Sexual Health and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment

NCT ID: NCT06121258

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2026-01-22

Brief Summary

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The purpose of this study is to assess the acceptability, appropriateness, and feasibility of a educational video series for patients going through breast cancer treatment.

Detailed Description

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This is a prospective, mixed methods pilot study to evaluate the acceptability, appropriateness, and feasibility of a novel educational video series for patients going through breast cancer treatment. The video series addresses topics such as what to expect from breast surgery, how to prepare for breast surgery, treatment effects of breast cancer therapies, and mitigation and communication strategies for navigating breast cancer treatment.

Conditions

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Breast Cancer Female Sexual Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Video website access

Participants will gain access to the educational video website in order to watch the series.

Group Type EXPERIMENTAL

Educational video series

Intervention Type OTHER

The intervention is a web-based educational video series that was developed using a patient-centered approach that discusses breast cancer treatment, sexual health side effects, and provides treatment and mitigation strategies for these side effects.

Interventions

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Educational video series

The intervention is a web-based educational video series that was developed using a patient-centered approach that discusses breast cancer treatment, sexual health side effects, and provides treatment and mitigation strategies for these side effects.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Stage I-III invasive breast cancer within one month of initial multi-disciplinary clinic visit or surgical consultation
* Ability to complete survey material independently
* Able to read and speak English
* Willingness to comply with study material and procedures

Exclusion Criteria

* Age \< 18 years old
* Stage 0 or IV breast cancer
* Non-breast cancer diagnoses
* History of anti-hormonal therapy, chemotherapy, or radiotherapy not related to breast cancer
* Prior breast cancer diagnosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah E Tevis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Health

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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Tat S, Doan T, Yoo GJ, Levine EG. Qualitative Exploration of Sexual Health Among Diverse Breast Cancer Survivors. J Cancer Educ. 2018 Apr;33(2):477-484. doi: 10.1007/s13187-016-1090-6.

Reference Type BACKGROUND
PMID: 27492424 (View on PubMed)

Sporn NJ, Smith KB, Pirl WF, Lennes IT, Hyland KA, Park ER. Sexual health communication between cancer survivors and providers: how frequently does it occur and which providers are preferred? Psychooncology. 2015 Sep;24(9):1167-73. doi: 10.1002/pon.3736. Epub 2014 Dec 22.

Reference Type BACKGROUND
PMID: 25534170 (View on PubMed)

Stead ML, Brown JM, Fallowfield L, Selby P. Lack of communication between healthcare professionals and women with ovarian cancer about sexual issues. Br J Cancer. 2003 Mar 10;88(5):666-71. doi: 10.1038/sj.bjc.6600799.

Reference Type BACKGROUND
PMID: 12618871 (View on PubMed)

Stabile C, Goldfarb S, Baser RE, Goldfrank DJ, Abu-Rustum NR, Barakat RR, Dickler MN, Carter J. Sexual health needs and educational intervention preferences for women with cancer. Breast Cancer Res Treat. 2017 Aug;165(1):77-84. doi: 10.1007/s10549-017-4305-6. Epub 2017 May 25.

Reference Type BACKGROUND
PMID: 28547655 (View on PubMed)

Huynh V, Vemuru S, Hampanda K, Pettigrew J, Fasano M, Coons HL, Rojas KE, Afghahi A, Ahrendt G, Kim S, Matlock DD, Tevis SE. No One-Size-Fits-All: Sexual Health Education Preferences in Patients with Breast Cancer. Ann Surg Oncol. 2022 Oct;29(10):6238-6251. doi: 10.1245/s10434-022-12126-7. Epub 2022 Aug 1.

Reference Type BACKGROUND
PMID: 35915298 (View on PubMed)

Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

Reference Type BACKGROUND
PMID: 28851459 (View on PubMed)

Flynn KE, Lin L, Cyranowski JM, Reeve BB, Reese JB, Jeffery DD, Smith AW, Porter LS, Dombeck CB, Bruner DW, Keefe FJ, Weinfurt KP. Development of the NIH PROMIS (R) Sexual Function and Satisfaction measures in patients with cancer. J Sex Med. 2013 Feb;10 Suppl 1(0 1):43-52. doi: 10.1111/j.1743-6109.2012.02995.x.

Reference Type BACKGROUND
PMID: 23387911 (View on PubMed)

Other Identifiers

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23-1734.cc

Identifier Type: -

Identifier Source: org_study_id

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