Clinical trial NCT06121258: Sexual Health and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment
Official title: Sexual Health and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Sexual Dysfunction
Keywords: Breast cancer
sexual health
educational video
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of the educational video series after six-months of access and use by breast cancer patients as measured by AIM instrument.
timeFrame: 6 months
measure: Appropriateness of the educational video series after six-months of access and use by breast cancer patients as measured by IAM instrument.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in sexual health and function at six-months, as measured by the PROMIS Sexual Function v2 Brief Profile (Female)
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Health
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sarah E Tevis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.