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

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ClinicalTrials.gov Identifier: NCT04834570
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Thiago Vidal Brito, Instituto Brasileiro de Controle do Cancer

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.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: Quality of life in Breast Cancer Survivors

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.

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Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breast Cancer Survivors: Main Physical and Psychosocial Problems After Completion of Treatment
Actual Study Start Date : October 5, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Behavioral: 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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) [ Time Frame: 1 year after treatment ends; 2 years after treatment ends; ]
    The questionnaire contains 23-item, two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.

  2. Quality of life by FACT-B+4 (Functional Assessment of Cancer Therapy-Breast) [ Time Frame: 1 year after treatment ends; 2 years after treatment ends; ]
    The FACT-B+4 questionnaire (Functional Assessment of Cancer Therapy-Breast) consists of 40 questions: 27 about general quality of Life and 13 about breast cancer. It is fur-ther structured into five subscales: physical, family-social, emotional, functional well-being and a last part specific for breast cancer. The result given by the sum of the scores goes from zero to 164: a higher score corresponds to major well-being of the patient.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Recruitment of 100 breast cancer patients who have completed treatment within a minimum of 1 year and are currently undergoing outpatient follow-up
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04834570


Contacts
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Contact: Thiago Brito, MD +55 21 97154-0865 tcgvidal@hotmail.com
Contact: Alayne Domingues Yamada, PhD +55 11 98141-7613 alayne.pesquisa@ibcc-mooca.org.br

Locations
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Brazil
IBCC Oncologia Recruiting
São Paulo, Brazil, 03102002
Contact: Thiago Vidal Brito, MD    +55 21 97154-0865    tcgvidal@hotmail.com   
Contact: Felipe José Silva Melo Cruz, PhD    +5511994466537    felipemcruz@yahoo.com.br   
Principal Investigator: Thiago Vidal Brito, MD         
Sponsors and Collaborators
Instituto Brasileiro de Controle do Cancer
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Responsible Party: Thiago Vidal Brito, Principal Investigator, Instituto Brasileiro de Controle do Cancer
ClinicalTrials.gov Identifier: NCT04834570    
Other Study ID Numbers: 32155120.7.0000.0072
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thiago Vidal Brito, Instituto Brasileiro de Controle do Cancer:
Quality of life
Survivorship
Oncology
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases