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