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

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ClinicalTrials.gov Identifier: NCT04223063
Recruitment Status : Not yet recruiting
First Posted : January 10, 2020
Last Update Posted : January 10, 2020
Sponsor:
Collaborator:
Nova Scotia Health Authority
Information provided by (Responsible Party):
Ross Mason, Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Urothelial Carcinoma Behavioral: Exercise program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exercise-based Pre-habilitation in Bladder Cancer Patients Prior to Radical Cystectomy: a Feasibility Study
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
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.
Behavioral: Exercise program
As per the intervention arm
Other Name: Multimodal, home-based exercise program

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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 Outcome Measures :
  1. Post-surgical complications [ Time Frame: 30 days post-surgery ]
    Post-surgical complications will be assessed using the Clavien-Dindo grading system

  2. 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


Other Outcome Measures:
  1. Chemotherapy completion rates [ Time Frame: 16 weeks ]
    Chemotherapy completion rate measured as the percentage of patients completing four cycles of neoadjuvant chemotherapy

  2. Post-surgical readmission rates [ Time Frame: 90 days post-surgery ]
    Post-surgical readmission rates as defined by any readmission to hospital within 90 days of surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Ross Mason, Assistant Professor of Urology, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT04223063    
Other Study ID Numbers: 21485
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ross Mason, Nova Scotia Health Authority:
Bladder Cancer
Urothelial Carcinoma
Chemotherapy
Neoadjuvant
Exercise prehabilitation
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases