Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care (TPC-RCT)

Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care: A Randomized Control Trial

Trimodal prehabilitation is a preoperative three-tiered (trimodal) approach to optimizing physical and mental health. It has been found to successfully improve functional recovery in patients undergoing colorectal surgery following an evidence-based enhanced-recovery pathway (ERP). It is unknown whether the same program is effective in patients undergoing a similar surgery for bladder cancer (radical cystectomy).

Objective: To evaluate the appropriateness of a standardized prehabilitation program for implementation into an enhanced recovery pathway for cystectomy patients and determine whether prehabilitation facilitates earlier recovery of functional capacity.

Hypothesis: Prehabilitation will ultimately improve recovery of functional capacity, clinical and patient-centered outcomes in patients undergoing radical cystectomy for bladder cancer.

Design: Participants will follow an 8-week trimodal prehabilitation program consisting of exercise therapy combined with nutritional counseling, protein supplementation, and psychological care; they will be compared to a cohort of participants following ERP care alone.

Conclusion: The proposal will provide insight into the feasibility and effectiveness of trimodal prehabilitation for radical cystectomy patients and may ultimately lead to improved clinical outcomes and reduced morbidity.

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer; Nutrition Aspect of Cancer
• Intervention / Treatment: Combination product: Trimodal Prehab & ERP; Other: No Prehab; ERP Alone

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason Martyn, MScPT; Phone Number: 403-943-3575; Email: jason.martyn@ahs.ca
• Study Contact Backup: Name: Chelsia Gillis, PhD; Email: chelsia.gillis@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female ≥ 18 years of age at time of consent for surgery.
2. Documentation of bladder cancer diagnosis as evidenced by diagnostic imaging and biopsy.
3. May or may not receive adjuvant therapy.
4. Written informed consent obtained from subject

Exclusion Criteria:

1. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or adherence to the program. This includes:

   1. American Society of Anesthesiologists (ASA) health class status 4-5;
   2. Co-morbid medical, physical, and/or mental conditions including dementia, disabling orthopedic and neuromuscular disease, psychosis;
   3. Severe cardiac abnormalities, end-stage organ disease, sepsis, or morbid obesity (BMI greater than 35);
2. Undergoing radical cystectomy for a reason other than bladder cancer.
3. Poor comprehension of English or French
4. Screened by Total Cardiology staff and determined to be inappropriate for prehabilitation at their facility.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Trimodal Prehab & ERP; Trimodal prehab includes: Guided exercise program at Repsol Place in Calgary, Alberta 2x/week, hosted by the Total Cardiology group. Home-exercise program for another 3x/week.; Nutritional optimization with a high-protein oral supplement, along with nutritional counseling and access to a Registered Dietitian on site.; Anxiety reduction workshop and take-home anxiety reduction program.	Combination product: Trimodal Prehab & ERP; 1-hr daily exercise will be completed a total of 5d/week, of which 2 of these sessions are completed through a community fitness center. Following these sessions, the participant will consume a high-protein oral supplement. Additionally, during the program, participants will be given the option of attending a stress-reduction group and will receive a take-home anxiety-reduction program. They will have access to a physiotherapist, kinesiologist, registered dietitian, and physician throughout the program. The total length of this program is 8-weeks and is timed to occur in the waiting period between the consent for surgery and operation date.; Other Names: Trimodal prehab and enhanced-recovery pathway (ERP) together
ACTIVE_COMPARATOR: No Prehab; ERP Alone; The active comparator group will be given a home exercise program, nutrition education, and a take-home anxiety reduction program.	Other: No Prehab; ERP Alone; 1-hr daily exercise with a self-completed home-exercise program. The participant will be given nutritional education material and a take-home anxiety-reduction program. They will be responsible for maintaining a journal of their activity.; Other Names: No trimodal prehab; enhanced-recovery pathway (ERP) alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk test (6MWT)	The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.	Multiple time-points over 20-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-meter walk test (10mWT)	The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.	Multiple time-points over 20-weeks
30s sit-to-stand test (30CST)	The 30CST is a measurement that assesses functional lower extremity strength in older adults. It is part of the Fullerton Functional Fitness Test Battery. This test was developed to overcome the floor effect of the 5 or 10 repetition sit to stand test in older adults.	Multiple time-points over 20-weeks
Hand-grip dynamometry	A quantitative and objective measure of isometric muscular strength of the hand and forearm, predictive of overall upper-extremity function.	Multiple time-points over 20-weeks
Functional Assessment of Cancer Therapy for Bladder Cancer (FACT-Bl)Questionnaire	A reliable and valid questionnaire that comprehensively assesses quality of life concerns pertinent to bladder cancer patients.	Collected at beginning and end of 20-week participant involvement period
EuroQOL five dimensions (EQ-5D) Questionnaire	A short, generic quality of life questionnaire	Collected at beginning and end of 20-week participant involvement period
Godin Leisure Time Exercise Questionnaire	A short questionnaire on self-reported physical activity.	Collected at beginning and end of 20-week participant involvement period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay (LOS)	Length of stay in the hospital starting from post-operative day #0 and terminating when the participant is discharged from the hospital.	Collected at the finale of participant-involvement (20-weeks)
30 day readmission rate	Number of participants re-admitted to hospital within 30 days of discharge as a percentage of the total number of participants involved in the study.	Collected at the finale of participant-involvement (20-weeks)
Clavien-Dindo classification of Surgical Complications	A classification scheme that objectively grades surgical complications using a descriptive grading system.	Collected at the finale of participant-involvement (20-weeks)

Collaborators and Investigators

• Sponsor: Jason Martyn
• Collaborators: Alberta Health services; University of Alberta; University of Calgary; Physiotherapy Alberta - College + Association
• Investigators: Principal Investigator: Jason Martyn, MScPT, Alberta Health Services

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 15, 2018
• Primary Completion (ANTICIPATED): January 15, 2019
• Study Completion (ANTICIPATED): July 15, 2019

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (ACTUAL): November 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: nutrition; physiotherapy; prehabilitation; enhanced recovery after surgery; cystectomy
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 2017CRIF-JMARTYN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No