Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000972224
Ethics application status
Approved
Date submitted
9/11/2009
Date registered
10/11/2009
Date last updated
28/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An international field study of the reliability and validity of a proctitis specific quality of life module (European Organisation for Research and Treatment of Cancer Quality of Life Module for Proctitis-23 items (EORTC QLQ-PRT23))
Scientific title
An international field study of the reliability and validity of a proctitis specific quality of life module (European Organisation for Research and Treatment of Cancer Quality of Life Module for Proctitis-23 items (EORTC QLQ-PRT23))
Secondary ID [1] 295934 0
Nil known
Universal Trial Number (UTN)
U1111-1112-4462
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
All cancers located in pelvic region treated with radiation therapy 252156 0
Condition category
Condition code
Cancer 252354 252354 0 0
Prostate
Cancer 252355 252355 0 0
Womb (Uterine or endometrial cancer)
Cancer 252356 252356 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Plan of Investigation
The primary objective of Phase IV of the study will be to test the scale structure, reliability and validity and cross-cultural applicability of the proctitis module (EORTC QLQ-PRT23) to be used alone or together with the EORTC Quality of Life Questionnaire (EORTC QLQ-C30) in patients who are receiving radiation therapy to their pelvic region.

Participants
Patients will be recruited from collaborating hospitals in Australia, Norway, Germany, Italy and France. This will enable the testing of the questionnaire in Anglo-Saxon countries, Northern Europe and Southern Europe.

We aim to recruit patients who have received a curative dose of radiation therapy to their pelvic region (50-70Gy). This will include tumours located in the following sites: prostate, cervix and rectum. Patients will be eligible for the study if they are receiving a radical course of pelvic irradiation (50-70 Gy) and able to converse freely in the language that the questionnaire is written. Participants will be ineligible for the study if they have previously received radiation therapy, the radiation dose prescribed is less than 50 Gy and they are participating in other Quality of Life trials that might interfere with this study.

Trial Design
This is a cross-sectional longitudinal descriptive study, which collects Quality of Life data alongside socio-demographic and clinical background data at three time points during the patients’ radiation therapy treatment. The following time points will be used to test for acute proctitis:
1. At least two (2) weeks prior to radiotherapy treatment (when they see their clinician);
2. During the first (1st) week of treatment;
3. At the end of treatment;
4. At the three (3) to six (6) months scheduled follow-up appointment, after treatment completion.

Patients will be asked to complete the first questionnaire when they are seeing their clinician during a routine visit. On subsequent occasions the questionnaire will be either provided when they present for treatment or alternatively posted to them with reply paid envelopes so that patients can post these questionnaires back to them.

Administration of the questionnaire at these time points will facilitate evaluation of how the patients’ experiences of acute proctitis change as they proceed through treatment. Socio-demographic details collected will include age, geographical location, education and clinical background data will include diagnosis, tumour site and radiation dose prescribed. Patients will be stratified by treating centre and tumour site.

A second group of participants will be asked to complete questionnaires at two time points once treatment is complete to measure chronic proctitis. The time points used will be
1. When patient is experiencing ‘moderate to severe’ symptoms;
2. When patient is experiencing ‘minor to mild’ symptoms.


Patients who participate in the study will be asked to complete a demographics questionnaire, the EORTC QLQ-C30 and the proctitis module (EORTC QLQ-PRT23). They will then be asked to respond to the following questions as recommended by the EORTC quality of life group:
a) How long did it take you to complete the questionnaire?
b) Did anyone help you to complete the questionnaire?
c) Were there questions that you found confusing or difficult to answer?
d) Were there questions that you found upsetting?
The clinicians involved in treating these patients and identifying them for the study will be asked to complete the EORTC Tadiation Therapy Oncology Group classification system for each patient at each time point.

