Breast Cancer FemaleNCT05873296
Health Education for Women With Breast Cancer
A study testing Health Education in people with Breast Cancer Female, run by Federal University of Maranhao at 1 site in Brazil.
Trial summary
The sedentary lifestyle in women with breast cancer generates a problem for public health. An alternative that has been used to reduce sedentary behavior are interventions with the use of information technology, as well as projects with health education can cause lifestyle changes. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2023to 30 Dec 2024
- Phase
- Interventional
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women 18 years or older;
- Diagnosed with breast cancer;
- Ongoing breast cancer treatment (chemotherapy, radiotherapy and/or hormone therapy);
- Have daily access to a smartphone.
Who cannot join
- Women having another type of cancer;
- Perform physical training for three months before the intervention;
- Has medical contraindication to perform any type of physical activity;
- Have filled in yes on the PAR-Q and medical contraindication;
- Without cognitive conditions to use a smartphone or answer questionnaires;
- Illiterate women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Health Education on Lifestyle for Women With Breast Cancer: Health Education
The sedentary lifestyle in women with breast cancer generates a problem for public health. An alternative that has been used to reduce sedentary behavior are interventions with the use of information technology, as well as projects with health education can cause lifestyle changes. However, little is known about the effect of these interventions on self-awareness and self-care in women with breast cancer. This aim of study is evaluate the effect of health education on sedentary behavior, lifestyle, physical activity level, nutrition, self-esteem, anxiety and depression, quality of life, pain, functional capacity, and strength in women with breast cancer. This is a study the 12 weeks, with patients being treated for breast cancer, distributed for two groups: Group Health Education Recommendations and Control Group.
Read the detailed description
This is a clinical trial with patients being treated for breast cancer, the sample will be randomly distributed into two groups: Group Health Education Recommendations (GRES) and Control Group (CG), which will remain in usual care. The intervention will last for 12 weeks, where GRES will receive health education recommendations in person and via social media. The endpoints of this study are sedentary behavior, lifestyle, physical activity level, nutrition, self-esteem, anxiety and depression, quality of life, pain, functional capacity, and strength. Evaluations will be performed at baseline, after 6 weeks, and after 12 weeks. Data will be analyzed by multivariate, comparing the effects of group, time, and interaction in SPSS software version 24.0, with α=5%.
- Conditions
- Breast Cancer Female
- Being tested
- Health Education
- Keywords
- Breast Neoplasms, Sedentary Behavior, Lifestyle, Health Education
- Medical subject headings
- Breast Neoplasms, Sedentary Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
The intervention will last for 12 weeks, a health education program (face-to-face meetings and information in social networks).
| Study group | Role | What they receive |
|---|---|---|
| Health Education | Experimental | Group of women being treated for breast cancer Receives: Behavioral: Health Education |
| usual care | No intervention | Group of women who will remain in usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life habits
Lifestyle will be evaluated by Individual Lifestyle Profile Questionnaire (score 0 to 3 - higher score is better)
Measured: Change from baseline, 6 weeks Life habits at 12 weeks
Secondary outcomes (8)
Body composition (lean mass, fat mass)
Body Composition will be evaluated by Sanny Tetrapolar Bioimpedance (Model 1011)
Measured: Change from baseline, 6 weeks Body composition at 12 weeks
Sitting time
Sedentary behavior will be evaluated by triaxial accelerometers motion sensor Actigraph GT3X model
Measured: Change from baseline, 6 weeks Sitting time at 12 weeks
Time and level the physical activity
Physical activity level will be evaluated by triaxial accelerometers motion sensor Actigraph, GT3X model.
