Breast CancerNCT04834570
Breast Cancer Survivors: Main Physical and Psychosocial Problems After Completion of Treatment
An observational study of Breast Cancer, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Quality of life in Breast Cancer Survivors
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 105 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Oct 2020to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
IBCC Oncologia
São Paulo, 03102002
Thiago Vidal Brito, MD, +55 21 97154-0865, tcgvidal@hotmail.com
Felipe José Silva Melo Cruz, PhD, +5511994466537, felipemcruz@yahoo.com.br
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- Quality of life in Breast Cancer Survivors
- Keywords
- Quality of life, Survivorship, Oncology
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life in Breast Cancer SurvivorsBehavioural
The patient will receive the following questionnaires to be completed :
- EORTC QLQ-C30
- EORTC QLQ - BR-23
- FACT-B
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Quality of life in Breast Cancer Survivors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 1 year after treatment ends; 2 years after treatment ends;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start5 Oct 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Brasileiro de Controle do Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thiago Vidal Brito, Instituto Brasileiro de Controle do Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834570
- Sponsor's protocol ID
- 32155120.7.0000.0072
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Survivors: Main Physical and Psychosocial Problems After Completion of Treatment
- ClinicalTrials.gov ID
- NCT04834570
- Acronym / sponsor ID
- 32155120.7.0000.0072
- Conditions
- Breast Cancer
- Keywords
- Quality of life, Survivorship, Oncology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Instituto Brasileiro de Controle do CancerUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Survivors | – | Behavioral: Quality of life in Breast Cancer SurvivorsWomen who have survived breast cancer for at least 1 year (12 months) and 2 years (24 months) after the end of primary treatment |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life in Breast Cancer SurvivorsThe patient will receive the following questionnaires to be completed : * EORTC QLQ-C30 * EORTC QLQ - BR-23 * FACT-B | Behavioural | Breast Cancer Survivors |
Primary outcome
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.
2 secondary outcomes
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;
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;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thiago Brito, MD (+55 21 97154-0865, tcgvidal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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;). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.