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

Not Applicable

Recruiting

• Conditions: breast cancer; genitourinary symptoms; endocrine therapy; sexual dysfunction; quality of life; Cancer - Breast; Renal and Urogenital - Other renal and urogenital disorders; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12614000633684
• Lead Sponsor: niversity of New South Wales Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 280

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. [Baseline, and at 6, 12 and 24 months after baseline.];Mean International Consultation on Incontinence Questionnaire on Vaginal Symptoms (ICIQ-VS) score.[Baseline, and at 6, 12 and 24 months after baseline]

Secondary Outcome Measures

Name	Time	Method
Pain intensity during intercourse using Visual Analogue Scale Pain Assessment of Dyspareunia (VAS-DYSPAR)<br>[Baseline, and at 6, 12 and 24 months after baseline];Sexual function associated with urinary symptoms using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) short form[Baseline, and at 6, 12 and 24 months after baseline];Subjective hormone-related symptoms using the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) subscale[Baseline, and at 6, 12 and 24 months after baseline];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). [Baseline, and at 6, 12 and 24 months after baseline]