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CompletedNCT06121258Updated Feb 27, 2026

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

An interventional study of Educational video series in Breast Cancer Female and Sexual Dysfunction, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Breast Cancer Female
  • Sexual Dysfunction

Keywords

  • Breast cancer
  • sexual health
  • educational video
03

In context

Sexual Dysfunction, Physiological

115 studies on the registry are indexed under Sexual Dysfunction, Physiological; 46 are open to participants now.

This study's enrollment of 32 is below the median of 60 across 80 interventional studies indexed under Sexual Dysfunction, Physiological.

Browse Sexual Dysfunction, Physiological studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Video website access

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

    Other: Educational video series

Interventions

  • OtherEducational 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.

06

What researchers measure

Primary outcomes

  1. Acceptability of the educational video series after six-months of access and use by breast cancer patients as measured by AIM instrument.

    The Acceptability of Intervention Measure (AIM) is a validated instrument used to measure the acceptability of an intervention. Scores range from 0-5. There is no score cut off, however higher scores indicate better outcomes (greater acceptability).

    Time frame: 6 months

  2. Appropriateness of the educational video series after six-months of access and use by breast cancer patients as measured by IAM instrument.

    The Intervention Appropriateness Measure (IAM) is a validated instrument used to measure the appropriateness of an intervention. Scores range from 0-5. There is no score cut off, however higher scores indicate better outcomes (greater appropriateness).

    Time frame: 6 months

  3. Determine the sustainability of the educational video series after six-months of access and use by breast cancer patients as measured by the FIM instrument.

    The Feasibility of Intervention Measure (FIM) is a validated instrument used to measure the feasibility, or sustainability, of an intervention. Scores range from 0-5. There is no score cut off, however higher scores indicate better outcomes (greater feasibility).

    Time frame: 6 months

Secondary outcomes

  1. Change from baseline in sexual health and function at six-months, as measured by the PROMIS Sexual Function v2 Brief Profile (Female)

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function v2 Brief Profile (Female) is a well-validated tool in oncology patients to assess sexual health. Calibrated subdomain scores are expressed as T-scores (mean=50, standard deviation=10). A T-score 50 corresponds to the mean response among cancer survivors used for previous item testing. Higher scores indicate better outcomes within the domain. We will assess the change at 6 months from baseline.

    Time frame: Baseline, 6 months

07

Study locations

1 site
  • University of Colorado Health
    Aurora, Colorado 80045, United States
08

References and documents

Publications

  • 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. PubMed 27492424 ↗
  • 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. PubMed 25534170 ↗
  • 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. PubMed 12618871 ↗
  • 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. PubMed 28547655 ↗
  • 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. PubMed 35915298 ↗
  • 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. PubMed 28851459 ↗
  • 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. PubMed 23387911 ↗
  • Higgins MG, Helmkamp L, Zimmaro LA, Leslie SE, Adams M, Vemuru S, Huynh VD, Baurle E, Bozzuto L, Rojas KE, Coons HL, Arkema A, Tevis S. Preliminary evaluation of the acceptability, appropriateness, and feasibility of an online sexual health educational video series for breast cancer patients. Support Care Cancer. 2026 Jan 26;34(2):130. doi: 10.1007/s00520-026-10381-y. PubMed 41586882 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06121258
Lead sponsor
University of Colorado, Denver
Collaborators
International Society for the Study of Women's Sexual Health
Responsible party
Sponsor
First posted
Nov 7, 2023
Start date
Jan 2, 2024
Primary completion
Jan 22, 2025
Completion
Jan 22, 2025
Last update
Feb 27, 2026

Study contacts

Sarah E Tevis, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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