NCT03091764

Brief Summary

This project will develop and evaluate a patient-reported symptom index to assess the impact of treatment for non-muscle invasive bladder cancer on patient burden, toxicity, symptoms and side effects. The symptom index will provide a method for assessing treatments from the patient's perspective; help healthcare professionals make better informed treatment decisions, and provide a method to be able to effectively evaluate treatments for non-muscle invasive bladder cancer.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
498

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
5 countries

19 active sites

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

Study Start

First participant enrolled

July 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

October 13, 2021

Status Verified

October 1, 2021

Enrollment Period

4.1 years

First QC Date

March 21, 2017

Last Update Submit

October 11, 2021

Conditions

Superficial Bladder Cancer

Keywords

NMIBCnon-muscle invasive bladder cancerPatient reported outcomeSymptom burdenQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • NMIBC-SI development and validation

    non-muscle invasive bladder cancer symptom index (questionnaire being developed and evaluated in this study)

    Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal)

Secondary Outcomes (3)

  • QLQC-30

    Field test 2: four time-points over 1 year

  • NMIBC24

    Field test 2: four time-points over 1 year

  • NMIBC-SI long term

    Field test 2: four time-points over 1 year

Study Arms (3)

NMIBC Patient High Risk

Any of the following: * T1 tumours * CIS (carcinoma in situ) * Multiple and recurring and large (\>3cm) Ta, G1, G2 tumours (all these conditions must be presented) (Patients requiring intravesical Bacillus Calmette-Guérin (BCG) (immunotherapy), which starts with 6 week induction treatment and continues with maintenance for 1 to 3 years)

NMIBC Patient Intermediate Risk

All cases between High and Low Risk (Patients requiring intravesical therapy which lasts between 6 weeks to 3 years)

NMIBC Patient Low Risk

Primary, solitary, Ta, LG/G1, \<3cm, no CIS (Patients receiving frequent cystoscopies, possible tumour resections and single instillations of postoperative chemotherapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (aged ≥18 years) from participating centres diagnosed with NMIBC, able to read and understand English, and give their written informed consent will be included in the study.

You may qualify if:

  • diagnosed NMIBC
  • Adult (\>18yrs)
  • able to read and understand English
  • undergoing active treatment (i.e. one week after tumour resection or intravesical therapy) or completed final treatment for NMIBC within the last week

You may not qualify if:

  • unconscious or confused
  • have cognitive impairment
  • unable to speak, read and/or write in English
  • diagnosed with muscle invasive disease
  • unable to provide informed consent
  • Field test 2:
  • newly diagnosed NMIBC
  • Adult (\>18yrs)
  • able to read and understand English
  • after imaging or flexible cystoscopy, and before active treatment
  • either before endoscopic resection, or more than 4 weeks since endoscopic resection, but before active/ongoing treatment
  • unconscious or confused
  • have cognitive impairment
  • unable to speak, read and/or write in English
  • diagnosed with muscle invasive disease
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

University of Kansas

Kansas City, Kansas, 66160, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Concord Hospital

Concord, New South Wales, 2139, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Riverina Cancer Care Centre

Wagga Wagga, New South Wales, 2650, Australia

Location

The Urological Cancer Centre, Westmead Specialist Centre

Westmead, New South Wales, 2145, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Mater Misericordiae Limited

South Brisbane, Queensland, 4101, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Monash Health

Moorabbin, Victoria, 3189, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3052, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

Canterbury Urology Research Trust

Christchurch, 8013, New Zealand

Location

Tauranga Urology Research

Tauranga, 3140, New Zealand

Location

Salford Royal NHS Foundation Trust

Salford, Manchester, M5 5AP, United Kingdom

Location

Related Publications (1)

  • Rutherford C, King MT, Smith DP, Costa DS, Tait MA, Patel MI; NMIBC-SI Working Group. Psychometric Evaluation of a Patient-Reported Symptom Index for Nonmuscle Invasive Bladder Cancer: Field Testing Protocol. JMIR Res Protoc. 2017 Nov 8;6(11):e216. doi: 10.2196/resprot.8761.

    PMID: 29117930BACKGROUND

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrinary Bladder NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Manish Patel, MBBS,PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 27, 2017

Study Start

July 1, 2016

Primary Completion

July 30, 2020

Study Completion

August 30, 2021

Last Updated

October 13, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(12)CA(1)US(3)NZ(2)GB(1)