Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care

Not Applicable

• Conditions: Bladder Cancer; Nutrition Aspect of Cancer
• Interventions: Other: No Prehab; ERP Alone; Combination Product: Trimodal Prehab & ERP

• Registration Number: NCT03347045
• Lead Sponsor: Jason Martyn

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-16
• Last Update Submitted: 2017-11-16
• Study First Posted: 2017-11-20
• Last Update Posted: 2017-11-20
• Study Start: 2018-01-15
• Primary Completion: 2019-01-15
• Study Completion: 2019-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Prehab; ERP Alone	No Prehab; ERP Alone	The active comparator group will be given a home exercise program, nutrition education, and a take-home anxiety reduction program.
Trimodal Prehab & ERP	Trimodal Prehab & ERP	Trimodal prehab includes: 1. Guided exercise program at Repsol Place in Calgary, Alberta 2x/week, hosted by the Total Cardiology group. Home-exercise program for another 3x/week. 2. Nutritional optimization with a high-protein oral supplement, along with nutritional counseling and access to a Registered Dietitian on site. 3. Anxiety reduction workshop and take-home anxiety reduction program.

Primary Outcome Measures

Name	Time	Method
6-minute walk test (6MWT)	Multiple time-points over 20-weeks	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.

Secondary Outcome Measures

Name	Time	Method
30s sit-to-stand test (30CST)	Multiple time-points over 20-weeks	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.
Hand-grip dynamometry	Multiple time-points over 20-weeks	A quantitative and objective measure of isometric muscular strength of the hand and forearm, predictive of overall upper-extremity function.
10-meter walk test (10mWT)	Multiple time-points over 20-weeks	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.
Functional Assessment of Cancer Therapy for Bladder Cancer (FACT-Bl)Questionnaire	Collected at beginning and end of 20-week participant involvement period	A reliable and valid questionnaire that comprehensively assesses quality of life concerns pertinent to bladder cancer patients.
EuroQOL five dimensions (EQ-5D) Questionnaire	Collected at beginning and end of 20-week participant involvement period	A short, generic quality of life questionnaire
Godin Leisure Time Exercise Questionnaire	Collected at beginning and end of 20-week participant involvement period	A short questionnaire on self-reported physical activity.