NCT03153631

Brief Summary

Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death among females world wide. breast cancer alone accounts for 25% of all cancer cases and 15% of all cancer deaths among females.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Status
unknown

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

May 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 12, 2017

Last Update Submit

May 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment of female sexual dysfunction in breast cancer patients after mastectomy using questionaire

    description of manner of female sexual dysfunction after mastectomy using Arabic Female Sexual Function Index and FEMALE SEXUAL FUNCTION INDEX DOMAIN SCORES AND FULL SCALE SCORE

    one month

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Seventy five female, with cancer breast who did mastectomy at child bearing period, will be recruited from the outpatient clinic of clinical oncology department in Assiut University hospital and South Egypt Cancer Institute.

You may qualify if:

  • Age: 18-40 years old.
  • Social status: Married.
  • (Performance status): Who 0-1
  • Asymptomatic (fully active, able to carry on all predisease activities without restriction)
  • Symptomatic but completely ambulatory (restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature. For example, light housework, office work)

You may not qualify if:

  • Pregnant women.
  • Comorbidities (Diabetes mellitus., Hypertension).
  • Female genital tract disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Bober SL, Varela VS. Sexuality in adult cancer survivors: challenges and intervention. J Clin Oncol. 2012 Oct 20;30(30):3712-9. doi: 10.1200/JCO.2012.41.7915. Epub 2012 Sep 24.

    PMID: 23008322BACKGROUND
  • Chapman RM. Effect of cytotoxic therapy on sexuality and gonadal function. Semin Oncol. 1982 Mar;9(1):84-94.

    PMID: 6176028BACKGROUND
  • Derogatis LR, Morrow GR, Fetting J, Penman D, Piasetsky S, Schmale AM, Henrichs M, Carnicke CL Jr. The prevalence of psychiatric disorders among cancer patients. JAMA. 1983 Feb 11;249(6):751-7. doi: 10.1001/jama.249.6.751.

    PMID: 6823028BACKGROUND
  • Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

    PMID: 25220842BACKGROUND
  • Katz RC, Jardine D. The relationship between worry, sexual aversion, and low sexual desire. J Sex Marital Ther. 1999 Oct-Dec;25(4):293-6. doi: 10.1080/00926239908404006.

    PMID: 10546167BACKGROUND
  • Fobair P, Stewart SL, Chang S, D'Onofrio C, Banks PJ, Bloom JR. Body image and sexual problems in young women with breast cancer. Psychooncology. 2006 Jul;15(7):579-94. doi: 10.1002/pon.991.

    PMID: 16287197BACKGROUND
  • Sadovsky R, Basson R, Krychman M, Morales AM, Schover L, Wang R, Incrocci L. Cancer and sexual problems. J Sex Med. 2010 Jan;7(1 Pt 2):349-73. doi: 10.1111/j.1743-6109.2009.01620.x.

    PMID: 20092444BACKGROUND

Central Study Contacts

Dalia Abd El-Aziz Ahmed, MD

CONTACT

HANAN Ahmed Morsy, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
princilal investigator

Study Record Dates

First Submitted

May 12, 2017

First Posted

May 15, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

May 16, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share