Evaluation of the Prevalence of Pelvic Static Disorders in Women With Localized Breast Cancer

NCT04515888 | Completed

• 1 other identifier: PROICM 2020-01 OST
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients

Conditions

Breast Cancer

Keywords

localized breast cancer; pelvic static disorders; hormontherapy

Outcome Measures

Primary Outcomes (1)

• Evaluate the prevalence of pelvic static disorders in patients treated for localized breast cancer and undergoing adjuvant hormone therapy (Hormontherapy +).

  Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients (hormonotherapy +)

  Day 1

Secondary Outcomes (6)

• Evaluate the prevalence of pelvic static disorders in patients (hormonotherapy -)

  Day 1

• Compare the prevalence of Pelvic static disorders between the 2 groups Hormonotherapy - /Hormonotherapy +

  Day 1

• Evaluate the impact of pelvic static disorders on quality of life

  Day 1

• Estimate pelvic symptoms in the hormone therapy (Hormonotherapy +) / Non hormone therapy (Hormonotherapy -) groups

  Day 1

• Evaluate the correlation between hormone therapy and pelvic static disorders

  Day 1

Study Arms (2)

target population

The target population of the study consists of breast cancer female patients over 50 years old followed for an invasive carcinoma expressing hormone receptors, non metastatic, undergoing adjuvant hormone therapy.

Other: PFDI-20 / PFIQ-7 questionnaires

control population

The control group will be composed of patients followed for an in situ carcinoma treated by surgery +/- radiotherapy, without hormone therapy.

Other: PFDI-20 / PFIQ-7 questionnaires

Interventions

PFDI-20 / PFIQ-7 questionnaires OTHER

PFDI-20 / PFIQ-7 questionnaires (one shot)

control population; target population

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target population of the study consists of breast cancer female patients over 50 years old followed for an invasive carcinoma expressing hormone receptors, non metastatic, undergoing adjuvant hormone therapy. The control group will be composed of patients followed for an in situ carcinoma treated by surgery +/- radiotherapy, without hormone therapy

You may qualify if:

• Women with Age ≥ 50 years
• Menopaused
• Patient followed for carcinoma in situ or infiltrating the breast with or without hormone therapy
• Patient who was treated by surgery after June 2015, whether or not followed by radiotherapy or chemotherapy.
• Patient who agreed, after receiving information, to participate to the study.

You may not qualify if:

• Metastatic breast cancer
• Patient with a history of pelvic static surgery
• Patient with a history of pelvic irradiation
• Patient unable or unwilling to complete the questionnaires
• Patient with a history of urinary incontinence treatment
• Patient not affiliated to the French social security system
• Subject under tutelage, curatorship or safeguard of justice,
• Patient in an emergency situation,
• Patient whose regular monitoring is impossible for psychological, family, social or geographical reasons,
• Pregnant and / or breastfeeding woman.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Icm Val D'Aurelle

Montpellier, Herault, 34298, France

Location

Related Publications (14)

• Cowppli-Bony A, Colonna M, Ligier K, Jooste V, Defossez G, Monnereau A; le Reseau Francim; Reseau des registres de cancer Francim. [Descriptive epidemiology of cancer in metropolitan France: Incidence, survival and prevalence]. Bull Cancer. 2019 Jul-Aug;106(7-8):617-634. doi: 10.1016/j.bulcan.2018.11.016. Epub 2019 Mar 2. French.

  PMID: 30833045 RESULT

• Jones SE, Cantrell J, Vukelja S, Pippen J, O'Shaughnessy J, Blum JL, Brooks R, Hartung NL, Negron AG, Richards DA, Rivera R, Holmes FA, Chittoor S, Whittaker TL, Bordelon JH, Ketchel SJ, Davis JC, Ilegbodu D, Kochis J, Asmar L. Comparison of menopausal symptoms during the first year of adjuvant therapy with either exemestane or tamoxifen in early breast cancer: report of a Tamoxifen Exemestane Adjuvant Multicenter trial substudy. J Clin Oncol. 2007 Oct 20;25(30):4765-71. doi: 10.1200/JCO.2007.10.8274.

  PMID: 17947724 RESULT

• Kelley C. Estrogen and its effect on vaginal atrophy in post-menopausal women. Urol Nurs. 2007 Feb;27(1):40-5.

