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

November 16, 2024 updated by: Lavanya Palavalli Parsons, The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosy app
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 months
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
Baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
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)
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.
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)
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.
end of study (6 months after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Lavanya P Parsons, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 18, 2024

Primary Completion (Estimated)

November 18, 2025

Study Completion (Estimated)

May 18, 2026

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 16, 2024

First Posted (Estimated)

November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 16, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSC-MS-24-0817

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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