NCT04872803

Brief Summary

Breast cancer is the most common cause of cancer death among women worldwide. Incidence rates are high in more developed countries than rates in less developed countries In Egypt, standardized age of cancers are 166.6per 100.000 in both sexes cancer breast represent 32%in females and 15.4%in both sexes of all cancer Mastectomy is an important treatment method in Brest cancer. But, mastectomy has a deep and stable negative impact on a woman because, mastectomy as a treatment option, can result in a sense of mutilation and diminished self-worth and may threaten perceptions of femininity Body image of a woman includes the symbolic meaning and importance of her breasts. The more she values her breasts, more devastating effects of having a mastectomy can be. it has been reported that cutting off/amputating one or both breasts was associated with several problems in women such as loss of fertility, charm and sexuality, fear of recurrence Social support plays an important role in reducing the pressure and improving health. Cancer patients who lack social support may be more pessimistic and desperate as they are constantly looking for support from others Therefore, it is critical for health care professionals to become familiar with the impact of a breast cancer diagnosis and its treatment on patient's quality of life .

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
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

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

April 27, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

April 27, 2021

Last Update Submit

April 29, 2021

Conditions

Keywords

Mastectomybreast cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of life post mastectomy

    To evaluate the impact of breast cancer on the quality of life

    6 months

Secondary Outcomes (1)

  • Stages of breast cancer and emotional security

    6 months

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

female patient between 18y and 55y with first-time breast cancer diagnosis and post-operative mastectomized patients

You may qualify if:

  • female patient between 18y and 55y
  • a first-time breast cancer diagnosis
  • post-operative mastectomized patients
  • clear consent to participate in study

You may not qualify if:

  • male gender
  • females patient with concurrent comorbid psychiatric or neurological disorders
  • age younger than 18y
  • patients with disease recurrence, patients presenting with other malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Asmaa Omar, Master

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 5, 2021

Study Start

June 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 31, 2021

Last Updated

May 5, 2021

Record last verified: 2021-04