RecruitingACTRN12614000633684

Experiences of genitourinary symptoms in postmenopausal women receiving hormonal therapy for early stage breast cancer

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


Sponsor

University of New South Wales Australia

Enrollment

280 participants

Start Date

May 21, 2013

Study Type

Observational

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Women who take hormone-blocking medications for breast cancer — such as tamoxifen or aromatase inhibitors — often experience uncomfortable symptoms in the urinary and genital area, including dryness, pain during sex, and urinary problems. These symptoms can significantly affect quality of life. This study is tracking how common and severe these symptoms are over two years in women who have just started these medications, to help doctors identify those at risk early and offer better support. You may be eligible if: - You are a postmenopausal woman between 18 and 75 years old - You have been diagnosed with early stage, hormone receptor-positive breast cancer - You are about to start adjuvant endocrine therapy (tamoxifen or an aromatase inhibitor) - You have sufficient English skills to complete questionnaires You may NOT be eligible if: - You have locally recurrent or metastatic (spread) breast cancer - You are currently using hormonal replacement therapy, including vaginal oestrogen - You do not speak English fluently Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 (

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.


Locations(1)

NSW,VIC, Australia

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ACTRN12614000633684