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Prehabilitation to Improve Cancer Surgery Outcomes (PICaSO)

Primary Purpose

Gastrointestinal Cancer, Prehabilitation, Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical Prehabilitation
Psychological Prehabilitation
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastrointestinal Cancer focused on measuring Prehabilitation, Gastrointestinal Cancer, Physical Activity, Exercise, Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥ 18 years of age
  • Fluent in English
  • Able to comply with study procedures & follow-up contained within the consent form
  • Pathologically or radiologically confirmed diagnosis of a GI cancer
  • GI cancer must be considered operable
  • Expected LOS ≥ 5 days as calculated by the validated American College of Surgeons Surgical Risk Calculator
  • > 21 days between time of randomization and time of expected surgery
  • Patient written, informed consent obtained according to ICH GCP guidelines and local regulations

Exclusion Criteria:

  • < 18 years old
  • Not fluent in English
  • Planned resection of bony pelvis, limbs, or major lower extremity neurovascular structures
  • Significant comorbidity including any of the following:

    • Canadian Cardiovascular Society class III/IV coronary disease
    • New York Heart Association class III/IV congestive heart failure
    • Neurologic or musculoskeletal disorder prohibiting exercise
    • Major neuropsychiatric disorder

Sites / Locations

  • Sinai Health System - Mount Sinai HospitalRecruiting
  • University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prehabilitation Study Arm

Usual Care Study Arm

Arm Description

Patients will participate in a two-pronged prehabilitation strategy - physical prehabilitation and psychological prehabilitation. Prehabilitation will last from a minimum of 21 days to a maximum of 42 days before a patient's clinically indicated surgery.

No specific exercises or stress reduction techniques are prescribed and the patient will be counseled to continue their current level of activity, and will be given the information on exercise as outlined in the Cancer Care Ontario guidelines. Patients in the Usual Care arm will also be given the same Fitbit activity tracker as patients in the Prehabilitation arm in order to eliminate the activity tracker as an intervention itself and to be able to track the activity (steps) for comparison. Patients in the Usual Care arm will be required to wear their Fitbit activity tracker from the day of randomization to 90 days post-surgery. Patients will record their steps in the diary provided.

Outcomes

Primary Outcome Measures

Global Health Score
The primary outcome is the difference between the baseline and 90-day global health score on the European Organization for the Research and Treatment of Cancer (EORTC) QLC-C30

Secondary Outcome Measures

Presence and severity of postoperative complications
The presence and severity of postoperative complications at 30 and 90 days will be recorded from the patient's medical records
Postoperative hospital length of stay
The patient's postoperative length of stay will be recorded from the medical records
Changes in functional capacity from baseline
Patients will perform a 6-Minute Walk Test.
Changes in self-reported physical activity from baseline
Changes in self-reported physical activity will be measured using the Godin Leisure-time Exercise Questionnaire
Changes in health-related quality of life from baseline
HRQOL will be measured using the EQ-5D Health Questionnaire
Presence and severity of symptoms
The presence and severity of nine common symptoms in cancer patients will be examined using the Edmonton Symptom Assessment Scale (ESAS). This self-report measure examines: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath.
Changes in anxiety and depression from baseline
Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale (HADS). HADS assesses anxiety and depression through self-reporting based on the frequency of symptoms over the past week. There are 2 subscales, one for anxiety and for depression, each with 7 items. Items are scored on a 4 point Likert scale (0-3), with the subscale scores being sums of each item (0-21). A higher score is indicative of higher or worse anxiety and depression.
Changes in fatigue from baseline
Changes in cancer-specific fatigue will be assessed using the 13-item Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
Interference with occupational performance and productivity
The degree to which the patient's health problems interfere with occupational performance and productivity will be examined using the Work Limitations Questionnaire
Changes in multidimensional social support
Changes in the perceived availability of multidimensional social support will be evaluated using the Medical Outcomes Study Social Support Scale (MOS-SSS SF-20). The MOS-SSS SF-20 is a 20 item questionnaire that measures physical functioning, social functioning, mental health, current health perceptions, and pain. After reverse scoring of the appropriate items according to the MOS-SSS core scoring manual, a higher value indicates better functioning, health, and more pain in the respective measures. All measure scores are transformed linearly to scales from 0-100, with 100 being the highest score possible.
Changes in attachment (closeness in relationships with others)
The Experiences in Close Relationships Scale (ECR M16) will be used to examine adult attachment or closeness in both romantic and non-romantic relationships. There are two domains that are measured - attachment anxiety and avoidance. Each domain includes 8 items. Items are scored on a 7 point Likert Scale (1-7). After appropriate reverse scoring, a high score indicates higher attachment anxiety or avoidance.
Health care utilization
Health care utilization will be assessed at the postoperative 3 and 6 month time points using the Health Service Utilization Inventory

