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

NCT06694142 | Not Yet Recruiting

• 1 other identifier: HSC-MS-24-0817
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction

Keywords

breast and gynecologic cancer patients

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 6 months

• 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

  Baseline, 6 months

Secondary Outcomes (3)

• 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 Arms (1)

Rosy app

EXPERIMENTAL

Behavioral: Rosy app

Interventions

Rosy app BEHAVIORAL

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.

Rosy app

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Lavanya P Parsons, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lavanya P Parsons, MD

CONTACT

(713) 500-6440; Lavanya.H.PalavalliParsons@uth.tmc.edu

Ayokunle Ogunye

CONTACT

(713) 500-6410; Ayokunle.Ogunye@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 19, 2024
• Study Start: November 18, 2024
• Primary Completion: November 18, 2025
• Study Completion: May 18, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)