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

Primary Purpose

Bladder Cancer, Urothelial Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise program
Sponsored by
Ross Mason
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bladder Cancer focused on measuring Bladder Cancer, Urothelial Carcinoma, Chemotherapy, Neoadjuvant, Exercise prehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Exercise Intervention

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 18, 2019
    Last Updated
    January 7, 2020
    Sponsor
    Ross Mason
    Collaborators
    Nova Scotia Health Authority
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04223063
    Brief Title
    Exercise-based Pre-habilitation in Bladder Cancer Patients Prior to Radical Cystectomy: a Feasibility Study
    Official Title
    Exercise-based Pre-habilitation in Bladder Cancer Patients Prior to Radical Cystectomy: a Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2020 (Anticipated)
    Primary Completion Date
    March 2021 (Anticipated)
    Study Completion Date
    March 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ross Mason
    Collaborators
    Nova Scotia Health Authority

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bladder Cancer, Urothelial Carcinoma
    Keywords
    Bladder Cancer, Urothelial Carcinoma, Chemotherapy, Neoadjuvant, Exercise prehabilitation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise program
    Other Intervention Name(s)
    Multimodal, home-based exercise program
    Intervention Description
    As per the intervention arm
    Primary Outcome Measure Information:
    Title
    Health-related quality of life in patients with bladder cancer
    Description
    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.
    Time Frame
    12 weeks
    Title
    Fatigue
    Description
    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.
    Time Frame
    12 weeks
    Title
    Sleep quality
    Description
    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
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Post-surgical complications
    Description
    Post-surgical complications will be assessed using the Clavien-Dindo grading system
    Time Frame
    30 days post-surgery
    Title
    Post-operative length of stay
    Description
    Post-operative length of stay measured as the number of days from surgery until initial discharge from hospital
    Time Frame
    30 days post-surgery
    Other Pre-specified Outcome Measures:
    Title
    Chemotherapy completion rates
    Description
    Chemotherapy completion rate measured as the percentage of patients completing four cycles of neoadjuvant chemotherapy
    Time Frame
    16 weeks
    Title
    Post-surgical readmission rates
    Description
    Post-surgical readmission rates as defined by any readmission to hospital within 90 days of surgery
    Time Frame
    90 days post-surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: confirmed diagnosis of localized muscle invasive urothelial carcinoma of the bladder (clinical stages cT2-4a, N0-1, M0); treatment plan includes the administration of cisplatin-based systemic neoadjuvant chemotherapy prior to anticipated RC (typically four, 3-week cycles of cisplatin-based chemotherapy); English fluency; physician approval; and participant willingness to participate in a 12-week, home-based exercise intervention. Exclusion Criteria: unstable or symptomatic cardiac or pulmonary disease, musculoskeletal injury or co-morbid disease that precludes ability to exercise; and significant cognitive limitations.

    12. IPD Sharing Statement

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