Recruiting

Prehabilitation Program

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT04799561

Conditions

Abdominal Cancer

Thoracic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multimodal Teleprehabilitation

Study Details

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

Study ID

NCT04799561

Start date

Mar 12, 2021

Status verified date

Sep, 2021

Completion date

Dec 15, 2022

Anticipated

Primary completion date

Sep 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Teleprehabilitation cohort

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

Interventions

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.

Primary outcome measure

  • Recruitment Rate [ Time Frame: Through study completion, for an expected duration of of 1.5 year. ]
  • Adherence [ Time Frame: Through study completion, for an expected duration of of 1.5 year. ]
  • Program Completion Rate [ Time Frame: Through study completion, for an expected duration of of 1.5 year. ]
  • frequency of Technological Failures [ Time Frame: Through study completion, for an expected duration of of 1.5 year. ]
  • Intervention-Related Adverse Events [ Time Frame: Through study completion, for an expected duration of of 1.5 year. ]
  • Rational for Refusal to Participate [ Time Frame: Through study completion, for an expected duration of of 1.5 year. ]
  • Rational for Low Compliance [ Time Frame: Through study completion, for an expected duration of of 1.5 year. ]
  • Rational for Drop-Outs [ Time Frame: Through study completion, for an expected duration of of 1.5 year. ]

Central Contacts and Locations

Central contacts

Francesco Carli, MD, MPhil

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

Locations

Muhc-Rimuhc

Recruiting

Montréal, Quebec, Canada, H3G 1A4

Contacts

Francesco Carli, MD

5149341934franco.carli@mcgill.ca

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Sep 30, 2021

Last verified

Sep, 2021

Keywords

  • Telehealth
  • Telemedecine
  • Prehabilitation
  • Supportive Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2021-09-30.