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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06694142
Enrollment
20
Registered
2024-11-19
Start date
2024-11-18
Completion date
2026-05-18
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Dysfunction

Keywords

breast and gynecologic cancer patients

Brief summary

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

BEHAVIORALRosy 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 1) virtual workshops and 2) coaching sessions which will provide the opportunity to a) Have an authentic and relatable conversation with an expert b) Explore new pathways to better health experience c) Improve their relationship with themselves, partner, and healthcare providers d) Learn fun ways to improve their everyday wellness e) Access live events from anywhere.

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI)Baseline, 6 monthsFSFI is a 19-item instrument that measures 6 domains of sexual function: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. This uses a Likert-type scale, with scores ranging from 0 to 5, except for questions 1, 2, 13, and 16, which are scored from 1 to 5. The total score ranges from 2.0 to 36.0, with higher scores indicating better functioning.
Change in sexual dysfunction as assessed by the Social Determinants of Health (SDOH) questionnaireBaseline, 6 monthsscore ranges from 0 to 10, higher score showing worse outcome

Secondary

MeasureTime frameDescription
Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in ethnic minority groupsend of study (6 months after baseline)FSFI is a 19-item instrument that measures 6 domains of sexual function: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. This uses a Likert-type scale, with scores ranging from 0 to 5, except for questions 1, 2, 13, and 16, which are scored from 1 to 5. The total score ranges from 2.0 to 36.0, with higher scores indicating better functioning.
Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in sexual and gender minority groupsend of study (6 months after baseline)FSFI is a 19-item instrument that measures 6 domains of sexual function: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. This uses a Likert-type scale, with scores ranging from 0 to 5, except for questions 1, 2, 13, and 16, which are scored from 1 to 5. The total score ranges from 2.0 to 36.0, with higher scores indicating better functioning.
Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in unpartnered womenend of study (6 months after baseline)FSFI is a 19-item instrument that measures 6 domains of sexual function: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. This uses a Likert-type scale, with scores ranging from 0 to 5, except for questions 1, 2, 13, and 16, which are scored from 1 to 5. The total score ranges from 2.0 to 36.0, with higher scores indicating better functioning.

Countries

United States

Contacts

Primary ContactLavanya P Parsons, MD
Lavanya.H.PalavalliParsons@uth.tmc.edu(713) 500-6440
Backup ContactAyokunle Ogunye
Ayokunle.Ogunye@uth.tmc.edu(713) 500-6410

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026