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Not yet recruiting NCT06694142

Feasibility of Addressing Sexual Dysfunction in Women with Breast and Gynecologic Cancers with a Novel Mobile Application

No phase Interventional Sexual Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rosy app.
Who it may be relevant to
Registry conditions: Sexual Dysfunction. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Not Always ROSY-Feasibility of Addressing Sexual Dysfunction in Women with Breast and Gynecologic Cancers with a Novel Mobile Application

Overview

The purpose of this study is to identify breast and gynecologic cancer patients with sexual dysfunction, to measure sexual dysfunction with the Female Sexual Function Index (FSFI) and to provide Patients with the opportunity during this six-month period to follow up with a healthcare provider to discuss the sexual dysfunction needs and to see if a medical intervention can be of aid.

Interventions

  • Behavioral Rosy app
    Participants will be provided a six-month membership subscription to the mobile application ROSY. ROSY will recommend pathways for addressing issues through 1) coaching by board certified coaches or 2) joining a completely anonymous community with other people where they can share experiences and get help as new members of the community to overcome sexual health challenges .Users will work towards their health goals each day using tools from medical and mental health experts . Tools used include

Primary outcome measures

  • Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) [Time frame: Baseline, 6 months]
  • Change in sexual dysfunction as assessed by the Social Determinants of Health (SDOH) questionnaire [Time frame: Baseline, 6 months]
Secondary outcome measures (3)
  • Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in ethnic minority groups [Time frame: end of study (6 months after baseline)]
  • Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in sexual and gender minority groups [Time frame: end of study (6 months after baseline)]
  • Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in unpartnered women [Time frame: end of study (6 months after baseline)]

Eligibility criteria

Inclusion criteria

  • Patient with a current or historic diagnosis of breast cancer or gynecologic cancer (uterine ovarian, fallopian tube, peritoneal, cervical, vulva, or vaginal cancers)
  • Agree to participate in the study with completion of survey and use of ROSY mobile application

Exclusion criteria

  • Currently pregnant
  • Non-English speaking (ROSY is currently is only available is in English).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06694142 · HSC-MS-24-0817

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