Full Information

First Posted
March 25, 2018
Last Updated
February 25, 2020
Sponsor
Mount Sinai Hospital, Canada
Collaborators
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03502317
Brief Title
Prehabilitation to Improve Cancer Surgery Outcomes
Acronym
PICaSO
Official Title
Prehabilitation to Improve Cancer Surgery Outcomes (PICaSO): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized control trial aiming to investigate the use of a prehabilitation regimen for patients undergoing major GI cancer surgery and its effects on measurements of HRQOL, LOS, and post-operative complications. Participants will be randomized to either the Prehabilitation arm or the Usual Care arm (control group). The Prehabilitation arm will be prescribed both physical and psychological prehabilitation prior to undergoing surgery for their GI cancer. The Usual Care arm will be counseled to continue their current level of activity and given the information on exercise as outlined in the Cancer Care Ontario guidelines. Participants in the Usual Care arm will also be given the same activity tracker as patients in the Prehabilitation arm in order to eliminate the activity tracker as an intervention itself. Clinical, patient-reported outcomes and health system outcomes will be evaluated. Outcomes will be measured at consent (baseline), immediately preoperatively, and postoperatively at 1, 3 and 6 months. The investigators will collect measures of recruitment, attrition and self-reported compliance via a log completed by the coordinator during weekly patient phone calls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer, Prehabilitation, Surgery, Physical Activity
Keywords
Prehabilitation, Gastrointestinal Cancer, Physical Activity, Exercise, Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prehabilitation Study Arm
Arm Type
Experimental
Arm Description
Patients will participate in a two-pronged prehabilitation strategy - physical prehabilitation and psychological prehabilitation. Prehabilitation will last from a minimum of 21 days to a maximum of 42 days before a patient's clinically indicated surgery.
Arm Title
Usual Care Study Arm
Arm Type
No Intervention
Arm Description
No specific exercises or stress reduction techniques are prescribed and the patient will be counseled to continue their current level of activity, and will be given the information on exercise as outlined in the Cancer Care Ontario guidelines. Patients in the Usual Care arm will also be given the same Fitbit activity tracker as patients in the Prehabilitation arm in order to eliminate the activity tracker as an intervention itself and to be able to track the activity (steps) for comparison. Patients in the Usual Care arm will be required to wear their Fitbit activity tracker from the day of randomization to 90 days post-surgery. Patients will record their steps in the diary provided.
Intervention Type
Behavioral
Intervention Name(s)
Physical Prehabilitation
Intervention Description
Physical prehabilitation will comprise a personalized, home-based exercise program designed to meet the Cancer Care Ontario Exercise Guidelines for Cancer Survivors. A Registered Kinesiologist (RKin) will complete a baseline physical assessment and prescribe an individualized multi-modal exercise program consisting of 4-5 days of 30+ minutes of aerobic exercise (brisk walking or equivalent to target heart rate of 40-60% of max) and 2-3 days of moderate intensity resistance training of major muscle groups (8-10 repetitions). Participants will be provided with a Fitbit with a heart rate monitor, resistance bands, and a stability ball. Patients will be required to wear their Fitbit and record the number of steps at the end of each day from randomization to 90 days post-surgery.
Intervention Type
Behavioral
Intervention Name(s)
Psychological Prehabilitation
Intervention Description
Psychological prehabilitation will consist of one in-person coaching session of a 'mindfulness' informed intervention conducted by a specially trained RKin. The 40 minute coaching session will include a guided mindfulness session and debriefing. Participants will be asked to practice for 20 minutes twice a day. The patients will be given access to an audio file that will walk them through the 20 minute sessions.
Primary Outcome Measure Information:
Title
Global Health Score
Description
The primary outcome is the difference between the baseline and 90-day global health score on the European Organization for the Research and Treatment of Cancer (EORTC) QLC-C30
Time Frame
Baseline to postoperative day 90
Secondary Outcome Measure Information:
Title
Presence and severity of postoperative complications
Description
The presence and severity of postoperative complications at 30 and 90 days will be recorded from the patient's medical records
Time Frame
Postoperatively through to day 30 and day 90
Title
Postoperative hospital length of stay
Description
The patient's postoperative length of stay will be recorded from the medical records
Time Frame
Length of stay will be calculated from the date of surgery until to the date of discharge from the hospital, reported in days, assessed up to 6 months postoperatively.
Title
Changes in functional capacity from baseline
Description
Patients will perform a 6-Minute Walk Test.
Time Frame
Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Title
Changes in self-reported physical activity from baseline
Description
