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
|Condition or disease||Intervention/treatment|
|Breast Cancer||Behavioral: Quality of life in Breast Cancer Survivors|
|Study Type :||Observational|
|Estimated Enrollment :||105 participants|
|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|
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 :
- 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.
- 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.
- 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.
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
|Contact: Thiago Brito, MD||+55 21 firstname.lastname@example.org|
|Contact: Alayne Domingues Yamada, PhD||+55 11 email@example.com|