Data collection will occur over a period of three years.
Intervention code [1] 241523 0
Not applicable
Intervention code [2] 241529 0
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253230 0
Proctitis symptoms will be measured using the proctitis module developed (EORTC PRT-23)

Proctitis is an unpleasant recurrent clinical syndrome that is manifest by bouts of the following symptoms: anorectal pain, profuse rectal bleeding or blood clots, explosive bowel urgency, frequent diarrhoea, profuse mucous discharge, faecal and/or mucous incontinence
Timepoint [1] 253230 0
Prior to radiation therapy
During first week of treatment
Completion of treatment
Post treatment (3-6 months)
Secondary outcome [1] 262185 0
N/A
Timepoint [1] 262185 0
N/A

Eligibility
Key inclusion criteria
Receiving a curative dose of radiation therapy to pelvis (50-70Gy)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be ineligible for the study if they have previously received radiation therapy, the radiation dose prescribed is less than 50 Gy

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2010
Actual
22/04/2010
Date of last participant enrolment
Anticipated
Actual
16/10/2013
Date of last data collection
Anticipated
Actual
5/05/2014
Sample size
Target
350
Accrual to date
Final
358
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2316 0
Germany
State/province [1] 2316 0
Country [2] 2317 0
France
State/province [2] 2317 0
Country [3] 2318 0
Italy
State/province [3] 2318 0
Country [4] 2319 0
Norway
State/province [4] 2319 0
Country [5] 20811 0
Canada
State/province [5] 20811 0
Quebec

Funding & Sponsors
Funding source category [1] 243996 0
Other Collaborative groups
Name [1] 243996 0
European Organisation for Research and Treatment of Cancer (EORTC)
Country [1] 243996 0
Belgium
Primary sponsor type
Other Collaborative groups
Name
EORTC Quality of Life Group
Address
Avenue Emmanuel Mounier 83
1200 Brussels
Belgium
Country
Belgium
Secondary sponsor category [1] 251348 0
None
Name [1] 251348 0
Address [1] 251348 0
Country [1] 251348 0
Other collaborator category [1] 950 0
Hospital
Name [1] 950 0
Sir Charles Gairdner Hospital
Address [1] 950 0
Hospital Avenue, Nedlands, Western Australia, 6009
Country [1] 950 0
Australia
Other collaborator category [2] 951 0
University
Name [2] 951 0
Curtin University of Technology
Address [2] 951 0
GPO Box U1987, Perth, WA, 6845
Country [2] 951 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244102 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 244102 0
Sir Charles Gairdner Hospital,
Hospital Avenue, Nedlands, 6009
Ethics committee country [1] 244102 0
Australia
Date submitted for ethics approval [1] 244102 0
22/10/2009
Approval date [1] 244102 0
26/11/2009
Ethics approval number [1] 244102 0
2009-141
Ethics committee name [2] 301320 0
Royal Perth Hospital
Ethics committee address [2] 301320 0
Department of Health
Government of Western Australia
South Metropolitan Area Health Service
Room 5105 Level, 5 Colonial House
Ethics committee country [2] 301320 0
Australia
Date submitted for ethics approval [2] 301320 0
21/03/2011
Approval date [2] 301320 0
04/04/2011
Ethics approval number [2] 301320 0
RA-11/010
Ethics committee name [3] 301321 0
Centre Hospitalier Universitaire de Sherbrooke
Ethics committee address [3] 301321 0
Hopital Fleurimont
3001, 12e Avenue Nord
Bureau Z5-3014
Sherbrooke (Quebec) J1H 5N4
Ethics committee country [3] 301321 0
Canada
Date submitted for ethics approval [3] 301321 0
Approval date [3] 301321 0
13/12/2011
Ethics approval number [3] 301321 0
11-146
Ethics committee name [4] 301322 0
Comite De Protection Des Personnes
Ethics committee address [4] 301322 0
CHU de Grenoble
Comite de Protection des Personnes
B P 217
38043 Grenoble
Vedex 9
Ethics committee country [4] 301322 0
France
Date submitted for ethics approval [4] 301322 0
Approval date [4] 301322 0
Ethics approval number [4] 301322 0
Ethics committee name [5] 301323 0
Axienda Sanitaria Locale Br
Ethics committee address [5] 301323 0
Via Napoli, n. 8 - 72011 Brindisi (Casale)
Ethics committee country [5] 301323 0
Italy
Date submitted for ethics approval [5] 301323 0
Approval date [5] 301323 0
29/09/2010
Ethics approval number [5] 301323 0
Ethics committee name [6] 301324 0
Regional komite for medisinsk og helsefaglig forskningsetikk REK midt-Norge (REK midt)
Ethics committee address [6] 301324 0
Ethics committee country [6] 301324 0
Norway
Date submitted for ethics approval [6] 301324 0
Approval date [6] 301324 0
27/10/2011
Ethics approval number [6] 301324 0

