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

NCT ID: NCT04834570

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-05

Study Completion Date

2022-11-01

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast Cancer Survivors

Women who have survived breast cancer for at least 1 year (12 months) and 2 years (24 months) after the end of primary treatment

Quality of life in Breast Cancer Survivors

Intervention Type BEHAVIORAL

The patient will receive the following questionnaires to be completed :

* EORTC QLQ-C30
* EORTC QLQ - BR-23
* FACT-B

Interventions

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Quality of life in Breast Cancer Survivors

The patient will receive the following questionnaires to be completed :

* EORTC QLQ-C30
* EORTC QLQ - BR-23
* FACT-B

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Brasileiro de Controle do Cancer

OTHER

Sponsor Role lead

Responsible Party

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Thiago Vidal Brito

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IBCC Oncologia

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Thiago Brito, MD

Role: CONTACT

+55 21 97154-0865

Alayne Domingues Yamada, PhD

Role: CONTACT

+55 11 98141-7613

Facility Contacts

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Thiago Vidal Brito, MD

Role: primary

+55 21 97154-0865

Felipe José Silva Melo Cruz, PhD

Role: backup

+5511994466537

Other Identifiers

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32155120.7.0000.0072

Identifier Type: -

Identifier Source: org_study_id

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