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OpenTrials
Completed

NCT Number: NCT07644858

MammoVerse: Breast Cancer Sexual Health Focus Groups

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Central Florida

Orlando, Florida, 32827, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • prisoners
  • unable to understand English and provide consent

Treatment and study plan

Questionnaires and Focus Group

Other

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. Develop a Grounded Theory Framework for a Pilot Survey Instrument

    Time frame: 1 year

    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.

  2. Identify Key Themes and Topics for Conversational AI Design

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Registry information

Official study title

MammoVerse: Exploring Sexual Health and Intimacy Experiences Among Women Diagnosed With Breast Cancer

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

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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