Changes in self-reported physical activity will be measured using the Godin Leisure-time Exercise Questionnaire
Time Frame
Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Title
Changes in health-related quality of life from baseline
Description
HRQOL will be measured using the EQ-5D Health Questionnaire
Time Frame
Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Title
Presence and severity of symptoms
Description
The presence and severity of nine common symptoms in cancer patients will be examined using the Edmonton Symptom Assessment Scale (ESAS). This self-report measure examines: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath.
Time Frame
Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Title
Changes in anxiety and depression from baseline
Description
Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale (HADS). HADS assesses anxiety and depression through self-reporting based on the frequency of symptoms over the past week. There are 2 subscales, one for anxiety and for depression, each with 7 items. Items are scored on a 4 point Likert scale (0-3), with the subscale scores being sums of each item (0-21). A higher score is indicative of higher or worse anxiety and depression.
Time Frame
Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Title
Changes in fatigue from baseline
Description
Changes in cancer-specific fatigue will be assessed using the 13-item Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
Time Frame
Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Title
Interference with occupational performance and productivity
Description
The degree to which the patient's health problems interfere with occupational performance and productivity will be examined using the Work Limitations Questionnaire
Time Frame
Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Title
Changes in multidimensional social support
Description
Changes in the perceived availability of multidimensional social support will be evaluated using the Medical Outcomes Study Social Support Scale (MOS-SSS SF-20). The MOS-SSS SF-20 is a 20 item questionnaire that measures physical functioning, social functioning, mental health, current health perceptions, and pain. After reverse scoring of the appropriate items according to the MOS-SSS core scoring manual, a higher value indicates better functioning, health, and more pain in the respective measures. All measure scores are transformed linearly to scales from 0-100, with 100 being the highest score possible.
Time Frame
Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Title
Changes in attachment (closeness in relationships with others)
Description
The Experiences in Close Relationships Scale (ECR M16) will be used to examine adult attachment or closeness in both romantic and non-romantic relationships. There are two domains that are measured - attachment anxiety and avoidance. Each domain includes 8 items. Items are scored on a 7 point Likert Scale (1-7). After appropriate reverse scoring, a high score indicates higher attachment anxiety or avoidance.
Time Frame
Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Title
Health care utilization
Description
Health care utilization will be assessed at the postoperative 3 and 6 month time points using the Health Service Utilization Inventory
Time Frame
post-operatively at 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years of age Fluent in English Able to comply with study procedures & follow-up contained within the consent form Pathologically or radiologically confirmed diagnosis of a GI cancer GI cancer must be considered operable Expected LOS ≥ 5 days as calculated by the validated American College of Surgeons Surgical Risk Calculator > 21 days between time of randomization and time of expected surgery Patient written, informed consent obtained according to ICH GCP guidelines and local regulations Exclusion Criteria: < 18 years old Not fluent in English Planned resection of bony pelvis, limbs, or major lower extremity neurovascular structures Significant comorbidity including any of the following: Canadian Cardiovascular Society class III/IV coronary disease New York Heart Association class III/IV congestive heart failure Neurologic or musculoskeletal disorder prohibiting exercise Major neuropsychiatric disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Taylor
Phone
416-586-4800
Ext
4990
Email
emily.taylor@sinaihealthsystem.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Aitken
Email
rachel.aitken@mail.utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Govindarajan, MD MSc
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sinai Health System - Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Taylor
Phone
4165864800
Ext
4990
Email
emily.taylor@sinaihealthsystem.ca
First Name & Middle Initial & Last Name & Degree
Rachel Aitken
Phone
6479735918
Email
rachel.aitken@mail.utoronto.ca
First Name & Middle Initial & Last Name & Degree
Anand Govindarajan, MD, MSc
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Taylor
Phone
4165864800
Ext
4990
Email
emily.taylor@sinaihealthsystem.ca
First Name & Middle Initial & Last Name & Degree
Rachel Aitken
Phone
6479735918
Email
rachel.aitken@mail.utoronto.ca
First Name & Middle Initial & Last Name & Degree
Anand Govindarajan, MD, MSc

12. IPD Sharing Statement

Learn more about this trial

Prehabilitation to Improve Cancer Surgery Outcomes

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