Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study

NCT06458764 | Recruiting

• 1 other identifier: 71/2023
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objectives:

• To estimate Sexual Dysfunction (SD) incidence in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.
• To detect the presence of SD-related distress in the population, as a determining factor in the maintenance of a good quality of life. Secondary objectives:
• To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens.
• Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.

Conditions

Breast Cancer Female; Sexual Dysfunction; Premenopausal Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Sexual Dysfunction (SD) incidence

  To estimate Sexual Dysfunction (SD) incidence (physiological parameter) in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.

  6 months

• SD-related distress

  To detect the presence of SD-related distress (physiological parameter) in the population, as a determining factor in the maintenance of a good quality of life.

  6 months

Secondary Outcomes (2)

• SD characteristics

  6 months

• Collect baseline data

  6 months

Study Arms (2)

Patients

Other: Questionnaire

Controls

Other: Questionnaire

Interventions

Questionnaire OTHER

none, it's a incidence-prevalence study

Controls; Patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged ≥18 and ≤ 55 who underwent surgery for early stage breast cancer, taking endocrine therapy for at least 3 months

You may qualify if:

• women aged ≥18 and ≤ 55
• who underwent surgery for early stage breast cancer
• taking endocrine therapy for at least 3 months
• providing an informed consent and completing the study questionnaires.

You may not qualify if:

• withdrawal of the informed consent, at any time

Sponsors & Collaborators

• Candiolo Cancer Institute - IRCCS: lead

Study Sites (1)

IRCCS Candiolo Cancer Center

Torino, TO, 10060, Italy

RECRUITING

Related Publications (16)

• McCool ME, Zuelke A, Theurich MA, Knuettel H, Ricci C, Apfelbacher C. Prevalence of Female Sexual Dysfunction Among Premenopausal Women: A Systematic Review and Meta-Analysis of Observational Studies. Sex Med Rev. 2016 Jul;4(3):197-212. doi: 10.1016/j.sxmr.2016.03.002. Epub 2016 Apr 19.

  PMID: 27871953 BACKGROUND

• Jing L, Zhang C, Li W, Jin F, Wang A. Incidence and severity of sexual dysfunction among women with breast cancer: a meta-analysis based on female sexual function index. Support Care Cancer. 2019 Apr;27(4):1171-1180. doi: 10.1007/s00520-019-04667-7. Epub 2019 Feb 2.

  PMID: 30712099 BACKGROUND

• Seav SM, Dominick SA, Stepanyuk B, Gorman JR, Chingos DT, Ehren JL, Krychman ML, Su HI. Management of sexual dysfunction in breast cancer survivors: a systematic review. Womens Midlife Health. 2015 Nov 2;1:9. doi: 10.1186/s40695-015-0009-4. eCollection 2015.

  PMID: 30766696 BACKGROUND

• Du H, Chen C, Yuan F, Hu A, Han J. Correlation analysis of body image level and female sexual dysfunction in young patients with postoperative breast cancer. J Cancer Res Ther. 2022 Sep;18(5):1360-1371. doi: 10.4103/jcrt.jcrt_629_21.

  PMID: 36204884 BACKGROUND

• Carmen A, Anne O, Monika S, Daniel E, Johannes G, Verena M, Michael H, Christine B. Does the toxicity of endocrine therapy persist into long-term survivorship?: Patient-reported outcome results from a follow-up study beyond a 10-year-survival. Breast Cancer Res Treat. 2023 Apr;198(3):475-485. doi: 10.1007/s10549-022-06808-9. Epub 2022 Nov 23.

  PMID: 36418518 BACKGROUND

• Sousa Rodrigues Guedes T, Barbosa Otoni Goncalves Guedes M, de Castro Santana R, Costa da Silva JF, Almeida Gomes Dantas A, Ochandorena-Acha M, Terradas-Monllor M, Jerez-Roig J, Bezerra de Souza DL. Sexual Dysfunction in Women with Cancer: A Systematic Review of Longitudinal Studies. Int J Environ Res Public Health. 2022 Sep 21;19(19):11921. doi: 10.3390/ijerph191911921.

