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Clinical Trials/NCT04834570
NCT04834570
Unknown
Not Applicable

Breast Cancer Survivors: Main Physical and Psychosocial Problems After Completion of Treatment

Instituto Brasileiro de Controle do Cancer1 site in 1 country105 target enrollmentOctober 5, 2020
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Instituto Brasileiro de Controle do Cancer
Enrollment
105
Locations
1
Primary Endpoint
Change in Global Health Status by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire)
Last Updated
5 years ago

Overview

Brief Summary

Breast cancer directly affects women physically, psychologically and socially in the process of diagnosis, treatment and post-treatment. Despite the improvement in conventional breast cancer treatments that led to longer disease-free survival, many patients still suffer from physical, psychological, social and spiritual problems after treatment. The neglect of physical and psychosocial problems faced by patients who are between 1 and 2 years after the end of treatment negatively impacts the quality of life of this population.

Detailed Description

The purpose of the study is to assess the overall quality of life and measure the impact on women who have survived breast cancer for at least 1 year (12 months) and 2 years (24 months) after the end of primary treatment and to identify possible repercussions of breast cancer and its treatments associated with Quality of Life.

Registry
clinicaltrials.gov
Start Date
October 5, 2020
End Date
November 1, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thiago Vidal Brito

Principal Investigator

Instituto Brasileiro de Controle do Cancer

Eligibility Criteria

Inclusion Criteria

  • Breast cancer
  • Adult women (age ≥ 20 years old and less than 60 years old)
  • Patient who has been treated by surgery, with or without adjuvant chemotherapy
  • Clinical Stages I, II and III
  • Patients considered cured, without history of recurrences
  • Patients who completed treatment within a minimum of 1 year and are currently being undergoing outpatient follow-up

Exclusion Criteria

  • Initial diagnosis of another type of cancer, other than breast cancer
  • Bilateral breast cancer
  • Patient unable to fill out the QoL questionnaire
  • Patient with disease recurrence
  • Patient with metastatic breast cancer

Outcomes

Primary Outcomes

Change in Global Health Status by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire)

Time Frame: 1 year after treatment ends; 2 years after treatment ends;

This questionnaire was designed to be cancer specific, and includes all emotional, social and physical aspects of the individual's life. The scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100, with 0 denoting the negative (low functioning, high symptom burden) and 100 the positive end (high functioning, low symptom burden) of the continuum.

Secondary Outcomes

  • Quality of life specific for breast cancer by EORTC QLQ-BR23 (European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire)(1 year after treatment ends; 2 years after treatment ends;)
  • Quality of life by FACT-B+4 (Functional Assessment of Cancer Therapy-Breast)(1 year after treatment ends; 2 years after treatment ends;)

Study Sites (1)

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