Summary
Brief summary
This is a cross-sectional longitudinal descriptive study, which collects Quality of Life data alongside socio-demographic and clinical background data for 2 types of proctitis (chronic and acute) at different time points during the patients’ radiation therapy treatment. The same questionnaire will be used for both chronic and acute proctitis.
Trial website
http://groups.eortc.be/qol/questionnaires_modules.htm
Trial related presentations / publications
G Halkett, S Aoun, D Hayne, J-A Lund, A Gruen, J Villa, L Livi, S Arcangeli, G Velikova, N Spry, On behalf of EORTC Quality of Life Group. EORTC radiation proctitis-specific quality of life module – Pretesting in four European countries. Radiotherapy and Oncology, 2010 97:294-300. doi:10.1016/j.radonc.2010.04.001

GKB Halkett, M Short, S Aoun, D Joseph, S Bydder, X Meng, N Spry. What pelvic radiation disease symptoms are experienced by patients receiving external beam radiotherapy and a high-dose-rate brachytherapy boost for prostate cancer? 2017 9(5):393-402. https://doi.org/10.5114/jcb.2017.70731

G Halkett, CA Wigley, S Aoun, M Portaluri, F Tramacere, L Livi, B Detti, S Arcangeli, J-A Lund, A Kristensen, N McFadden, A Grun, S Bydder, I Sackerer, E Greimel, N Spry, on behalf of the EORTC Quality of Life Group. International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: a phase IV study. Radiation Oncology (in press August 2018).
Public notes

Contacts
Principal investigator
Name 30482 0
Dr Georgia Halkett
Address 30482 0
Faculty of Health Sciences,
Curtin University
7 Parker Place, Technology Park, Bentley WA 6102
GPO Box U1987, Perth WA 6845
Western Australia
Country 30482 0
Australia
Phone 30482 0
618 9266 1762
Fax 30482 0
618 9266 2508
Email 30482 0
g.halkett@curtin.edu.au
Contact person for public queries
Name 13729 0
Dr Dr Georgia Halkett
Address 13729 0
WA Centre for Cancer and Palliative Care
Curtin University of Technology
Health Research Campus
GPO Box U1987, Perth, WA, 6845
Country 13729 0
Australia
Phone 13729 0
618 9266 1762
Fax 13729 0
618 9266 2508
Email 13729 0
g.halkett@curtin.edu.au.au
Contact person for scientific queries
Name 4657 0
Dr Dr Georgia Halkett
Address 4657 0
WA Centre for Cancer and Palliative Care
Curtin University of Technology
Health Research Campus
GPO Box U1987, Perth, WA, 6845
Country 4657 0
Australia
Phone 4657 0
618 9266 1762
Fax 4657 0
618 9266 2508
Email 4657 0
g.halkett@curtin.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInternational validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: A phase IV study.2018https://dx.doi.org/10.1186/s13014-018-1107-x
N.B. These documents automatically identified may not have been verified by the study sponsor.