Superficial Bladder CancerNCT03091764
Evaluation of a Patient-Reported Symptom Index for NMIBC
An observational study of Superficial Bladder Cancer, run by University of Sydney at 19 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Bladder Cancer
- How many people
- 498 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 1 Jul 2016to 30 Aug 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- newly diagnosed NMIBC
- Adult (>18yrs)
Show all 9Show fewer
- 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
Who cannot join
- 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:
Show all 12Show fewer
- 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
- currently undergoing active treatment for any bladder cancer, or finished treatment within last 3 years.
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
Australia12 sites
Box Hill Hospital
Box Hill, Victoria, 3128
Concord Hospital
Concord, New South Wales, 2139
Austin Health
Heidelberg, Victoria, 3084
Alfred Health
Melbourne, Victoria, 3004
Monash Health
Moorabbin, Victoria, 3189
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Royal Melbourne Hospital
Parkville, Victoria, 3052
Mater Misericordiae Limited
South Brisbane, Queensland, 4101
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, 2650
The Urological Cancer Centre, Westmead Specialist Centre
Westmead, New South Wales, 2145
Westmead Hospital
Westmead, New South Wales, 2145
United States3 sites
University of Kansas
Kansas City, Kansas, 66160
University of Minnesota
Minneapolis, Minnesota, 55455
Mayo Clinic
Rochester, Minnesota, 55905
New Zealand2 sites
Canterbury Urology Research Trust
Christchurch, 8013
Tauranga Urology Research
Tauranga, 3140
United Kingdom1 site
Salford Royal NHS Foundation Trust
Salford, Manchester, M5 5AP
About this study
Official title: Psychometric Evaluation of a Patient-Reported Symptom Index for Non-Muscle Invasive Bladder Cancer: Field Testing
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.
Read the detailed description
The overarching aim of this research is to develop and evaluate a patient-reported Symptom Index (SI) for individuals with NMIBC (the NMIBC-SI) that is acceptable to patients, reliable, valid and responsive, and fit for purpose in clinical trials and clinical practice.
Specific clinical aims:
- Assess and compare key Patient-Reported Outcomes (PROs) across the full range of contemporary treatments for NMIBC, and over the disease trajectory including acute treatment and 1year survivorship;
- Compare PROs between patients with low, intermediate, and high risk NMIBC.
In field test 1, 200 participants will complete one questionnaire either in hard copy (pencil and paper) or online, at a time that is convenient for the participant. The questionnaire may take up to 20 minutes to complete.
In field test 2, 250 participants will complete quality of life questionnaires at four different time points; 1) before tumour resection, 2) 1 week after resection, 3) 8 weeks after resection, and 4) 1 year after resection. The questionnaires can be completed in the clinic or at home, either in hard copy (pencil and paper) or online, at a time that is convenient for the participant but still within the relevant time point. The questionnaires may take up to 30 minutes to complete.
- Conditions
- Superficial Bladder Cancer
- Keywords
- NMIBC, non-muscle invasive bladder cancer, Patient reported outcome, Symptom burden, Questionnaire
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NMIBC-SI development and validation
non-muscle invasive bladder cancer symptom index (questionnaire being developed and evaluated in this study)
Measured: Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal)
Secondary outcomes (3)
QLQC-30
EORTC cancer quality of life questionnaire
Measured: Field test 2: four time-points over 1 year
NMIBC24
EORTC superficial bladder cancer questionnaire
Measured: Field test 2: four time-points over 1 year
NMIBC-SI long term
non-muscle invasive bladder cancer symptom index (long-term follow-up, and differences between groups)
Measured: Field test 2: four time-points over 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start1 Jul 2016
- Primary completion30 Jul 2020
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Superficial Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 498 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Cancer Australia, Cancer Council New South Wales
- Responsible party
- Sponsor
- Investigators
- Manish Patel, MBBS,PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091764
- Sponsor's protocol ID
- APP1103036
- Status last verified
- Oct 2021
- First submitted
- 21 Mar 2017
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29117930
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Evaluation of a Patient-Reported Symptom Index for Non-Muscle Invasive Bladder Cancer: Field Testing
- ClinicalTrials.gov ID
- NCT03091764
- Acronym / sponsor ID
- APP1103036
- Conditions
- Superficial Bladder Cancer
- Keywords
- NMIBC, non-muscle invasive bladder cancer, Patient reported outcome, Symptom burden, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Cancer Australia, Cancer Council New South Wales
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overarching aim of this research is to develop and evaluate a patient-reported Symptom Index (SI) for individuals with NMIBC (the NMIBC-SI) that is acceptable to patients, reliable, valid and responsive, and fit for purpose in clinical trials and clinical practice.
Specific clinical aims:
- Assess and compare key Patient-Reported Outcomes (PROs) across the full range of contemporary treatments for NMIBC, and over the disease trajectory including acute treatment and 1year survivorship;
- Compare PROs between patients with low, intermediate, and high risk NMIBC.
In field test 1, 200 participants will complete one questionnaire either in hard copy (pencil and paper) or online, at a time that is convenient for the participant. The questionnaire may take up to 20 minutes to complete.
In field test 2, 250 participants will complete quality of life questionnaires at four different time points; 1) before tumour resection, 2) 1 week after resection, 3) 8 weeks after resection, and 4) 1 year after resection. The questionnaires can be completed in the clinic or at home, either in hard copy (pencil and paper) or online, at a time that is convenient for the participant but still within the relevant time point. The questionnaires may take up to 30 minutes to complete.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
- newly diagnosed NMIBC
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NMIBC-SI development and validation
Time frame: Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal)
non-muscle invasive bladder cancer symptom index (questionnaire being developed and evaluated in this study)
3 secondary outcomes
QLQC-30
Time frame: Field test 2: four time-points over 1 year
NMIBC24
Time frame: Field test 2: four time-points over 1 year
NMIBC-SI long term
Time frame: Field test 2: four time-points over 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Background: PubMed 29117930Rutherford 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manish Patel, MBBS,PhD principal investigator
University of Sydney
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superficial Bladder Cancer, run by University of Sydney at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Australia, United States, New Zealand, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NMIBC-SI development and validation (time frame: Field test 1: once only (cross-sectional). Field test 2: baseline to post-treatment (longitudinal)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03091764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.