Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care
TPC-RCT
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2017
CompletedFirst Posted
Study publicly available on registry
November 20, 2017
CompletedStudy Start
First participant enrolled
January 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2019
CompletedNovember 20, 2017
November 1, 2017
1 year
November 14, 2017
November 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
10-meter walk test (10mWT)
Multiple time-points over 20-weeks
30s sit-to-stand test (30CST)
Multiple time-points over 20-weeks
Hand-grip dynamometry
Multiple time-points over 20-weeks
Functional Assessment of Cancer Therapy for Bladder Cancer (FACT-Bl)Questionnaire
Collected at beginning and end of 20-week participant involvement period
EuroQOL five dimensions (EQ-5D) Questionnaire
Collected at beginning and end of 20-week participant involvement period
- +1 more secondary outcomes
Other Outcomes (3)
Length of hospital stay (LOS)
Collected at the finale of participant-involvement (20-weeks)
30 day readmission rate
Collected at the finale of participant-involvement (20-weeks)
Clavien-Dindo classification of Surgical Complications
Collected at the finale of participant-involvement (20-weeks)
Study Arms (2)
Trimodal Prehab & ERP
EXPERIMENTALTrimodal 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.
No Prehab; ERP Alone
ACTIVE COMPARATORThe active comparator group will be given a home exercise program, nutrition education, and a take-home anxiety reduction program.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Male or female ≥ 18 years of age at time of consent for surgery.
- Documentation of bladder cancer diagnosis as evidenced by diagnostic imaging and biopsy.
- May or may not receive adjuvant therapy.
- Written informed consent obtained from subject
You may not qualify if:
- 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:
- American Society of Anesthesiologists (ASA) health class status 4-5;
- Co-morbid medical, physical, and/or mental conditions including dementia, disabling orthopedic and neuromuscular disease, psychosis;
- Severe cardiac abnormalities, end-stage organ disease, sepsis, or morbid obesity (BMI greater than 35);
- Undergoing radical cystectomy for a reason other than bladder cancer.
- Poor comprehension of English or French
- Screened by Total Cardiology staff and determined to be inappropriate for prehabilitation at their facility.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jason Martynlead
- Alberta Health servicescollaborator
- University of Calgarycollaborator
- Physiotherapy Alberta - College + Associationcollaborator
- University of Albertacollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Martyn, MScPT
Alberta Health services
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Assessor blinding; due to the nature of the study, participant, care provider \& investigator cannot be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Physiotherapist
Study Record Dates
First Submitted
November 14, 2017
First Posted
November 20, 2017
Study Start
January 15, 2018
Primary Completion
January 15, 2019
Study Completion
July 15, 2019
Last Updated
November 20, 2017
Record last verified: 2017-11