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

January 7, 2020 updated by: Ross Mason
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-surgical complications
Time Frame: 30 days post-surgery
Post-surgical complications will be assessed using the Clavien-Dindo grading system
30 days post-surgery
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
30 days post-surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy completion rates
Time Frame: 16 weeks
Chemotherapy completion rate measured as the percentage of patients completing four cycles of neoadjuvant chemotherapy
16 weeks
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
90 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ross Mason

Collaborators

Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

January 7, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

January 10, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21485

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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