Cervical CancerNCT07581873
Education and Health in Women With Cervical Cancer
A study testing Health Education Recommendations Group in people with Cervical Cancer and Cervical Cancer Screening, run by Federal University of Maranhao at 1 site in Brazil.
Trial summary
Introduction: Cervical neoplasms constitute a significant public health problem on a global scale. According to the National Cancer Institute, this pathology is the third most prevalent type of cancer among women in Brazil, and the second most incident neoplasm in the North and Northeast regions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cervical Cancer Screening, Cervical Cancer Prevention
- What is being tested?
- Health Education Recommendations Group
- 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
- 20 May 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 or older;
- Diagnosed with cervical cancer;
- Undergoing cervical cancer treatment (chemotherapy, radiotherapy, and/or hormone therapy);
- Having daily access to a smartphone.
Who cannot join
- Having another type of cancer;
- Undertake physical training for three months prior to the intervention;
- Have a medical contraindication to perform any type of physical activity;
- Have a "yes" answer on the PAR-Q and a medical contraindication;
- Not be mentally capable of using a smartphone or answering the research questionnaires;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Health Education on Lifestyle of Women With Cervical Cancer: Education of Health
Introduction: Cervical neoplasms constitute a significant public health problem on a global scale. According to the National Cancer Institute, this pathology is the third most prevalent type of cancer among women in Brazil, and the second most incident neoplasm in the North and Northeast regions. Estimates for each year of the 2023-2025 triennium point to approximately 17,010 new cases, with a gross incidence rate of 15.38 cases per 100,000 women. Health education emerges as a fundamental strategy in promoting healthy behaviors and building critical awareness of the health-disease process, considering individual and collective particularities.
Objective: To evaluate the effect of health education on the level of quality of life, physical activity, self-esteem, anxiety, depression, nutrition, and pain in women with cervical cancer.
Materials and Methods: This is a clinical trial with cervical cancer patients. The sample will be randomly distributed into two groups: the Health Education Recommendations Group (HERG) and the Control Group (CG), which will remain under usual care. The intervention will last 12 weeks, during which the HERG will receive health education recommendations through face-to-face meetings and via social media. The variables in this study are the participants' sociodemographic and clinical profile, lifestyle, sedentary behavior, level of physical activity, nutrition, self-esteem, anxiety and depression, quality of life, and pain. The variables of interest will be evaluated at baseline, after 6 and 12 weeks through multivariate analysis, comparing the effects of group, time, and interaction of both. Analyses will be performed using SPSS version 24.0 software, with a significance level of 5%. Expected results: Lifestyle change in at least two addressed areas. The developed material contributes to the scientific literature through the creation of textbooks, articles, and by offering valuable insights into the effectiveness of health education strategies. Future research can expand this work, adapting it to other populations or contexts to maximize its impact.
Read the detailed description
Cervical neoplasms represent a significant public health problem on a global scale. In Brazil, they constitute the third most frequent type of cancer among women of reproductive age. This condition is caused by cellular alterations, mainly triggered by persistent infection with oncogenic subtypes of Human Papillomavirus (HPV). Cervical cancer, also called cervical cancer, results from continuous infection with oncogenic types of HPV. Although genital infection with these viruses is common and, in most cases, does not result in disease, some situations evolve into cellular changes that can progress to cancer.
