Sexual DysfunctionNCT06694142
Feasibility of Addressing Sexual Dysfunction in Women with Breast and Gynecologic Cancers with a Novel Mobile Application
A study testing Rosy app in people with Sexual Dysfunction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Dysfunction
- What is being tested?
- Rosy app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 18 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently pregnant
- Non-English speaking (ROSY is currently is only available is in English).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Lavanya P Parsons, MD, (713) 500-6440, Lavanya.H.PalavalliParsons@uth.tmc.edu
Ayokunle Ogunye, (713) 500-6410, Ayokunle.Ogunye@uth.tmc.edu
About this study
Official title: 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.
- Conditions
- Sexual Dysfunction
- Being tested
- Rosy app
- Keywords
- breast and gynecologic cancer patients
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosy appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Rosy app | Experimental | Not described Receives: Behavioral: Rosy app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: end of study (6 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start18 Nov 2024 (estimated)
- Primary completion18 Nov 2025 (estimated)
- Study completion18 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lavanya Palavalli Parsons, The University of Texas Health Science Center, Houston
- Investigators
- Lavanya P Parsons, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694142
- Sponsor's protocol ID
- HSC-MS-24-0817
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Not Always ROSY-Feasibility of Addressing Sexual Dysfunction in Women with Breast and Gynecologic Cancers with a Novel Mobile Application
- ClinicalTrials.gov ID
- NCT06694142
- Acronym / sponsor ID
- HSC-MS-24-0817
- Conditions
- Sexual Dysfunction
- Keywords
- breast and gynecologic cancer patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 18 Nov 2024 (estimated)
- Primary completion
- 18 Nov 2025 (estimated)
- Study completion
- 18 May 2026 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosy app | Experimental | Behavioral: Rosy app |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Currently pregnant
- Non-English speaking (ROSY is currently is only available is in English).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosy appParticipants 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. | Behavioural | Rosy app |
Primary outcome
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
3 secondary outcomes
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lavanya P Parsons, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosy app in people with Sexual Dysfunction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lavanya P Parsons, MD ((713) 500-6440, Lavanya.H.PalavalliParsons@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) (time frame: Baseline, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.