Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorCandiolo Cancer Institute - IRCCS

About this trial

Primary objectives:

* To estimate Sexual Dysfunction (SD) incidence in premenopausal breast cancer patients treated by surgery and taking endocrine therapy. * To detect the presence of SD-related distress in the population, as a determining factor in the maintenance of a good quality of life.

Secondary objectives:

* To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens. * Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

women aged ≥18 and ≤ 55

who underwent surgery for early stage breast cancer

taking endocrine therapy for at least 3 months

providing an informed consent and completing the study questionnaires.

Disqualifiers

withdrawal of the informed consent, at any time

Trial population

Women aged ≥18 and ≤ 55 who underwent surgery for early stage breast cancer, taking endocrine therapy for at least 3 months

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Questionnaire

    Other intervention

    none, it's a incidence-prevalence study

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Patients1 intervention
Group B: Controls1 intervention

Trial outcomes

Primary outcomes

1

Sexual Dysfunction (SD) incidence

To estimate Sexual Dysfunction (SD) incidence (physiological parameter) in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.

Time frame
6 months
2

SD-related distress

To detect the presence of SD-related distress (physiological parameter) in the population, as a determining factor in the maintenance of a good quality of life.

Time frame
6 months

Secondary outcomes

1

SD characteristics

To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens.

Time frame
6 months
2

Collect baseline data

Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.

Time frame
6 months

Other outcomes

Sponsors and contacts

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