NCT04223063

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

December 18, 2019

Last Update Submit

January 7, 2020

Conditions

Bladder CancerUrothelial Carcinoma

Keywords

Bladder CancerUrothelial CarcinomaChemotherapyNeoadjuvantExercise prehabilitation

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Post-surgical complications

    30 days post-surgery

  • Post-operative length of stay

    30 days post-surgery

Other Outcomes (2)

  • Chemotherapy completion rates

    16 weeks

  • Post-surgical readmission rates

    90 days post-surgery

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Exercise programBEHAVIORAL

As per the intervention arm

Also known as: Multimodal, home-based exercise program
Exercise Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • unstable or symptomatic cardiac or pulmonary disease, musculoskeletal injury or co-morbid disease that precludes ability to exercise; and
  • significant cognitive limitations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder NeoplasmsCarcinoma, Transitional Cell

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Urology

Study Record Dates

First Submitted

December 18, 2019

First Posted

January 10, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2022

Last Updated

January 10, 2020

Record last verified: 2020-01