Clinical trial NCT04799561: Teleprehabilitation for Surgical Cancer Patients
Official title: Virtual Prehabilitation of Surgical Cancer Patients in Times of the Covid-19 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Cancer
Thoracic Cancer
Keywords: Telehealth
Telemedecine
Prehabilitation
Supportive Care
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Montreal General Hospital
name: Peri Operative Program, Montreal
First posted: 2021-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* N.A.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Through study completion, for an expected duration of of 1.5 year.
measure: Adherence
timeFrame: Through study completion, for an expected duration of of 1.5 year.
measure: Program Completion Rate
timeFrame: Through study completion, for an expected duration of of 1.5 year.
measure: frequency of Technological Failures
timeFrame: Through study completion, for an expected duration of of 1.5 year.
measure: Intervention-Related Adverse Events
timeFrame: Through study completion, for an expected duration of of 1.5 year.
measure: Rational for Refusal to Participate
timeFrame: Through study completion, for an expected duration of of 1.5 year.
measure: Rational for Low Compliance
timeFrame: Through study completion, for an expected duration of of 1.5 year.
measure: Rational for Drop-Outs
timeFrame: Through study completion, for an expected duration of of 1.5 year.
Secondary outcomes:
measure: 30 Second Sit-to-Stand
timeFrame: 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
measure: Time-Up and Go (TUG)
timeFrame: 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
measure: 2- or 6-Minute Walk Test
timeFrame: 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
measure: Abridged-Scored Patient-Generated Subjective Global Assessment (PG-SGA)
timeFrame: 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
measure: Body Mass Index (BMI)
timeFrame: 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
measure: CRP
timeFrame: During baseline assessment (beginning of prehabilitation period; T0)
measure: Serum Albumin
timeFrame: During baseline assessment (beginning of prehabilitation period; T0)
measure: Duke Activity Status Index (DASI)
timeFrame: 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
measure: Quality of Life (EQ5D)
timeFrame: 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
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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
measure: Distress Thermometer
timeFrame: 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
measure: The WHO Disability Assessment Schedule v2.0 (WHODAS)
timeFrame: 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
measure: The Energy Expenditure (CHAMPS)
timeFrame: 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
measure: The Clavien-Dindo Classifications(CDC)
timeFrame: During the post-operative period, data collected on average up to 2 months after the surgery date.
measure: The Comprehensive Complication Index (CCI)
timeFrame: During the post-operative period, data collected on average up to 2 months after the surgery date.
measure: The 30-day Mortality
timeFrame: During the post-operative period, for a month after the surgery date.
measure: Length of Intensive Care Stay
timeFrame: During the post-operative period, data collected on average up to 2 months after the surgery date.
measure: Days with a chest tube
timeFrame: During the post-operative period, data collected on average up to 2 months after the surgery date.
measure: Length of Hospital Stay
timeFrame: During the post-operative period, data collected on average up to 2 months after the surgery date.
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Muhc-Rimuhc
state: Quebec
Study officials:
References:
citation: 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.