Bladder Cancer
Conditions
Keywords
Non-muscle invasive bladder cancer, Exercise, High-intensity interval training, Randomized Controlled Trial
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.
Interventions
OTHERHigh-Intensity Interval Training
The intervention will be performed on a treadmill and will include a warm-up and cool-down at 50-60% and 40% of the VO2peak respectively, for up to five minutes. The HIIT protocol will be 4x4, which consists of four bouts of four minutes at a workload corresponding to vigorous intensity (75-95% of the baseline and 6-week VO2peak) alternating with three minutes of recovery intervals at 40% of the VO2peak. The exercise session will last 35 minutes and include 16 minutes of high intensity exercise.
Sponsors
Northern Alberta Urology Centre
Cross Cancer Institute
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and investigators will not be blinded to group assignment given the nature of the intervention. Outcome assessors will be blinded to group assignment for the clinical outcomes of tumour recurrence and progression.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Functional 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 average |
| Fear 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/progression |
| Anxiety | 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 anxiety |
| Depression | 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 depression |
| 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 stress |
| Fatigue | 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 fatigue |
| 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-esteem |
| Sleep 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 |
| Social 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 |
| Lower 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 average |
| 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 average |
| Lower 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 average |
| Upper 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 average |
| Agility | 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 average |
| Anthropometry and body composition measurements | At baseline, after the intravesical therapy (6-week), and 3-month follow-up | Height, weight, waist, hip, and calf circumference |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment toxicities | 6-week follow-up | Treatment toxicities will be abstracted from medical records |
| Incidence of Adverse events related to the High-Intensity Interval Training during Intravesical Therapy | Through study completion, an average of 1 year | To evaluate the safety of the program, any adverse events during the physical assessments (baseline, post- intravesical therapy, and post-intervention) and during the exercise sessions will be recorded. |
| Eligibility rate of non-muscle invasive bladder cancer patients to a high-intensity interval | At baseline | The eligibility rate will be the number of non-muscle invasive bladder cancer patients |
| Recruitment rate of non-muscle invasive bladder cancer patients to a high-intensity interval training during Intravesical Therapy | At baseline | The recruitment rate will be the number of non-muscle invasive bladder cancer patients enrolled in the study divided by the number of eligible patients. |
| Adherence rate of non-muscle invasive bladder cancer patients to a high-intensity interval | Through exercise intervention completion, an average of 12-weeks | Adherence to the program will be measured by the number of exercise sessions completed without dose modifications. Reasons for not completing the exercise session or for dose adjustments will be recorded. |
| Follow-up assessment rate of non-muscle invasive bladder cancer patients to a high-intensity interval program during Intravesical Therapy | After the intravesical therapy (6-week), at the 3-month follow-up, and at 1 year follow-up | The follow-up assessment rate will be determined by the number of participants who do not complete the post-intervention or follow-up assessments for any reason. |
| Intravesical therapy adherence | 6-week follow-up | Intravesical therapy adherence will be tracked by medical records of attendance and self-report drug retention time |
| Complete response | 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy) and one-year follow-up | Negative cytology, imaging, and cystoscopy and, when the TURBT is indicated, a negative biopsy. |
Countries
Canada
Outcome results
None listed