Measured: Change from baseline, 6 weeks Time and level the physical activity at 12 weeks
Level the self-esteem
Self-esteem will be evaluated by Rosenberg Self-Esteem Scale (score 1 to 4 - higher score is better and worse outcome, depends on the question)
Measured: Change from baseline, 6 weeks Level the self-esteem at 12 weeks
Dimensions the quality of Life from cancer
Quality of Life will be evaluated by European Organization for Research and Treatment of Cancer Quality of Life Questionnarie - 30 questions (score 1 to 4 - higher score is worse outcome)
Measured: Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks
Dimensions the quality of Life from breast cancer
Quality of Life will be evaluated by European Organization for Research and Treatment of Cancer Quality of Life Questionnarie - 23 questions (score 1 to 4 - higher score is worse outcome)
Measured: Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks
Level the pain
Pain will be evaluated by Brief Pain Inventory (score 1 to 10 - higher score is worse outcome)
Measured: Change from baseline, 6 weeks Level the pain at 12 weeks
Eating habits
Eating behavior will be evaluated by (score 1 to 4 - higher score is better outcome)
Measured: Change from baseline, 6 weeks Eating habits at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jul 2023
- Primary completion30 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Maranhao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andréa Dias Reis, Federal University of Maranhao
- Investigators
- Andréa D Reis, Principal investigator, Federal University of Maranhão
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873296
- Sponsor's protocol ID
- UFMA
- Status last verified
- Dec 2025
- First submitted
- 22 Mar 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Health Education on Lifestyle for Women With Breast Cancer: Health Education
- ClinicalTrials.gov ID
- NCT05873296
- Acronym / sponsor ID
- UFMA
- Conditions
- Breast Cancer Female
- Keywords
- Breast Neoplasms, Sedentary Behavior, Lifestyle, Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Federal University of MaranhaoUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 24 May 2023 (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.
The sedentary lifestyle in women with breast cancer generates a problem for public health. An alternative that has been used to reduce sedentary behavior are interventions with the use of information technology, as well as projects with health education can cause lifestyle changes. However, little is known about the effect of these interventions on self-awareness and self-care in women with breast cancer. This aim of study is evaluate the effect of health education on sedentary behavior, lifestyle, physical activity level, nutrition, self-esteem, anxiety and depression, quality of life, pain, functional capacity, and strength in women with breast cancer. This is a study the 12 weeks, with patients being treated for breast cancer, distributed for two groups: Group Health Education Recommendations and Control Group.
Detailed description
This is a clinical trial with patients being treated for breast cancer, the sample will be randomly distributed into two groups: Group Health Education Recommendations (GRES) and Control Group (CG), which will remain in usual care. The intervention will last for 12 weeks, where GRES will receive health education recommendations in person and via social media. The endpoints of this study are sedentary behavior, lifestyle, physical activity level, nutrition, self-esteem, anxiety and depression, quality of life, pain, functional capacity, and strength. Evaluations will be performed at baseline, after 6 weeks, and after 12 weeks. Data will be analyzed by multivariate, comparing the effects of group, time, and interaction in SPSS software version 24.0, with α=5%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Education | Experimental | Behavioral: Health EducationGroup of women being treated for breast cancer |
| usual care | No intervention | –Group of women who will remain in usual care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women 18 years or older;
- Diagnosed with breast cancer;
- Ongoing breast cancer treatment (chemotherapy, radiotherapy and/or hormone therapy);
- Have daily access to a smartphone.
Key exclusion criteria (6 listed)
- Women having another type of cancer;
- Perform physical training for three months before the intervention;
- Has medical contraindication to perform any type of physical activity;
- Have filled in yes on the PAR-Q and medical contraindication;
- Without cognitive conditions to use a smartphone or answer questionnaires;
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 |
|---|---|---|
| Health EducationThe intervention will last for 12 weeks, a health education program (face-to-face meetings and information in social networks). | Behavioural | Health Education |
Primary outcome
Life habits
Time frame: Change from baseline, 6 weeks Life habits at 12 weeks
Lifestyle will be evaluated by Individual Lifestyle Profile Questionnaire (score 0 to 3 - higher score is better)
8 secondary outcomes
Body composition (lean mass, fat mass)
Time frame: Change from baseline, 6 weeks Body composition at 12 weeks
Sitting time
Time frame: Change from baseline, 6 weeks Sitting time at 12 weeks
Time and level the physical activity
Time frame: Change from baseline, 6 weeks Time and level the physical activity at 12 weeks
Level the self-esteem
Time frame: Change from baseline, 6 weeks Level the self-esteem at 12 weeks
Dimensions the quality of Life from cancer
Time frame: Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks
Dimensions the quality of Life from breast cancer
Time frame: Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks
Level the pain
Time frame: Change from baseline, 6 weeks Level the pain at 12 weeks
Eating habits
Time frame: Change from baseline, 6 weeks Eating habits at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- AMERICAN CANCER SOCIETYLink provided by the sponsor.
- World Health OrganizationLink provided by the sponsor.
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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.
Andréa D Reis principal investigator
Federal University of Maranhão
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education in people with Breast Cancer Female, run by Federal University of Maranhao 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 10 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life habits (time frame: Change from baseline, 6 weeks Life habits at 12 weeks). 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 10 Dec 2025.