  PMID: 36231221 BACKGROUND

• Qi A, Li Y, Sun H, Jiao H, Liu Y, Chen Y. Incidence and risk factors of sexual dysfunction in young breast cancer survivors. Ann Palliat Med. 2021 Apr;10(4):4428-4434. doi: 10.21037/apm-21-352.

  PMID: 33966393 BACKGROUND

• Taylor CE, Meisel JL. Management of Breast Cancer Therapy-Related Sexual Dysfunction. Oncology (Williston Park). 2017 Oct 15;31(10):726-9.

  PMID: 29083465 BACKGROUND

• Gorman JR, Lyons KS, Harvey SM, Acquati C, Salsman JM, Kashy DA, Drizin JH, Smith E, Flexner LM, Hayes-Lattin B, Reese JB. Opening the Conversation: study protocol for a Phase III trial to evaluate a couple-based intervention to reduce reproductive and sexual distress among young adult breast and gynecologic cancer survivor couples. Trials. 2022 Sep 2;23(1):730. doi: 10.1186/s13063-022-06665-3.

  PMID: 36056413 BACKGROUND

• Advani P, Brewster AM, Baum GP, Schover LR. A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy. J Cancer Surviv. 2017 Aug;11(4):477-485. doi: 10.1007/s11764-017-0606-3. Epub 2017 Feb 22.

  PMID: 28229275 BACKGROUND

• Ljungman L, Ahlgren J, Petersson LM, Flynn KE, Weinfurt K, Gorman JR, Wettergren L, Lampic C. Sexual dysfunction and reproductive concerns in young women with breast cancer: Type, prevalence, and predictors of problems. Psychooncology. 2018 Dec;27(12):2770-2777. doi: 10.1002/pon.4886. Epub 2018 Sep 27.

  PMID: 30203884 BACKGROUND

• Maiorino MI, Chiodini P, Bellastella G, Giugliano D, Esposito K. Sexual dysfunction in women with cancer: a systematic review with meta-analysis of studies using the Female Sexual Function Index. Endocrine. 2016 Nov;54(2):329-341. doi: 10.1007/s12020-015-0812-6. Epub 2015 Dec 7.

  PMID: 26643312 BACKGROUND

• Fogh M, Hojgaard A, Rotbol CB, Jensen AB. The majority of Danish breast cancer survivors on adjuvant endocrine therapy have clinically relevant sexual dysfunction: a cross-sectional study. Acta Oncol. 2021 Jan;60(1):61-68. doi: 10.1080/0284186X.2020.1813326. Epub 2020 Sep 1.

  PMID: 32869712 BACKGROUND

• Gandhi C, Butler E, Pesek S, Kwait R, Edmonson D, Raker C, Clark MA, Stuckey A, Gass J. Sexual Dysfunction in Breast Cancer Survivors: Is it Surgical Modality or Adjuvant Therapy? Am J Clin Oncol. 2019 Jun;42(6):500-506. doi: 10.1097/COC.0000000000000552.

  PMID: 31094713 BACKGROUND

• Cobo-Cuenca AI, Martin-Espinosa NM, Sampietro-Crespo A, Rodriguez-Borrego MA, Carmona-Torres JM. Sexual dysfunction in Spanish women with breast cancer. PLoS One. 2018 Aug 31;13(8):e0203151. doi: 10.1371/journal.pone.0203151. eCollection 2018.

  PMID: 30169506 BACKGROUND

• Carpenter JS, Reed SD, Guthrie KA, Larson JC, Newton KM, Lau RJ, Learman LA, Shifren JL. Using an FSDS-R Item to Screen for Sexually Related Distress: A MsFLASH Analysis. Sex Med. 2015 Mar;3(1):7-13. doi: 10.1002/sm2.53.

  PMID: 25844170 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 14, 2024
• Study Start: May 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 24, 2025

Record last verified: 2024-06

Locations

IT (1)