Bladder CancerTPC-RCTNCT03347045
Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care
A study testing Trimodal Prehab & ERP and No Prehab; ERP Alone in people with Bladder Cancer and Nutrition Aspect of Cancer, run by Jason Martyn.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Nutrition Aspect of Cancer
- What is being tested?
- Trimodal Prehab & ERP and No Prehab; ERP Alone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2018to 15 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Chelsia Gillis, PhD contact
About this study
Official title: 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.
Read more
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.
- Conditions
- Bladder Cancer, Nutrition Aspect of Cancer
- Being tested
- Trimodal Prehab & ERP, No Prehab; ERP Alone
- Keywords
- cystectomy, nutrition, physiotherapy, prehabilitation, enhanced recovery after surgery
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimodal Prehab & ERPCombination product
Also called Trimodal prehab and enhanced-recovery pathway (ERP) together
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.
No Prehab; ERP AloneOther
Also called No trimodal prehab; enhanced-recovery pathway (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.
| Study group | Role | What they receive |
|---|---|---|
| Trimodal Prehab & ERP | Experimental | 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. Receives: Combination Product: Trimodal Prehab & ERP |
| No Prehab; ERP Alone | Active comparator | The active comparator group will be given a home exercise program, nutrition education, and a take-home anxiety reduction program. Receives: Other: No Prehab; ERP Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Multiple time-points over 20-weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Collected at beginning and end of 20-week participant involvement period
EuroQOL five dimensions (EQ-5D) Questionnaire
A short, generic quality of life questionnaire
Measured: Collected at beginning and end of 20-week participant involvement period
Godin Leisure Time Exercise Questionnaire
A short questionnaire on self-reported physical activity.
Measured: Collected at beginning and end of 20-week participant involvement period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start15 Jan 2018 (estimated)
- Primary completion15 Jan 2019 (estimated)
- Study completion15 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center pragmatic randomized-control trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jason Martyn
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services, University of Calgary, Physiotherapy Alberta - College + Association, University of Alberta
- Responsible party
- Sponsor-investigator, Jason Martyn, Alberta Health Services, Calgary
- Investigators
- Jason Martyn, MScPT, Principal investigator, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347045
- Sponsor's protocol ID
- 2017CRIF-JMARTYN
- Acronym
- TPC-RCT
- Status last verified
- Nov 2017
- First submitted
- 14 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trimodal Prehabilitation for Cystectomy Patients to Enhance Post-operative Care: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03347045
- Acronym / sponsor ID
- TPC-RCT / 2017CRIF-JMARTYN
- Conditions
- Bladder Cancer, Nutrition Aspect of Cancer
- Keywords
- cystectomy, nutrition, physiotherapy, prehabilitation, enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jason MartynUniversity, hospital or other
- Collaborators
- Alberta Health services, University of Calgary, Physiotherapy Alberta - College + Association, University of Alberta
- Study start
- 15 Jan 2018 (estimated)
- Primary completion
- 15 Jan 2019 (estimated)
- Study completion
- 15 Jul 2019 (estimated)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center pragmatic randomized-control trial.
| Arm | Type | Receives |
|---|---|---|
| Trimodal Prehab & ERP | Experimental | Combination Product: Trimodal Prehab & ERPTrimodal 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 comparator | Other: No Prehab; ERP AloneThe active comparator group will be given a home exercise program, nutrition education, and a take-home anxiety reduction program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimodal Prehab & ERPAlso: Trimodal prehab and enhanced-recovery pathway (ERP) together1-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. | Combination product | Trimodal Prehab & ERP |
| No Prehab; ERP AloneAlso: No trimodal prehab; enhanced-recovery pathway (ERP) alone1-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 | No Prehab; ERP Alone |
Primary outcome
6-minute walk test (6MWT)
Time frame: 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.
6 secondary outcomes
10-meter walk test (10mWT)
Time frame: Multiple time-points over 20-weeks
30s sit-to-stand test (30CST)
Time frame: Multiple time-points over 20-weeks
Hand-grip dynamometry
Time frame: Multiple time-points over 20-weeks
Functional Assessment of Cancer Therapy for Bladder Cancer (FACT-Bl)Questionnaire
Time frame: Collected at beginning and end of 20-week participant involvement period
EuroQOL five dimensions (EQ-5D) Questionnaire
Time frame: Collected at beginning and end of 20-week participant involvement period
Godin Leisure Time Exercise Questionnaire
Time frame: Collected at beginning and end of 20-week participant involvement period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chelsia Gillis, PhD contact
Jason Martyn, MScPT principal investigator
Alberta Health services
Questions about this trial
What is this clinical trial studying?
A study testing Trimodal Prehab & ERP and No Prehab; ERP Alone in people with Bladder Cancer and Nutrition Aspect of Cancer, run by Jason Martyn.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Martyn, MScPT (403-943-3575, jason.martyn@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (6MWT) (time frame: Multiple time-points over 20-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.