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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 105

Contacts and Locations

• Study Contact: Name: Alayne Domingues Yamada, PhD; Phone Number: +55 11 98141-7613; Email: alayne.pesquisa@ibcc-mooca.org.br
• Study Contact Backup: Name: Thiago Brito, MD; Phone Number: +55 21 97154-0865; Email: tcgvidal@hotmail.com

Study Locations

• Brazil
  • São Paulo, Brazil, 03102002
    • Recruiting
    • IBCC Oncologia
    • Contact: Thiago Vidal Brito, MD; Phone Number: +55 21 97154-0865; Email: tcgvidal@hotmail.com
    • Contact: Felipe José Silva Melo Cruz, PhD; Phone Number: +5511994466537; Email: felipemcruz@yahoo.com.br
    • Principal Investigator: Thiago Vidal Brito, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;
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;

Collaborators and Investigators

• Sponsor: Instituto Brasileiro de Controle do Cancer

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Oncology; Survivorship
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 32155120.7.0000.0072

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No