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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614000633684

Acronym

PEGASUS

Enrollment

280

Registered

2014-06-17

Start date

2013-05-21

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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 (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 follo

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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.

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.

Outcome results