Breast CancerNCT05138510
Sexual Health in Breast Cancer Patients
An observational study of Breast Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
In the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment. 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?
- Focus Group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 23 Oct 2025
- 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: All patients diagnosed with ductal carcinoma in situ or invasive breast cancer, seen in the breast center between 9/1/2019 to present, will potentially be recruited to participate. Patients less than 18 years of age and those with non-cancer diagnoses or prior history of breast cancer will be excluded.
Who may be able to join
- Patients diagnosed with ductal carcinoma in situ or invasive breast cancer, seen in the breast center between 09/01/2019 to present, will potentially be recruited to participate.
Who cannot join
- Patients less than 18 years of age and those with non-cancer diagnoses or prior history of breast cancer will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Sexuality and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment
In the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment.
Read the detailed description
In the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment. The objectives are as follows:
- To characterize the sexual well-being of women longitudinally throughout the continuum of care, from initial diagnosis into survivorship. We predict that treatment will adversely affect sexual well-being, and that patient factors, clinical factors, and treatment choices will influence changes in sexual well-being.
- To identify gaps is sexual health education provided at the time of diagnosis or during treatment and to determine the appropriate timing of sexual health education delivery.
- Conditions
- Breast Cancer
- Being tested
- Focus Group
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupBehavioural
Providers with extensive training and expertise in the subject will lead the virtual focus groups over Zoom using a semi-structured guide. Topics will focus on education received from the health care team, information received from outside sources, and patient recommendations on the type and timing of information preferred.
We will create an analytic report based on the focus group findings, which will be used to inform the development of educational material.
Sexual well-being is currently measured longitudinally on a 0-100 point scale as a component of a validated patient-reported outcome measures (PROM) survey (BREAST-Q) distributed to all breast cancer patients. These scores will be analyzed in patients with and without educational interventions for comparison.
| Study group | Role | What they receive |
|---|---|---|
| Stage 0 | Ductal carcinoma in situ. Timing: start of endocrine therapy Receives: Behavioral: Focus Group | |
| Stages I-III Surgery first | Invasive cancer. Surgery first Timing: start of endocrine therapy Receives: Behavioral: Focus Group | |
| Stages I-III, neoadjuvant chemotherapy first | Invasive cancer. Neoadjuvant chemotherapy first Timing: during neoadjuvant chemotherapy Receives: Behavioral: Focus Group | |
| Stage IV | Metastatic cancer, chemotherapy only, no invasive surgery Timing: 2 months into treatment Receives: Behavioral: Focus Group | |
| Survivors | Timing: any time Receives: Behavioral: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine changes in sexual well-being for women with breast cancer
Determine changes in sexual well-being throughout the course of breast cancer treatment, pre- and post-implementation of developed educational materials using the Sexual Health Among Women Receiving Breast Cancer Treatment Survey
Measured: 1 year
Determine educational resources currently used for sexual health information
Determine patients' self reported list of educational media received regarding sexual health during breast cancer treatment using the PROM survey (BREAST-Q)
Measured: 1 year
Determine educational resources currently used for sexual health information
Determine patients' self reported list of educational media received regarding sexual health during breast cancer treatment using the Sexual Health Among Women Receiving Breast Cancer Treatment Survey
Measured: 1 year
Determine patients preferred type of education for sexual health
Determine the patients preferred type and timing of educational interventions for sexual health using the Sexual Health Among Women Receiving Breast Cancer Treatment Survey
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 posted1 Dec 2021
- Study start1 Dec 2020
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
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.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Tevis, Principal investigator, Colorado Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138510
- Sponsor's protocol ID
- 20-1789.cc
- Other IDs
- NCI-2021-10894
- Status last verified
- Jan 2026
- First submitted
- 26 Oct 2021
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared with other researchers. Individual Participant Data will be housed in a deidentified format in the secure, encrypted REDCap database of the University of Colorado School od Medicine.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexuality and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment
- ClinicalTrials.gov ID
- NCT05138510
- Acronym / sponsor ID
- 20-1789.cc
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 1 Dec 2021 (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.
