Clinical trial NCT03347045: Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care
Official title: Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Nutrition Aspect of Cancer
Keywords: cystectomy
nutrition
physiotherapy
prehabilitation
enhanced recovery after surgery
Lead sponsor: Alberta Health Services, Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health services
name: University of Calgary
name: Physiotherapy Alberta - College + Association
name: University of Alberta
First posted: 2017-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center pragmatic randomized-control trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 6-minute walk test (6MWT)
timeFrame: Multiple time-points over 20-weeks
Secondary outcomes:
measure: 10-meter walk test (10mWT)
timeFrame: Multiple time-points over 20-weeks
measure: 30s sit-to-stand test (30CST)
timeFrame: Multiple time-points over 20-weeks
measure: Hand-grip dynamometry
timeFrame: Multiple time-points over 20-weeks
measure: Functional Assessment of Cancer Therapy for Bladder Cancer (FACT-Bl)Questionnaire
timeFrame: Collected at beginning and end of 20-week participant involvement period
measure: EuroQOL five dimensions (EQ-5D) Questionnaire
timeFrame: Collected at beginning and end of 20-week participant involvement period
measure: Godin Leisure Time Exercise Questionnaire
timeFrame: Collected at beginning and end of 20-week participant involvement period
Other outcomes:
measure: Length of hospital stay (LOS)
timeFrame: Collected at the finale of participant-involvement (20-weeks)
measure: 30 day readmission rate
timeFrame: Collected at the finale of participant-involvement (20-weeks)
measure: Clavien-Dindo classification of Surgical Complications
timeFrame: Collected at the finale of participant-involvement (20-weeks)
Locations:
Study officials:
affiliation: Alberta Health services
name: Jason Martyn, MScPT
role: PRINCIPAL_INVESTIGATOR
References: