NCT04834570

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

April 1, 2021

Last Update Submit

April 6, 2021

Conditions

Breast Cancer

Keywords

Quality of lifeSurvivorshipOncology

Outcome Measures

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.

    1 year after treatment ends; 2 years after treatment ends;

Secondary Outcomes (2)

  • 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)

    1 year after treatment ends; 2 years after treatment ends;

  • Quality of life by FACT-B+4 (Functional Assessment of Cancer Therapy-Breast)

    1 year after treatment ends; 2 years after treatment ends;

Study Arms (1)

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

Quality of life in Breast Cancer SurvivorsBEHAVIORAL

The patient will receive the following questionnaires to be completed : * EORTC QLQ-C30 * EORTC QLQ - BR-23 * FACT-B

Breast Cancer Survivors

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IBCC Oncologia

São Paulo, 03102002, Brazil

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Central Study Contacts

Thiago Brito, MD

CONTACT

+55 21 97154-0865tcgvidal@hotmail.com

Alayne Domingues Yamada, PhD

CONTACT

+55 11 98141-7613alayne.pesquisa@ibcc-mooca.org.br

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 8, 2021

Study Start

October 5, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2022

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

BR(1)