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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Currently pregnant

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Rosy appExperimental treatment 1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: