Sexuality After Breast Cancer

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2011
INTERVENTION: First silicone‐based lubricant then water‐based lubricant or First water‐based lubricant then silicone‐based lubricant. Both lubricants are safe and available and widely used as over the counter preparations. Participants should apply a small amount of lubricant around the entrance of the vagina prior to sexual activity or intercourse. Each lubricant will be used as determined by the user for 1 month before changing to the alternative lubricant. There will be no washout period between lubricants. CONDITION: Vaginal dryness PRIMARY OUTCOME: To compare the efficacy and acceptablility of a silicone‐based vaginal lubricant vs. a water‐based lubricant in breast cancer patients with symptomatic vaginal dryness using a randomised AB/BA cross‐over design. We will evaluate vaginal dryness using both subjective and objective measures. The vaginal Health Assessment will be assessed by the study doctor and Sexual Activity Questionnaire (SAQ) Discomfort subscale complete by the participant. We will evaluate discomfort at intercourse using objective measures. The Sexual Activity Questionnaire (SAQ) Discomfort subscale and Female Intervention Efficay Index (FIEI). We will evaluate sexual activity using a sexual activity diary and patient perceived efficacy will be measured using standardised and validated scales (sexual Activity Questionnaire (SAQ) Discomfort subscale , the Female Intervention Efficay Index (FIEI) SECONDARY OUTCOME: To evaluate sexual function and quality of life using the Sexual Activity Questionnaire, general quality of life using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT‐B), endocrine symptoms using the Functional Assessment of cancer Therapy for Patients with Endocrine Symptoms (FACT‐ES, and distress using the Female Sexual Distress Scale‐Revised. We will assess vaginal condition using a standardised visual method and patient acceptability of the products. Since anxiety and depression after breast cancer may also affect sexual function, we will measure these factors using the standardised Hospital Anxiety and Depression Scale (HADS). INCLUSION CRITERIA: History of breast cancer Sexually active and symptoms of vaginal dryness or dyspareunia Will to be randomised to try both products Willing to complete daily sexual activity diary Normal pap smear in last 2 years if retains uterus
Epistemonikos ID: d04efff9a003253f2e078fb1aa502198b0e69415
First added on: Aug 22, 2024