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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2021

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

  • Behavioral: Exercise program
    • As per the intervention arm

Arms, Groups and Cohorts

  • Experimental: Exercise Intervention
    • Participants allocated to the exercise intervention will engage in a multimodal, home-based program including strength and endurance exercises. Participants will initially be seen in person and instructed to begin a moderate-intensity (i.e., 3-4 on 10-point Borg Scale) walking (or preferred aerobic exercise) program for a minimum of 30 minutes/day, 3-5 days/week and perform strength exercises at least 2 days/week.
  • No Intervention: Control
    • Participants allocated to the control group will not receive any formal exercise prescription or guidance, however they will be offered the opportunity to participate in a home-based intervention pending the completion of data collection.

Clinical Trial Outcome Measures

Primary Measures

  • Health-related quality of life in patients with bladder cancer
    • Time Frame: 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.
  • Fatigue
    • Time Frame: 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.
  • Sleep quality
    • Time Frame: 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 Measures

  • Post-surgical complications
    • Time Frame: 30 days post-surgery
    • Post-surgical complications will be assessed using the Clavien-Dindo grading system
  • Post-operative length of stay
    • Time Frame: 30 days post-surgery
    • Post-operative length of stay measured as the number of days from surgery until initial discharge from hospital

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ross Mason
  • Collaborator
    • Nova Scotia Health Authority
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Ross Mason, Assistant Professor of Urology – Nova Scotia Health Authority

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