Gastrointestinal CancerPICaSONCT03502317
Prehabilitation to Improve Cancer Surgery Outcomes
A study testing Physical Prehabilitation and Psychological Prehabilitation in people with Gastrointestinal Cancer and Prehabilitation, run by Mount Sinai Hospital, Canada at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Prehabilitation, Surgery
- What is being tested?
- Physical Prehabilitation and Psychological Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesCanada
- Study dates
- 14 Aug 2018to 31 Mar 2021
- 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
- ≥ 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
Who cannot join
- < 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
Trial locations and contacts
2 sites in 1 country.
Rachel Aitken contact
Canada2 sites, 2 recruiting
- Recruiting
Sinai Health System - Mount Sinai Hospital
Toronto, Ontario, M5G1X5
Emily Taylor, 4165864800 ext. 4990, emily.taylor@sinaihealthsystem.ca
Rachel Aitken, 6479735918, rachel.aitken@mail.utoronto.ca
- Recruiting
University Health Network
Toronto, Ontario
Emily Taylor, 4165864800 ext. 4990, emily.taylor@sinaihealthsystem.ca
Rachel Aitken, 6479735918, rachel.aitken@mail.utoronto.ca
About this study
Official title: Prehabilitation to Improve Cancer Surgery Outcomes (PICaSO): A Randomized Controlled Trial
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.
- Conditions
- Gastrointestinal Cancer, Prehabilitation, Surgery, Physical Activity
- Being tested
- Physical Prehabilitation, Psychological Prehabilitation
- Keywords
- Prehabilitation, Gastrointestinal Cancer, Physical Activity, Exercise, Surgery
- Medical subject headings
- Gastrointestinal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical PrehabilitationBehavioural
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.
Psychological PrehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation Study Arm | Experimental | 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. Receives: Behavioral: Physical Prehabilitation; Behavioral: Psychological Prehabilitation |
| Usual Care Study Arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to postoperative day 90
Secondary outcomes (12)
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
Measured: Postoperatively through to day 30 and day 90
Postoperative hospital length of stay
The patient's postoperative length of stay will be recorded from the medical records
Measured: 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.
Changes in functional capacity from baseline
Patients will perform a 6-Minute Walk Test.
Measured: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Changes in self-reported physical activity from baseline
Changes in self-reported physical activity will be measured using the Godin Leisure-time Exercise Questionnaire
Measured: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Changes in health-related quality of life from baseline
HRQOL will be measured using the EQ-5D Health Questionnaire
Measured: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
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.
Measured: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
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.
Measured: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
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).
Measured: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
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
Measured: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
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.
Measured: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
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.
Measured: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Health care utilization
Health care utilization will be assessed at the postoperative 3 and 6 month time points using the Health Service Utilization Inventory
Measured: post-operatively at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start14 Aug 2018
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Anand Govindarajan, MD MSc, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502317
- Sponsor's protocol ID
- 17-0185
- Acronym
- PICaSO
- Status last verified
- Feb 2020
- First submitted
- 25 Mar 2018
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation to Improve Cancer Surgery Outcomes (PICaSO): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03502317
- Acronym / sponsor ID
- PICaSO / 17-0185
- Conditions
- Gastrointestinal Cancer, Prehabilitation, Surgery, Physical Activity
- Keywords
- Prehabilitation, Gastrointestinal Cancer, Physical Activity, Exercise, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 18 Apr 2018 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation Study Arm | Experimental | Behavioral: Physical Prehabilitation, Behavioral: Psychological PrehabilitationPatients 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. |
| Usual Care Study Arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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
Key exclusion criteria (8 listed)
- < 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:
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 |
|---|---|---|
| Physical PrehabilitationPhysical 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. | Behavioural | Prehabilitation Study Arm |
| Psychological PrehabilitationPsychological 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. | Behavioural | Prehabilitation Study Arm |
Primary outcome
Global Health Score
Time frame: Baseline to postoperative day 90
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
12 secondary outcomes
Presence and severity of postoperative complications
Time frame: Postoperatively through to day 30 and day 90
Postoperative hospital length of stay
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.
Changes in functional capacity from baseline
Time frame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Changes in self-reported physical activity from baseline
Time frame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Changes in health-related quality of life from baseline
Time frame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Presence and severity of symptoms
Time frame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Changes in anxiety and depression from baseline
Time frame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Changes in fatigue from baseline
Time frame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Interference with occupational performance and productivity
Time frame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Changes in multidimensional social support
Time frame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Changes in attachment (closeness in relationships with others)
Time frame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Health care utilization
Time frame: post-operatively at 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
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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.
Rachel Aitken contact
Anand Govindarajan, MD MSc principal investigator
MOUNT SINAI HOSPITAL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Prehabilitation and Psychological Prehabilitation in people with Gastrointestinal Cancer and Prehabilitation, run by Mount Sinai Hospital, Canada at 2 sites 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 8 inclusion and 8 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 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Emily Taylor (416-586-4800 ext. 4990, emily.taylor@sinaihealthsystem.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Health Score (time frame: Baseline to postoperative day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2020.