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| Name | Class |
|---|---|
| Intimate Pathways Center for Sexual Health | UNKNOWN |
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The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are:
Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 16 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMBRACE Group | Experimental | Immediately following consent, participants randomized to the EMBRACE Group will begin with the EMBRACE intervention. Participants will meet with a registered nurse certified in sexuality and sex education for 8 sessions every two weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. By session 2, participants will receive vaginal rehydration (Hyalo-Gyn suppositories), vaginal dilation (CalExotics Dr. Berman Dilator), and vaginal lubrication (Good Clean Love BioNude). These products will be mailed to participants at no cost to the participants. Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150. |
|
| Delayed EMBRACE Group | Active Comparator | After consenting, participants randomized to the Delayed EMBRACE Group will begin with the EMBRACE intervention 16 weeks after enrollment. Participants will meet with a registered nurse certified in sexuality and sex education for 8 sessions every two weeks depending on scheduling. Each of the 8 sessions will last between 60 - 90 minutes. By session 2, participants will receive vaginal rehydration (Hyalo-Gyn suppositories), vaginal dilation (CalExotics Dr. Berman Dilator), and vaginal lubrication (Good Clean Love BioNude). These products will be mailed to participants at no cost to the participants. Participants will complete baseline measures, immediately following the intervention, and six weeks after the last session. Participants will be compensated for their time with a total up to $150. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMBRACE (Empowerment through Mind and Body Reclamation After Cancer Experience) | Behavioral | The intervention will be led by a registered nurse who holds certifications in sexuality counseling and sex education. The therapeutic, online environment will serve as a confidential, private space without judgement to encourage discussion to model safe sexuality communication for breast cancer survivors. The curriculum will include: i) psychoeducation: sexual body, mind-body connection, and sexual relationships; ii) physical-body education: physical response, safety, and navigating physical changes in survivorship; iii) solution-focused tools: tailored vaginal rehydration, lubrication, education; and iv) communication: internal, partnered, and patient-provider communication skills. The solution-focused tools will include vaginal rehydration and dilation products with vaginal lubrication. Tools will be distributed via mail by Session 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Vulvovaginal Symptoms Questionnaire (VSQ) | A 21-item survey designed to measure vaginal symptoms, emotions, life impact due to vulvovaginal symptoms, and sexual impact of vulvovaginal symptoms. The scores range from 0 - 20 with the higher score meaning greater impact from vulvovaginal symptoms. | Week 1, Week 16, Week 22 |
| Body Image Scale | A 10-item survey designed to measure body image changes after cancer treatment. Scores range from 0 - 30 with the higher scores representing more body image disturbances related to cancer treatment. | Week 1, Week 16, Week 22 |
| Female Sexual Functioning Index | A 19-item survey measuring female sexual functioning. Scores range from 2 - 36 with the higher score representing greater sexual function. | Week 1, Week 16, Week 22 |
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Inclusion Criteria:
Exclusion Criteria:
Participant eligibility is based on gender at birth.
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| Name | Affiliation | Role |
|---|---|---|
| Pearman D Parker, PhD, MPH, RN | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23635341 | Background | Juraskova I, Jarvis S, Mok K, Peate M, Meiser B, Cheah BC, Mireskandari S, Friedlander M. The acceptability, feasibility, and efficacy (phase I/II study) of the OVERcome (Olive Oil, Vaginal Exercise, and MoisturizeR) intervention to improve dyspareunia and alleviate sexual problems in women with breast cancer. J Sex Med. 2013 Oct;10(10):2549-58. doi: 10.1111/jsm.12156. Epub 2013 May 1. | |
| 36176069 |
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|
| Background |
| Wettergren L, Eriksson LE, Bergstrom C, Hedman C, Ahlgren J, Smedby KE, Hellman K, Henriksson R, Lampic C. Prevalence and risk factors for sexual dysfunction in young women following a cancer diagnosis - a population-based study. Acta Oncol. 2022 Oct;61(10):1165-1172. doi: 10.1080/0284186X.2022.2112283. Epub 2022 Sep 29. |
| 32968951 | Background | Marsh S, Borges VF, Coons HL, Afghahi A. Sexual health after a breast cancer diagnosis in young women: clinical implications for patients and providers. Breast Cancer Res Treat. 2020 Dec;184(3):655-663. doi: 10.1007/s10549-020-05880-3. Epub 2020 Sep 23. |
| 36795172 | Background | Rash JK, Seaborne LA, Peterson M, Kushner DM, Sobecki JN. Patient reported improvement in sexual health outcomes following care in a sexual health clinic for women with cancer. Support Care Cancer. 2023 Feb 16;31(3):171. doi: 10.1007/s00520-023-07635-4. |
| 29356610 | Background | Esplen MJ, Wong J, Warner E, Toner B. Restoring Body Image After Cancer (ReBIC): Results of a Randomized Controlled Trial. J Clin Oncol. 2018 Mar 10;36(8):749-756. doi: 10.1200/JCO.2017.74.8244. Epub 2018 Jan 22. |
| 34104572 | Background | Mifsud A, Pehlivan MJ, Fam P, O'Grady M, van Steensel A, Elder E, Gilchrist J, Sherman KA. Feasibility and pilot study of a brief self-compassion intervention addressing body image distress in breast cancer survivors. Health Psychol Behav Med. 2021 May 21;9(1):498-526. doi: 10.1080/21642850.2021.1929236. |
| 20885305 | Background | Jun EY, Kim S, Chang SB, Oh K, Kang HS, Kang SS. The effect of a sexual life reframing program on marital intimacy, body image, and sexual function among breast cancer survivors. Cancer Nurs. 2011 Mar-Apr;34(2):142-9. doi: 10.1097/NCC.0b013e3181f1ab7a. |
| 21199377 | Background | Panjari M, Bell RJ, Davis SR. Sexual function after breast cancer. J Sex Med. 2011 Jan;8(1):294-302. doi: 10.1111/j.1743-6109.2010.02034.x. Epub 2010 Sep 23. |
| 31147983 | Background | Rosenberg SM, Vaz-Luis I, Gong J, Rajagopal PS, Ruddy KJ, Tamimi RM, Schapira L, Come S, Borges V, de Moor JS, Partridge AH. Employment trends in young women following a breast cancer diagnosis. Breast Cancer Res Treat. 2019 Aug;177(1):207-214. doi: 10.1007/s10549-019-05293-x. Epub 2019 May 30. |
| 26859752 | Background | Ruddy KJ, Greaney ML, Sprunck-Harrild K, Meyer ME, Emmons KM, Partridge AH. A qualitative exploration of supports and unmet needs of diverse young women with breast cancer. J Community Support Oncol. 2015 Sep;13(9):323-9. doi: 10.12788/jcso.0169. |
| 36431200 | Background | Vegunta S, Kuhle CL, Vencill JA, Lucas PH, Mussallem DM. Sexual Health after a Breast Cancer Diagnosis: Addressing a Forgotten Aspect of Survivorship. J Clin Med. 2022 Nov 14;11(22):6723. doi: 10.3390/jcm11226723. |
| 32703034 | Background | Gorman JR, Drizin JH, Smith E, Flores-Sanchez Y, Harvey SM. Patient-Centered Communication to Address Young Adult Breast Cancer Survivors' Reproductive and Sexual Health Concerns. Health Commun. 2021 Nov;36(13):1743-1758. doi: 10.1080/10410236.2020.1794550. Epub 2020 Jul 23. |
| ID | Term |
|---|---|
| D008594 | Menopause, Premature |
| D012735 | Sexual Dysfunction, Physiological |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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