Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000633684
Ethics application status
Approved
Date submitted
6/06/2014
Date registered
17/06/2014
Date last updated
17/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Experiences of genitourinary symptoms in postmenopausal women receiving hormonal therapy for early stage breast cancer
Scientific title
PEGASUS - Prevalence and severity of genitourinary symptoms in postmenopausal women receiving adjuvant endocrine therapy for early stage breast cancer and impact on sexual function and quality of life: A prospective study
Secondary ID [1] 282972 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
PEGASUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 289793 0
genitourinary symptoms 289794 0
endocrine therapy 289795 0
sexual dysfunction 289796 0
quality of life 289797 0
Condition category
Condition code
Cancer 290148 290148 0 0
Breast
Renal and Urogenital 292480 292480 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 292481 292481 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
PEGASUS is a multi-centre prospective study looking at the potential impact of adjuvant endocrine therapy on genitourinary symptoms in postmenopausal women who are about to commence either tamoxifen (TAM) or aromatase inhibitors (AIs) and then follow their trajectory over time (up to 2 years). It is a questionnaire-based study and as such, women will be asked to complete self-administered questionnaires at baseline (prior to the commencement of endocrine therapy), and 6-, 12- and 24-month follow-ups.
Intervention code [1] 287678 0
Not applicable
Comparator / control treatment
We are comparing baseline symptoms (when no adjuvant endocrine therapy is being taken) versus overtime symptoms (when endocrine therapy is being received). In addition, we are comparing symptoms between different types of endocrine therapy (i.e tamoxifen versus aromatase Inhibitors).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290177 0
1/2 standard deviation in mean International Consultation on Incontinence Questionnaire on Female Lower Urinary Tract Symptom (ICIQ-FLUTS) sub-domain scores that corresponds to a difference in severity of 1 level on a single question in the ICIQ-FLUTS questionnaire.
Timepoint [1] 290177 0
Baseline, and at 6, 12 and 24 months after baseline.
Primary outcome [2] 290178 0
Mean International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS) score.
Timepoint [2] 290178 0
Baseline, and at 6, 12 and 24 months after baseline
Secondary outcome [1] 304058 0
Pain intensity during intercourse using Visual Analogue Scale Pain Assessment of Dyspareunia (VAS-DYSPAR)
Timepoint [1] 304058 0
Baseline, and at 6, 12 and 24 months after baseline
Secondary outcome [2] 304059 0
Sexual function associated with urinary symptoms using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) short form
Timepoint [2] 304059 0
Baseline, and at 6, 12 and 24 months after baseline
Secondary outcome [3] 304060 0
Subjective hormone-related symptoms using the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) subscale
Timepoint [3] 304060 0
Baseline, and at 6, 12 and 24 months after baseline
Secondary outcome [4] 304061 0
General quality of life using the EQ-5D a short generic health-related quality of life instrument that consists of two parts: a self-classifier and a Visual Analogue Scale (EQ VAS).
Timepoint [4] 304061 0
Baseline, and at 6, 12 and 24 months after baseline

Eligibility
Key inclusion criteria
Eligible participants for this study will include postmenopausal women at diagnosis, with early stage breast cancer and hormone receptor-positive tumours, prior to starting adjuvant endocrine therapy (TAM or AIs), are between 18 and 75 years inclusive and are sufficiently competent in English to be able to complete questionnaires written in English.

Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include women with locally recurrent cancer or metastatic disease, current use of hormonal replacement therapy (including vaginal oestrogen) and lack of fluency in English as study participation will involve the completion of self-administered questionnaires.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This project is powered to detect a relatively small difference in the prevalence of genitourinary symptoms in postmenopausal women taking TAM and those taking AIs as adjuvant endocrine therapy for breast cancer. Urinary symptoms will be assessed by the ICIQ-FLUTS. We defined a clinically meaningful difference in ICIQ-FLUTS sub-domain scores as 1/2 standard deviation that corresponded to a difference in severity of 1 level on a single question in the questionnaire. Sample size calculations were performed utilising a 2 group comparison of the difference in mean ICIQ-FLUTS' scores between the two treatment groups (tamoxifen versus aromatase inhibitors). We determined that 210 and 70 patients who have been on aromatase inhibitors and tamoxifen respectively will be needed for a two-sided alpha error of 0.05 and a power 80%. A total of 280 postmenopausal women with oestrogen receptor positive breast cancer will be recruited to the study. Data will be analysed using SPSS 21.0 (Statistical Program for the Social Sciences). Bivariate associations between the outcome variable and possible confounders will first be examined, using Kendall’s rank correlation or Pearson’s product correlation coefficient, as appropriate, for continuous variables, using t-tests of Mann-Whitney U tests, as appropriate, where one variable is continuous and the other is binary, and using chi-squared tests where both outcome and predictor variable are binary. Bivariate analyses will be followed by repeated measures multilevel or hierarchical linear or logistic regressions (depending on the outcome of tests for normality) with time as the repeated measures factor. The outcome variable will be dichotomized if its distribution is too far from normal. If the data suggest a need to adjust for confounding variables (such as age, BMI, parity, smoking) or include moderating variables (e.g. group status), these will be included as covariates and/or interaction terms. The regression analyses will be undertaken using multilevel (or hierarchal) modelling, which is tolerant of missing data, in that one missing observation does not mean that the whole case is lost.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2013
Actual
21/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 289264 0
Self funded/Unfunded
Name [1] 289264 0
None
Country [1] 289264 0
Primary sponsor type
University
Name
University of New South Wales Australia
Address
UNSW Australia, High Street, Kensington, NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 287938 0
None
Name [1] 287938 0
None
Address [1] 287938 0
None
Country [1] 287938 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study is investigating the prevalence and severity of genitourinary symptoms in postmenopausal women receiving adjuvant endocrine therapy for early stage breast cancer and the impact on sexual function and quality of life.

Who is it for?
You may be eligible to joint this study if you are a postmenopausal female, aged 18 -75 years, with early stage breast cancer and hormone receptor-positive tumours, for which you are about to commence adjuvant endocrine therapy with either tamoxifen (TAM) or aromatase inhibitors (AIs). You will need to be sufficiently competent in English in order to complete the study questionnaires.

Study details
All participants in this study are asked to complete self-administered questionnaires at baseline (prior to starting endocrine therapy), and 6-, 12- and 24-month follow-ups. The standardised questionnaires used relate to genitourinary symptoms, sexual function and quality of life.

The findings from this study could be used to identify patients at risk of developing genitourinary symptoms and also to offer appropriate interventions early to prevent and ameliorate such symptoms which are likely to have a negative impact on quality of life and may contribute to a low compliance with treatment. We believe that this study has the potential to document the extent and impact of genitourinary symptoms in breast cancer survivors about to start adjuvant endocrine therapy and what happens over time. It will also lead to intervention studies in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42010 0
Dr Mariana Sousa
Address 42010 0
Psychosocial Research Group
Level4, C25 Lowy Cancer Research Centre
UNSW Australia, Sydney NSW 2052
Country 42010 0
Australia
Phone 42010 0
+610299850024
Fax 42010 0
+610299850033
Email 42010 0
[email protected]
Contact person for public queries
Name 42011 0
Dr Mariana Sousa
Address 42011 0
Psychosocial Research Group
Level4, C25 Lowy Cancer Research Centre
UNSW Australia, Sydney NSW 2052
Country 42011 0
Australia
Phone 42011 0
+610299850024
Fax 42011 0
+610299850033
Email 42011 0
[email protected]
Contact person for scientific queries
Name 42012 0
Dr Mariana Sousa
Address 42012 0
Psychosocial Research Group
Level4, C25 Lowy Cancer Research Centre
UNSW Australia, Sydney NSW 2052
Country 42012 0
Australia
Phone 42012 0
+610299850024
Fax 42012 0
+610299850033
Email 42012 0
[email protected]

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
No additional documents have been identified.