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NCT Number: NCT06694142

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.

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Key information

Conditions

Sexual Dysfunction Genital Diseases Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayokunle Ogunye

CONTACT

[email protected]

(713) 500-6410

Lavanya P Parsons, MD

CONTACT

[email protected]

(713) 500-6440

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 19, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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