NCT06121258

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2025

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

October 27, 2023

Last Update Submit

February 24, 2026

Conditions

Breast Cancer FemaleSexual Dysfunction

Keywords

Breast cancersexual healtheducational video

Outcome Measures

Primary Outcomes (3)

  • 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).

    6 months

  • 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).

    6 months

  • 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).

    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)

    Baseline, 6 months

Study Arms (1)

Video website access

EXPERIMENTAL

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

Other: Educational video series

Interventions

Educational video seriesOTHER

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.

Video website access

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Health

Aurora, Colorado, 80045, United States

Location

Related Publications (8)

  • 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.

    PMID: 27492424BACKGROUND

  • 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.

    PMID: 25534170BACKGROUND

  • 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.

    PMID: 12618871BACKGROUND

  • 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.

    PMID: 28547655BACKGROUND

  • 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.

    PMID: 35915298BACKGROUND

  • 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.

    PMID: 28851459BACKGROUND

  • 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.

    PMID: 23387911BACKGROUND

  • 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.

    PMID: 41586882DERIVED

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalBreast Neoplasms

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sarah E Tevis, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 7, 2023

Study Start

January 2, 2024

Primary Completion

January 22, 2025

Study Completion

January 22, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

US(1)