In the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment.
Detailed description
In the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment. The objectives are as follows:
- To characterize the sexual well-being of women longitudinally throughout the continuum of care, from initial diagnosis into survivorship. We predict that treatment will adversely affect sexual well-being, and that patient factors, clinical factors, and treatment choices will influence changes in sexual well-being.
- To identify gaps is sexual health education provided at the time of diagnosis or during treatment and to determine the appropriate timing of sexual health education delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stage 0 | – | Behavioral: Focus GroupDuctal carcinoma in situ. Timing: start of endocrine therapy |
| Stages I-III Surgery first | – | Behavioral: Focus GroupInvasive cancer. Surgery first Timing: start of endocrine therapy |
| Stages I-III, neoadjuvant chemotherapy first | – | Behavioral: Focus GroupInvasive cancer. Neoadjuvant chemotherapy first Timing: during neoadjuvant chemotherapy |
| Stage IV | – | Behavioral: Focus GroupMetastatic cancer, chemotherapy only, no invasive surgery Timing: 2 months into treatment |
| Survivors | – | Behavioral: Focus GroupTiming: any time |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with ductal carcinoma in situ or invasive breast cancer, seen in the breast center between 9/1/2019 to present, will potentially be recruited to participate. Patients less than 18 years of age and those with non-cancer diagnoses or prior history of breast cancer will be excluded.
Key inclusion criteria (1 listed)
- Patients diagnosed with ductal carcinoma in situ or invasive breast cancer, seen in the breast center between 09/01/2019 to present, will potentially be recruited to participate.
Key exclusion criteria (1 listed)
- Patients less than 18 years of age and those with non-cancer diagnoses or prior history of breast cancer will be excluded.
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 |
|---|---|---|
| Focus GroupProviders with extensive training and expertise in the subject will lead the virtual focus groups over Zoom using a semi-structured guide. Topics will focus on education received from the health care team, information received from outside sources, and patient recommendations on the type and timing of information preferred. We will create an analytic report based on the focus group findings, which will be used to inform the development of educational material. Sexual well-being is currently measured longitudinally on a 0-100 point scale as a component of a validated patient-reported outcome measures (PROM) survey (BREAST-Q) distributed to all breast cancer patients. These scores will be analyzed in patients with and without educational interventions for comparison. | Behavioural | Stage 0, Stage IV, Stages I-III Surgery first, Stages I-III, neoadjuvant chemotherapy first, Survivors |
Primary outcome
Determine changes in sexual well-being for women with breast cancer
Time frame: 1 year
Determine changes in sexual well-being throughout the course of breast cancer treatment, pre- and post-implementation of developed educational materials using the Sexual Health Among Women Receiving Breast Cancer Treatment Survey
Determine educational resources currently used for sexual health information
Time frame: 1 year
Determine patients' self reported list of educational media received regarding sexual health during breast cancer treatment using the PROM survey (BREAST-Q)
Determine educational resources currently used for sexual health information
Time frame: 1 year
Determine patients' self reported list of educational media received regarding sexual health during breast cancer treatment using the Sexual Health Among Women Receiving Breast Cancer Treatment Survey
Determine patients preferred type of education for sexual health
Time frame: 1 year
Determine the patients preferred type and timing of educational interventions for sexual health using the Sexual Health Among Women Receiving Breast Cancer Treatment Survey
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 28 Jan 2026.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared with other researchers. Individual Participant Data will be housed in a deidentified format in the secure, encrypted REDCap database of the University of Colorado School od Medicine.
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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.
Sarah Tevis principal investigator
Colorado Research Center
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 Colorado, Denver 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 1 inclusion and 1 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 28 Jan 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?
Determine changes in sexual well-being for women with breast cancer (time frame: 1 year). The study lists 4 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 28 Jan 2026.