  PMID: 17390926 RESULT

• Chin SN, Trinkaus M, Simmons C, Flynn C, Dranitsaris G, Bolivar R, Clemons M. Prevalence and severity of urogenital symptoms in postmenopausal women receiving endocrine therapy for breast cancer. Clin Breast Cancer. 2009 May;9(2):108-17. doi: 10.3816/CBC.2009.n.020.

  PMID: 19433392 RESULT

• Sousa MS, Peate M, Jarvis S, Hickey M, Friedlander M. A clinical guide to the management of genitourinary symptoms in breast cancer survivors on endocrine therapy. Ther Adv Med Oncol. 2017 Apr;9(4):269-285. doi: 10.1177/1758834016687260. Epub 2017 Jan 31.

  PMID: 28491147 RESULT

• Robinson PJ, Bell RJ, Christakis MK, Ivezic SR, Davis SR. Aromatase Inhibitors Are Associated With Low Sexual Desire Causing Distress and Fecal Incontinence in Women: An Observational Study. J Sex Med. 2017 Dec;14(12):1566-1574. doi: 10.1016/j.jsxm.2017.09.018. Epub 2017 Oct 21.

  PMID: 29066307 RESULT

• Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057.

  PMID: 24463674 RESULT

• Islam RM, Oldroyd J, Rana J, Romero L, Karim MN. Prevalence of symptomatic pelvic floor disorders in community-dwelling women in low and middle-income countries: a systematic review and meta-analysis. Int Urogynecol J. 2019 Dec;30(12):2001-2011. doi: 10.1007/s00192-019-03992-z. Epub 2019 Jun 4.

  PMID: 31165221 RESULT

• Weintraub AY, Glinter H, Marcus-Braun N. Narrative review of the epidemiology, diagnosis and pathophysiology of pelvic organ prolapse. Int Braz J Urol. 2020 Jan-Feb;46(1):5-14. doi: 10.1590/S1677-5538.IBJU.2018.0581.

  PMID: 31851453 RESULT

• Ramaseshan AS, Felton J, Roque D, Rao G, Shipper AG, Sanses TVD. Pelvic floor disorders in women with gynecologic malignancies: a systematic review. Int Urogynecol J. 2018 Apr;29(4):459-476. doi: 10.1007/s00192-017-3467-4. Epub 2017 Sep 19.

  PMID: 28929201 RESULT

• Rutledge TL, Heckman SR, Qualls C, Muller CY, Rogers RG. Pelvic floor disorders and sexual function in gynecologic cancer survivors: a cohort study. Am J Obstet Gynecol. 2010 Nov;203(5):514.e1-7. doi: 10.1016/j.ajog.2010.08.004. Epub 2010 Sep 24.

  PMID: 20869691 RESULT

• Neron M, Bastide S, Tayrac R, Masia F, Ferrer C, Labaki M, Boileau L, Letouzey V, Huberlant S. Impact of gynecologic cancer on pelvic floor disorder symptoms and quality of life: an observational study. Sci Rep. 2019 Feb 19;9(1):2250. doi: 10.1038/s41598-019-38759-5.

  PMID: 30783163 RESULT

• Wiegersma M, Panman CM, Berger MY, De Vet HC, Kollen BJ, Dekker JH. Minimal important change in the pelvic floor distress inventory-20 among women opting for conservative prolapse treatment. Am J Obstet Gynecol. 2017 Apr;216(4):397.e1-397.e7. doi: 10.1016/j.ajog.2016.10.010. Epub 2016 Oct 15.

  PMID: 27751796 RESULT

• Fallowfield LJ, Bliss JM, Porter LS, Price MH, Snowdon CF, Jones SE, Coombes RC, Hall E. Quality of life in the intergroup exemestane study: a randomized trial of exemestane versus continued tamoxifen after 2 to 3 years of tamoxifen in postmenopausal women with primary breast cancer. J Clin Oncol. 2006 Feb 20;24(6):910-7. doi: 10.1200/JCO.2005.03.3654.

  PMID: 16484701 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laure DELMOND, MD

  ICM Val d'Aurelle

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 17, 2020
• Study Start: September 18, 2020
• Primary Completion: February 12, 2021
• Study Completion: July 6, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)