Exercise-based Pre-habilitation in Bladder Cancer Patients Prior to Radical Cystectomy: a Feasibility Study

Bladder Cancer Clinical Trial

Official title:

Exercise-based Pre-habilitation in Bladder Cancer Patients Prior to Radical Cystectomy: a Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04223063
• Other study ID #: 21485
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: March 2022

Study information

• Verified date: January 2020
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2022
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms
• Urothelial Carcinoma

Intervention

Behavioral:
• Exercise program
As per the intervention arm

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ross Mason	Nova Scotia Health Authority

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chemotherapy completion rates	Chemotherapy completion rate measured as the percentage of patients completing four cycles of neoadjuvant chemotherapy	16 weeks
Other	Post-surgical readmission rates	Post-surgical readmission rates as defined by any readmission to hospital within 90 days of surgery	90 days post-surgery
Primary	Health-related quality of life in patients with bladder cancer	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.	12 weeks
Primary	Fatigue	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.	12 weeks
Primary	Sleep quality	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	12 weeks
Secondary	Post-surgical complications	Post-surgical complications will be assessed using the Clavien-Dindo grading system	30 days post-surgery
Secondary	Post-operative length of stay	Post-operative length of stay measured as the number of days from surgery until initial discharge from hospital	30 days post-surgery