Bladder Cancer and exeRcise Training During intraVesical thErapy
- Conditions
- Bladder Cancer
- Interventions
- Other: High-Intensity Interval Training
- Registration Number
- NCT04593862
- Lead Sponsor
- University of Alberta
- Brief Summary
Bladder cancer is the fifth most common cancer in Canada and has the eighth highest cancer mortality rate. The treatment for the most frequent type of bladder cancer is surgically removing the tumour followed by six weeks of medication placed within the bladder. There are physical and psychosocial challenges from bladder cancer and its treatment that may affect how patients feel and function, and consequently their quality of life. Moreover, bladder cancer patients are at a high risk of their bladder cancer coming back and getting worse. Exercise is a low-cost intervention that may lower the chances of bladder cancer coming back or getting worse, manage side effects related to treatment, help patients feel better, and improve quality of life. To date, however, no study has examined if it is safe or even possible for bladder cancer patients to exercise when they are receiving drugs placed into their bladder. The Bladder cancer and exeRcise trAining during intraVesical thErapy (BRAVE) Trial will be the first study to test the safety, feasibility, and efficacy of exercise in bladder cancer patients during this drug therapy. The investigators will ask some patients to do a supervised exercise program during their drug treatment while other patients will be asked not to exercise. The investigators will compare the 2 groups on how they fare with their bladder cancer treatment. This study will provide information on whether exercise may help patients feel better, function better, and possibly even lower their chances of the disease coming back or getting worse.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
- Eligible participants will include men and women that (1) are ≥ 18 years old, (2) have a confirmed diagnosis of non-muscle invasive bladder cancer (clinical stage cis, Ta or T1), and (3) are scheduled to receive induction intravesical therapy with chemotherapy (e.g., Gemcitabine or Mitomycin) or immunotherapy (e.g., BCG) agents.
- Exclusion criteria for participants include: (1) not being medically cleared to participate in the exercise intervention by their treating urologist and a certified exercise physiologist using the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+), (2) having contraindications for cardiopulmonary stress and/or physical fitness tests, (3) already exercising according to the Godin Leisure-Time Exercise Questionnaire (GLTEQ), (4) not having the ability to read and comprehend English, and (5) not willing to be randomized to a supervised exercise training program or usual care (no exercise) for 12 weeks.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise Group High-Intensity Interval Training The exercise intervention will consist of 36 high-volume high-intensity interval sessions over a 12-week period. The exercise frequency will be three times per week during the 6 weeks of intravesical therapy and the 6 weeks of recovery (total 12 weeks) prior to a surveillance cystoscopy.
- Primary Outcome Measures
Name Time Method Changes of Peak Oxygen Consumption (VO2peak) At baseline, after the intravesical therapy (6-week), and 3-month follow-up VO2 peak will be directly measured by the modified Bruce treadmill protocol exercise test, using a metabolic measurement system system (Parvo Medics TrueOne® 2400; Sandy, UT, USA).VO2peak will be defined as the highest oxygen-uptake value recorded during the test and will be expressed as relative to body mass (i.e., ml O2·kg-1·min-1).
- Secondary Outcome Measures
Name Time Method Health-related quality of life (HRQoL) At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up Assessment of health-related quality of life (HRQoL) using the European Organization for Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30) version 3.0.
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / quality of life scale, and six single items.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.Self-esteem At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up Self-esteem using the Rosenberg self-esteem scale
Minimum: 10 Maximum: 40 Higher score= better self-esteemLower body Flexibility At baseline, after the intravesical therapy (6-week), and 3-month follow-up Chair sit-and-reach
Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below averageFunctional Capacity At baseline, after the intravesical therapy (6-week), and 3-month follow-up 6-minute walk test
Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below averageFear of cancer recurrence/progression At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up Fear of cancer recurrence/progression will be assessed by the Fear of Cancer Recurrence Inventory
Minimum: 0 Maximum:168 Higher score= higher levels of fear of cancer recurrence/progressionAnxiety At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up Anxiety will be assessed using the 10-item State-trait Anxiety Inventory.
Minimum: 20 Maximum: 80 Higher score= worse anxietyFatigue At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire
Minimum: 0 Maximum: 52 Higher score=worse fatigueUpper body Flexibility At baseline, after the intravesical therapy (6-week), and 3-month follow-up Back Scratch
Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below averageLower body strength At baseline, after the intravesical therapy (6-week), and 3-month follow-up 30-second chair stand
Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below averageAnthropometry and body composition measurements At baseline, after the intravesical therapy (6-week), and 3-month follow-up Height, weight, waist, hip, and calf circumference
Perceived Stress At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire.
questionnaire.
Minimum: 0 Maximum: 56 Higher score=worse perceived stressSocial cognitive predictors of exercise adherence: motivation, perceived benefits, enjoyment, support from others, self-efficacy, and barriers At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up Standard scales for the Theory of Planned Behaviour
Bladder Cancer-Specific Quality of Life At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for non-muscle invasive bladder cancer core 24-item (EORTC QLQ NMIBC C24).
EORTC QLQ NMIBC C24 is composed of scales assessing urinary symptoms, bowel symptoms, sexual, and side effects of intravesical treatment (fever, malaise, convenience of and worry due to repeated cystoscopies).
All of the scales a range in score from 0 to 100. A high scale score represents a higher response level.Upper body strength At baseline, after the intravesical therapy (6-week), and 3-month follow-up Arm curl
Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below averageAgility At baseline, after the intravesical therapy (6-week), and 3-month follow-up 8-foot up-and-go
Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below averageDepression At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up Depression will be assessed using the Epidemiologic Studies Depression Scale (CES-D) questionnaire.
Minimum: 0 Maximum: 30 (cut off point: 10) Higher score= worse depressionSleep quality At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up Sleep quality will be assessed by the Insomnia Severity Index (ISI)
Minimum: 0 Maximum: 28 Higher score= worse insomnia
Trial Locations
- Locations (1)
Fernanda Zane Arthuso
🇨🇦Edmonton, Alberta, Canada