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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04834570
• Other study ID #: 32155120.7.0000.0072
• Status: Recruiting
• Start date: October 5, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: April 2021
• Source: Instituto Brasileiro de Controle do Cancer
• Contact: Thiago Brito, MD
• Phone: +55 21 97154-0865
• Email: tcgvidal[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Brazil	IBCC Oncologia	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Brasileiro de Controle do Cancer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Global Health Status by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire)	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.	1 year after treatment ends; 2 years after treatment ends;
Secondary	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)	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.	1 year after treatment ends; 2 years after treatment ends;
Secondary	Quality of life by FACT-B+4 (Functional Assessment of Cancer Therapy-Breast)	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.	1 year after treatment ends; 2 years after treatment ends;