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

Jason Martyn

Status: Unknown

Conditions: Bladder Cancer; Nutrition Aspect of Cancer

Treatments: Combination Product: Trimodal Prehab & ERP; Other: No Prehab; ERP Alone

Study type: Interventional

Funder types: Other

Identifiers

NCT03347045

2017CRIF-JMARTYN

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Trimodal Prehab & ERP

Experimental group

Description:

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.

Treatment:

Combination Product: Trimodal Prehab & ERP

No Prehab; ERP Alone

Active Comparator group

Description:

The active comparator group will be given a home exercise program, nutrition education, and a take-home anxiety reduction program.

Treatment:

Other: No Prehab; ERP Alone