Bladder Cancer, Urothelial Carcinoma
Conditions
Keywords
Bladder Cancer, Urothelial Carcinoma, Chemotherapy, Neoadjuvant, Exercise prehabilitation
Brief summary
The purpose of this study is to explore the feasibility and efficacy of a 12-week, home-based exercise program in bladder cancer patients undergoing curative intent neoadjuvant chemotherapy and RC.
Detailed description
The investigators will seek to recruit 20 patients diagnosed with muscle invasive localized urothelial carcinoma of the bladder who are scheduled to receive neo-adjuvant chemotherapy prior to RC from the Queen Elizabeth Health Sciences center in Halifax, Nova Scotia. Participants will be randomly allocated to standard of care treatment versus standard of care plus a multimodal, home-based program including strength and endurance exercises. Outcomes measured will include feasibility data, patient outcomes, and post-surgical complications.
Interventions
BEHAVIORALExercise program
As per the intervention arm
Sponsors
Nova Scotia Health Authority
Ross Mason
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. confirmed diagnosis of localized muscle invasive urothelial carcinoma of the bladder (clinical stages cT2-4a, N0-1, M0); 2. treatment plan includes the administration of cisplatin-based systemic neoadjuvant chemotherapy prior to anticipated RC (typically four, 3-week cycles of cisplatin-based chemotherapy); 3. English fluency; 4. physician approval; and 5. participant willingness to participate in a 12-week, home-based exercise intervention.
Exclusion criteria
1. unstable or symptomatic cardiac or pulmonary disease, musculoskeletal injury or co-morbid disease that precludes ability to exercise; and 2. significant cognitive limitations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 12 weeks | Fatigue as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-F). The FACIT-F is a 13 item scale with each item measured on a 4-point Likert scale. The total score ranges from 0 to 52. High scores represent less fatigue. |
| Health-related quality of life in patients with bladder cancer | 12 weeks | Health-related quality of life during neoadjuvant chemotherapy as measured using the Functional Assessment of Cancer Therapy - Bladder scale (FACT-Bl). The 39 item FACT-B provides subscale scores of physical (7-items), functional (7-items), emotional (6-items), and social/family (7-items) well-being as well as a bladder cancer specific sub-scale. The sum of scores on subscales evaluates a participants' quality of life with higher scores denoting higher quality of life. |
| Sleep quality | 12 weeks | Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 19-item tool that assesses usual sleep habits during the past month. A global sleep quality score from 0 to 21 is generated with higher scores denoting worse sleep quality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative length of stay | 30 days post-surgery | Post-operative length of stay measured as the number of days from surgery until initial discharge from hospital |
| Post-surgical complications | 30 days post-surgery | Post-surgical complications will be assessed using the Clavien-Dindo grading system |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chemotherapy completion rates | 16 weeks | Chemotherapy completion rate measured as the percentage of patients completing four cycles of neoadjuvant chemotherapy |
| Post-surgical readmission rates | 90 days post-surgery | Post-surgical readmission rates as defined by any readmission to hospital within 90 days of surgery |
Outcome results
None listed