NCT03462667

Brief Summary

The purpose of this study is to learn if the stoma boot camp is a good and effective way to help people adapt to life with a stoma after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 23, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

February 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

1.4 years

First QC Date

February 23, 2018

Last Update Submit

September 8, 2020

Conditions

Stoma Ileostomy

Outcome Measures

Primary Outcomes (1)

  • Ostomy adjustment scale

    The Ostomy Adjustment Scale evaluates a person with an ostomy following surgery. The instrument consists of 34 statements. Scores range from a minimum of 34 to a maximum of 204. The higher the score, the better the person's perceived adjustment.

    Change from Baseline to 30 Days After Date of Surgery

Secondary Outcomes (2)

  • Length of hospital stay

    Date of Admission to Date of Discharge, up to 7 days

  • Count of un-planned stoma-related interventions in community after discharge

    30 Days After Date of Surgery

Study Arms (2)

Stoma Boot Camp

EXPERIMENTAL

Participants will attend the Stoma Boot Camp session prior to surgery.

Behavioral: Stoma Boot Camp

Regular Care

ACTIVE COMPARATOR

Participants will receive normal standard of care prior to surgery.

Other: Standard of Care

Interventions

Stoma Boot CampBEHAVIORAL

Educational session designed to prepare people for living life with a stoma.

Stoma Boot Camp
Standard of CareOTHER

Patients receive normal pre-surgery standard of care.

Regular Care

Eligibility Criteria

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

You may qualify if:

  • Patients must be presumed to undergo a radical cystectomy with ileal conduit diversion
  • Diagnosis of bladder cancer

You may not qualify if:

  • Patients undergoing a radical cystectomy with ileal conduit for any reason other than bladder cancer will not be allowed to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Moben Mirza, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 12, 2018

Study Start

February 26, 2018

Primary Completion

August 1, 2019

Study Completion

March 1, 2020

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

US(1)