Prehabilitation to Improve Cancer Surgery Outcomes

Surgery Clinical Trial

— PICaSO  

Official title:

Prehabilitation to Improve Cancer Surgery Outcomes (PICaSO): A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03502317
• Other study ID #: 17-0185
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: February 2020
• Source: Mount Sinai Hospital, Canada
• Contact: Emily Taylor
• Phone: 416-586-4800
• Email: emily.taylor[@]sinaihealthsystem.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: March 31, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Physical Activity
• Prehabilitation
• Surgery

Intervention

Behavioral:
• Physical Prehabilitation
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 Prehabilitation
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.

Locations

Country	Name	City	State
Canada	Sinai Health System - Mount Sinai Hospital	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to postoperative day 90
Secondary	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	Postoperatively through to day 30 and day 90
Secondary	Postoperative hospital length of stay	The patient's postoperative length of stay will be recorded from the medical records	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.
Secondary	Changes in functional capacity from baseline	Patients will perform a 6-Minute Walk Test.	Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Secondary	Changes in self-reported physical activity from baseline	Changes in self-reported physical activity will be measured using the Godin Leisure-time Exercise Questionnaire	Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Secondary	Changes in health-related quality of life from baseline	HRQOL will be measured using the EQ-5D Health Questionnaire	Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Secondary	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.	Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Secondary	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.	Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Secondary	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).	Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Secondary	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	Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Secondary	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.	Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Secondary	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.	Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Secondary	Health care utilization	Health care utilization will be assessed at the postoperative 3 and 6 month time points using the Health Service Utilization Inventory	post-operatively at 3 and 6 months