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Sexual Health in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05138510
Recruitment Status : Recruiting
First Posted : December 1, 2021
Last Update Posted : December 14, 2022
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: Focus Group

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:

  1. 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.

  2. 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
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sexuality and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Stage 0
Ductal carcinoma in situ. Timing: start of endocrine therapy
 Behavioral: Focus Group

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.
Stages I-III Surgery first
Invasive cancer. Surgery first Timing: start of endocrine therapy
 Behavioral: Focus Group

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.
Stages I-III, neoadjuvant chemotherapy first
Invasive cancer. Neoadjuvant chemotherapy first Timing: during neoadjuvant chemotherapy
 Behavioral: Focus Group

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.
Stage IV
Metastatic cancer, chemotherapy only, no invasive surgery Timing: 2 months into treatment
 Behavioral: Focus Group

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.
Survivors
Timing: any time
 Behavioral: Focus Group

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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients less than 18 years of age and those with non-cancer diagnoses or prior history of breast cancer will be excluded.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05138510


Contacts
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Contact: Victoria Huynh 8327202162 victoria.d.huynh@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Victoria Huynh, MD         
Contact    8327202162      
Sub-Investigator: Anosheh Afghahi         
Sub-Investigator: Victoria Huynh         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Sarah Tevis Colorado Research Center
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT05138510    
Other Study ID Numbers: 20-1789.cc
First Posted: December 1, 2021    Key Record Dates
Last Update Posted: December 14, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases