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Clinical Trials/NCT06694142
NCT06694142
Not yet recruiting
Not Applicable

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

The University of Texas Health Science Center, Houston1 site in 1 country20 target enrollmentNovember 18, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sexual Dysfunction
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
20
Locations
1
Primary Endpoint
Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI)
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 18, 2024
End Date
May 18, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lavanya Palavalli Parsons

Assistant Professor

The University of Texas Health Science Center, Houston

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).

Outcomes

Primary Outcomes

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

Time Frame: Baseline, 6 months

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 sexual dysfunction as assessed by the Social Determinants of Health (SDOH) questionnaire

Time Frame: Baseline, 6 months

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

Secondary Outcomes

  • Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in ethnic minority groups(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(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(end of study (6 months after baseline))

Study Sites (1)

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