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Status unknownNCT04834570Updated Apr 8, 2021

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

An observational study in Breast Cancer, sponsored by Instituto Brasileiro de Controle do Cancer. Status unknown at 1 site in Brazil. Open to female participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-04-08.

Sponsored by Instituto Brasileiro de Controle do Cancer · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
105
Ages
20 Years to 60 Years
Sex
Female
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Study 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.

Read the 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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Conditions studied

  • Breast Cancer

Keywords

  • Quality of life
  • Survivorship
  • Oncology
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In context

Breast Neoplasms

12,828 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.

This study's planned enrollment of 105 is below the median of 185 across 2,712 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Instituto Brasileiro de Controle do Cancer is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
105 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • BehavioralQuality 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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year after treatment ends; 2 years after treatment ends;

Secondary outcomes

  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)

    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.

    Time frame: 1 year after treatment ends; 2 years after treatment ends;

  2. 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.

    Time frame: 1 year after treatment ends; 2 years after treatment ends;

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Study locations

1 of 1 sites recruiting
  • IBCC Oncologia
    São Paulo, 03102002, Brazil
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04834570
Lead sponsor
Instituto Brasileiro de Controle do Cancer
Responsible party
Thiago Vidal Brito (Principal Investigator, Instituto Brasileiro de Controle do Cancer) — Principal investigator
First posted
Apr 8, 2021
Start date
Oct 5, 2020
Primary completion
Nov 1, 2021 (estimated)
Completion
Nov 1, 2022 (estimated)
Last update
Apr 8, 2021

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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