
30 Second Sit-to-Stand
Time frame: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
Time-Up and Go (TUG)
Time frame: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
2- or 6-Minute Walk Test
Time frame: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
Abridged-Scored Patient-Generated Subjective Global Assessment (PG-SGA)
Time frame: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
Body Mass Index (BMI)
Time frame: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
CRP
Time frame: During baseline assessment (beginning of prehabilitation period; T0)
Serum Albumin
Time frame: During baseline assessment (beginning of prehabilitation period; T0)
Duke Activity Status Index (DASI)
Time frame: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
Quality of Life (EQ5D)
Time frame: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
The Hospital Anxiety and Depression Scale (HADS)
Time frame: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
Distress Thermometer
Time frame: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
The WHO Disability Assessment Schedule v2.0 (WHODAS)
Time frame: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
The Energy Expenditure (CHAMPS)
Time frame: During baseline assessment (beginning of prehabilitation period; T0), at the preoperative assessment (within the 24 hours prior to surgery; T1) and further at the 4- (T2) and 8-weeks (T3) follow-ups after surgery
The Clavien-Dindo Classifications(CDC)
Time frame: During the post-operative period, data collected on average up to 2 months after the surgery date.
The Comprehensive Complication Index (CCI)
Time frame: During the post-operative period, data collected on average up to 2 months after the surgery date.
The 30-day Mortality
Time frame: During the post-operative period, for a month after the surgery date.
Length of Intensive Care Stay
Time frame: During the post-operative period, data collected on average up to 2 months after the surgery date.
Days with a chest tube
Time frame: During the post-operative period, data collected on average up to 2 months after the surgery date.
Length of Hospital Stay
Time frame: During the post-operative period, data collected on average up to 2 months after the surgery date.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Derived from this study: PubMed 35522464Lambert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Teleprehabilitation in people with Abdominal Cancer and Thoracic Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Carli, MD, MPhil (514-934-1934 ext. 43728, franco.carli@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Through study completion, for an expected duration of of 1.5 year.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04799561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.