NCT07644858

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

focus groupsexual healthintimacyquality of lifesupport

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    3 months

Secondary Outcomes (2)

  • Develop a Grounded Theory Framework for a Pilot Survey Instrument

    1 year

  • Identify Key Themes and Topics for Conversational AI Design

    1 year

Interventions

The study involves focus group discussions conducted via Zoom and online questionnaires administered to breast cancer patients and survivors.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFloridian women diagnosed with breast cancer (active patient and survivors)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • prisoners
  • unable to understand English and provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32827, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and QuestionnairesFocus Groups

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 12, 2026

Study Start

March 12, 2026

Primary Completion

June 5, 2026

Study Completion

June 5, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Locations