CClinicalTrials.gg
Not yet recruitingNCT06694142Updated Nov 19, 2024

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

An interventional study of Rosy app in Sexual Dysfunction, sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-19.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Sexual Dysfunction

Keywords

  • breast and gynecologic cancer patients
03

In context

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

Exclusion Criteria:

  • Currently pregnant
  • Non-English speaking (ROSY is currently is only available is in English).
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Rosy app

    Behavioral: Rosy app

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.

06

What researchers measure

Primary outcomes

  1. Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI)

    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.

    Time frame: Baseline, 6 months

  2. Change in sexual dysfunction as assessed by the Social Determinants of Health (SDOH) questionnaire

    score ranges from 0 to 10, higher score showing worse outcome

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in ethnic minority groups

    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.

    Time frame: end of study (6 months after baseline)

  2. Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in sexual and gender minority groups

    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.

    Time frame: end of study (6 months after baseline)

  3. Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in unpartnered women

    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.

    Time frame: end of study (6 months after baseline)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06694142
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Lavanya Palavalli Parsons (Assistant Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Nov 19, 2024
Start date
Nov 18, 2024 (estimated)
Primary completion
Nov 18, 2025 (estimated)
Completion
May 18, 2026 (estimated)
Last update
Nov 19, 2024

Study contacts

Lavanya P Parsons, MD
Contact
Lavanya.H.PalavalliParsons@uth.tmc.edu
(713) 500-6440
Ayokunle Ogunye
Contact
Ayokunle.Ogunye@uth.tmc.edu
(713) 500-6410
Lavanya P Parsons, MD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion