RECRUITING

Development of a New Canadian Endourology Group Stent Symptom Score

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Placement of a ureteral stent is a common urological intervention. For decades there was no valid measures available to assess quality of life issues in patients with ureteral stents, which has hampered the understanding of such symptoms and their true impact. In order to improve the outcomes associated with the placement of a stent, a validated tool is needed to measure its impact and the amount of undesirable effects it produces on patients requiring the placement of a stent. In 2003, the team of the Bristol Urological Institute developed a validated questionnaire called the: URETERAL STENT SYMPTOM QUESTIONNAIRE (USSQ). The questionnaire contains 38 items included in 6 sections. Despite the obvious need of a validated questionnaire, the latter remains unused by the community of peer urologists. Many of urologists consider it too long to be used in clinical practice and even for research purposes. This issue motivated the Canadian Endourology Group (CEG) to work collaboratively on the development of the CANADIAN ENDOUROLOGY GROUP STENT SYMPTOM SCORE (CEGSSS) in order to provide clinicians with a more useful and validated tool. To fulfill this objective, the CEG proceeds in three phases. Phase 1. A systematic, deliberative, and participatory approach mostly through face to face meetings, including patients, clinicians, and researchers in the field of Endourology to identify a minimum needs-based set of domains and items that are, clinically relevant to be included in the CEGSSS in order to ensure optimal uptake in the clinical setting. Phase 2. A pilot study to assess feasibility/acceptability and further refine the proposed set of items selected in phase 1 of the study. Phase 3. A multicentric prospective study to evaluate the validity, reliability and sensitivity to change of the CEGSSS. This research project is conducted by the Canadian Endourology Group (CEG), a panel of experts in the field of endourology in Canada. The CEG is a national member-based organization dedicated to enabling the profession to provide the highest possible standards of endourological care and to advance the science of endourology by collaboratively: 1. Fostering excellence in endourological practice through advocacy, education, research and practice support tools, 2. Leading evidence-based clinical practice through the development of practice standards and guidelines in endourology, 3. Providing continuous professional development for Canadian endourologists along the career-path continuum, 4. Providing leadership in public education for endourological conditions.

Official Title

Canadian Endourology Group Stent Symptom Score: Development and Validation of A New Questionnaire

Quick Facts

Study Start:2022-05-15
Study Completion:2025-09-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04909541

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Patient with ureteral stent
  3. * Ability to communicate in English
  1. * Inability to provide an informed consent due to physical or mental inability
  2. * Active malignancy
  3. * Obstruction
  4. * Long-term stent (\>2 weeks)

Contacts and Locations

Study Contact

Naeem Bhojani, MD
CONTACT
514-890-8000
naeem.bhojani@gmail.com
Kahina Bensaadi, DESS
CONTACT
514-890-8000
kahina.bensaadi.chum@ssss.gouv.qc.ca

Principal Investigator

Naeem Bhojani, MD
PRINCIPAL_INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)

Study Locations (Sites)

University of California, Los Angeles
Los Angeles, California, 90095
United States
Cleveland Clinic - University of Toronto.
Mayfield Heights, Ohio, 44124
United States

Collaborators and Investigators

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

  • Naeem Bhojani, MD, PRINCIPAL_INVESTIGATOR, Centre hospitalier de l'Université de Montréal (CHUM)

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 Registration Dates

Study Start Date2022-05-15
Study Completion Date2025-09-15

Study Record Updates

Study Start Date2022-05-15
Study Completion Date2025-09-15

Terms related to this study

Additional Relevant MeSH Terms

  • Urologic Diseases