Breast CancerNCT07644858
MammoVerse: Breast Cancer Sexual Health Focus Groups
An observational study of Breast Cancer, run by University of Central Florida at 1 site in United States.
Trial summary
The purpose of this study is to explore the lived experiences, emotional challenges, and coping processes related to changes in sexual health and intimacy among women diagnosed with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Questionnaires and Focus Group
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2026to 5 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Floridian women who have been diagnosed with breast cancer can enroll in the study online. Screening: Participants who provide informed consent will then be selfscreened through a brief eligibility questionnaire that is self-administered online. Based on the answers to the eligibility questions below, participants may be self-screened out of the study.
Who may be able to join
- female
- diagnosed with breast cancer (current patients and survivors);
- can provide informed consent;
- are self-reporting that they are emotionally (based on clinical questionnaires below) and
- are self-reporting that they are physically able to participate in a 60-minute group discussion.
Who cannot join
- prisoners
- unable to understand English and provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32827
About this study
Official title: MammoVerse: Exploring Sexual Health and Intimacy Experiences Among Women Diagnosed With Breast Cancer
The purpose of this study is to explore the lived experiences, emotional challenges, and coping processes related to changes in sexual health and intimacy among women diagnosed with breast cancer. Insights gained from participants' personal experiences will provide a deeper understanding of patients' informational, emotional, and relational support needs, which will inform the development of an AI-driven digital support platform aimed at delivering personalized education, facilitating communication, and improving overall quality of life among women living with and beyond breast cancer in Florida.
The study involves focus group discussions conducted via Zoom and online questionnaires administered to breast cancer patients and survivors.
- Conditions
- Breast Cancer
- Being tested
- Questionnaires and Focus Group
- Keywords
- focus group, sexual health, intimacy, quality of life, support
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and Focus GroupOther
The study involves focus group discussions conducted via Zoom and online questionnaires administered to breast cancer patients and survivors.
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Foundation for Understanding Sexual Health and Intimacy Experiences of Women Diagnosed with Breast Cancer during Focus Group Discussion.
To explore how women with breast cancer experience, interpret, and cope with changes in sexual health, intimacy, body image, and partner relationships, and to extract themes that capture shared patterns in lived experiences across participants. This qualitative exploration will employ grounded theory methods to understand intimacy related changes and coping processes in the context of cancer diagnosis and treatment.
Measured: 3 months
Sexual functioning assessment using Female Sexual Function Index (FSFI)
A validated multidimensional questionnaire assessing sexual desire, arousal, lubrication, orgasm, satisfaction, and pain, and is widely used in breast cancer survivorship research to evaluate sexual functioning
Measured: 3 Months
Sexual Distress Assessment using Female Sexual Distress Scale Revised (FSDS R)
A validated screening instrument measuring sexually related personal distress, which helps determine the emotional burden associated with sexual dysfunction.
Measured: 3 months
Secondary outcomes (2)
Develop a Grounded Theory Framework for a Pilot Survey Instrument
Using grounded theory analysis, emergent qualitative themes will be translated into measurable constructs to inform the design of a lived experience-based pilot survey instrument assessing sexual health and intimacy concerns following breast cancer. This instrument will later be refined and validated in a subsequent quantitative study to evaluate sexual well-being and coping patterns in larger breast cancer populations, supporting theory development and instrument construction through iterative qualitative to quantitative integration.
Measured: 1 year
Identify Key Themes and Topics for Conversational AI Design
To identify language patterns, discussion topics, and interaction themes that can inform supportive care capable of responding empathetically and contextually to sexual health, intimacy, and relationship concerns associated with breast cancer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start12 Mar 2026
- Primary completion5 Jun 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644858
- Sponsor's protocol ID
- STUDY00008954
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MammoVerse: Exploring Sexual Health and Intimacy Experiences Among Women Diagnosed With Breast Cancer
- ClinicalTrials.gov ID
- NCT07644858
- Acronym / sponsor ID
- STUDY00008954
- Conditions
- Breast Cancer
- Keywords
- focus group, sexual health, intimacy, quality of life, support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 12 Jun 2026 (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 explore the lived experiences, emotional challenges, and coping processes related to changes in sexual health and intimacy among women diagnosed with breast cancer. Insights gained from participants' personal experiences will provide a deeper understanding of patients' informational, emotional, and relational support needs, which will inform the development of an AI-driven digital support platform aimed at delivering personalized education, facilitating communication, and improving overall quality of life among women living with and beyond breast cancer in Florida.
The study involves focus group discussions conducted via Zoom and online questionnaires administered to breast cancer patients and survivors.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Floridian women who have been diagnosed with breast cancer can enroll in the study online. Screening: Participants who provide informed consent will then be selfscreened through a brief eligibility questionnaire that is self-administered online. Based on the answers to the eligibility questions below, participants may be self-screened out of the study.
Key inclusion criteria (5 listed)
- female
- diagnosed with breast cancer (current patients and survivors);
- can provide informed consent;
- are self-reporting that they are emotionally (based on clinical questionnaires below) and
- are self-reporting that they are physically able to participate in a 60-minute group discussion.
Key exclusion criteria (2 listed)
- prisoners
- unable to understand English and provide consent
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 |
|---|---|---|
| Questionnaires and Focus GroupThe study involves focus group discussions conducted via Zoom and online questionnaires administered to breast cancer patients and survivors. | Other | – |
Primary outcome
Qualitative Foundation for Understanding Sexual Health and Intimacy Experiences of Women Diagnosed with Breast Cancer during Focus Group Discussion.
Time frame: 3 months
To explore how women with breast cancer experience, interpret, and cope with changes in sexual health, intimacy, body image, and partner relationships, and to extract themes that capture shared patterns in lived experiences across participants. This qualitative exploration will employ grounded theory methods to understand intimacy related changes and coping processes in the context of cancer diagnosis and treatment.
Sexual functioning assessment using Female Sexual Function Index (FSFI)
Time frame: 3 Months
A validated multidimensional questionnaire assessing sexual desire, arousal, lubrication, orgasm, satisfaction, and pain, and is widely used in breast cancer survivorship research to evaluate sexual functioning
Sexual Distress Assessment using Female Sexual Distress Scale Revised (FSDS R)
Time frame: 3 months
A validated screening instrument measuring sexually related personal distress, which helps determine the emotional burden associated with sexual dysfunction.
2 secondary outcomes
Develop a Grounded Theory Framework for a Pilot Survey Instrument
Time frame: 1 year
Identify Key Themes and Topics for Conversational AI Design
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Central Florida 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 5 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: finished, as of the sponsor's last update on 12 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Foundation for Understanding Sexual Health and Intimacy Experiences of Women Diagnosed with Breast Cancer during Focus Group Discussion. (time frame: 3 months). The study lists 3 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 12 Jun 2026.