Teleprehabilitation for Surgical Cancer Patients

NCT04799561 | Unknown

• 1 other identifier: MUHC-2021-6730
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Cancer; Thoracic Cancer

Keywords

Telehealth; Telemedecine; Prehabilitation; Supportive Care

Outcome Measures

Primary Outcomes (8)

• Recruitment Rate

  Recruitment rate is defined as the number of participant recruited, compared to the number of eligible participant contacted.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  Through study completion, for an expected duration of of 1.5 year.

Secondary Outcomes (19)

• 30 Second Sit-to-Stand

  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)

  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

  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)

  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)

  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

Study Arms (1)

Teleprehabilitation cohort

EXPERIMENTAL

Patients in this single-arm study will receive multimodal teleprehabilitation.

Behavioral: Multimodal Teleprehabilitation

Interventions

Multimodal Teleprehabilitation BEHAVIORAL

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.

Also known as: Virtual Prehabilitation

Teleprehabilitation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• N.A.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Montreal General Hospital: collaborator
• Peri Operative Program, Montreal: collaborator

Study Sites (1)

Muhc-Rimuhc

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 35522464 DERIVED

Central Study Contacts

Francesco Carli, MD, MPhil

CONTACT

514-934-1934; franco.carli@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Professor of Anesthesia

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 16, 2021
• Study Start: March 12, 2021
• Primary Completion: September 15, 2022
• Study Completion: December 15, 2022
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)