Two main types of invasive carcinomas are identified, according to the origin of the affected epithelium: squamous cell carcinoma, the most prevalent, which affects the squamous epithelium and represents approximately 90% of cases, and adenocarcinoma, less frequent, which affects the glandular epithelium and corresponds to about 10% of cases. Both are associated with persistent infection by oncogenic variants of HPV.Primary prevention of cervical cancer includes the use of condoms and HPV vaccination, complemented by health promotion actions. Secondary prevention, in turn, includes early detection through preventive examination (Papanicolaou or cytopathological), indicated for women between 25 and 64 years of age, especially those who have already started their sexual life.The Pap smear allows for the early detection of abnormal cells, enabling interventions that prevent progression to advanced forms of the disease. Thus, early identification is essential to improve the quality of life of patients. Several factors contribute to the development of cervical cancer, with HPV being the main one, especially subtypes 16 and 18, responsible for approximately 70% of cases. Other risk factors include smoking, multiple unprotected sexual partners, early onset of sexual activity, multiparity, prolonged use of oral contraceptives, history of STIs, and micronutrient deficiencies such as vitamin C, beta-carotene, and folate. The Pan American Health Organization (PAHO) recommends the implementation of national programs that include integrated actions for primary prevention, early detection, treatment, and palliative care, measures that have been adopted in most Latin American countries since the 1980s. However, issues related to access to and quality of health services, as well as the socioeconomic level of women, hinder the control of the disease in the region. In addition, a lack of knowledge about cervical health is a significant barrier to early diagnosis. Therefore, awareness campaigns specifically for women are essential. Health education is an essential tool in promoting healthy behaviors and building a critical awareness of the health-disease process, considering individual and collective realities. By disseminating qualified information, the aim is not only to clarify the determinants of health, but also to provide support for the adoption of preventive practices. Health promotion encompasses multiple levels of intervention, from individual care and community work to strategic actions aimed at public policies. Educational interventions addressing HPV and Sexually Transmitted Infections (STIs) are fundamental for the prevention of cervical cancer and should consider sociocultural and economic aspects to reduce barriers related to early diagnosis. The use of new technologies, such as mHealth strategies, has shown promise in increasing adherence to preventive practices. These interventions, especially for chronic diseases such as cervical cancer, facilitate screening, monitoring, and dissemination of information in an economical and efficient way. In addition, social media has the potential to influence behaviors by promoting discussions, disseminating information rapidly, and reaching a wide audience at low cost. Therefore, the combined use of health education and digital technologies can significantly contribute to the prevention and control of cervical cancer. Furthermore, social media has the potential to influence behaviors by promoting discussions, disseminating information rapidly, and reaching a wide audience at low cost. Therefore, the combined use of health education and digital technologies can significantly contribute to the prevention and control of cervical cancer. From this perspective, it emphasizes the need for intervention programs with health education for cervical cancer patients, considering the incidence and mortality of cervical cancer in Brazil, especially in the state of Maranhão, Brazil, as no similar study was found in the region.
- Being tested
- Health Education Recommendations Group
- Keywords
- Neoplasia, quality of life, Health Education
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasms, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Education Recommendations GroupBehavioural
In the first meeting, participants will answer a questionnaire called "Sociodemographic and Clinical Profile of Participants," designed to collect essential information about their social characteristics and clinical conditions. After this stage, each participant will receive a detailed booklet containing all the axes of the Education on Health program, which are: Sedentary Behavior, Physical Activity, Healthy Eating, Mental Health (Self-esteem, Self-care and Body Image), Socialization, Physical Health (Illness, Sleep and Hydration). During the 12 weeks of the study, participants will receive periodic recommendations on all the aforementioned themes through messages sent via WhatsApp. Complementary online meetings will also be held for each theme, promoting group activities designed to encourage the exchange of experiences, collaborative learning, and the development of healthy habits.
| Study group | Role | What they receive |
|---|---|---|
| Health education recommendations group (GRES) | Experimental | During the 12 weeks of the study, participants will receive periodic recommendations on all the aforementioned areas, through messages sent via WhatsApp. Complementary online meetings will also be held for each area, promoting group activities designed to stimulate the exchange of experiences, collaborative learning, and the development of healthy habits. Receives: Behavioral: Health Education Recommendations Group |
| Control Group (CG) | No intervention | The CG participants will consist of participants who will receive only the usual care related to routine cancer treatment, as designated by their medical teams. This treatment includes chemotherapy, radiotherapy, surgery, or combined approaches, according to the protocol indicated for each patient. Participants will only answer questionnaires during the baseline assessment periods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifestyle
Lifestyle assessment will be performed using the Individual Lifestyle Profile Questionnaire (ILPQ) by Nahas, Barros, and Francalacci.
Measured: From enrollment to end of treatment at 12 weeks
Sedentary behavior
Sedentary behavior will be assessed using the "Longitudinal Aging Study Amsterdam - Sedentary Behavior Questionnaire" (LASA-SBQ).
Measured: From the beginning of treatment to the end, in 12 weeks.
Level of Physical Activity
The International Physical Activity Questionnaire (IPAQ - short version) is an instrument used to examine and verify the level of physical activity.
Measured: From the beginning of treatment to the end, in 12 weeks.
Secondary outcomes (3)
Anxiety and Depression
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Measured: From the beginning of treatment to the end, in 12 weeks.
Self-Esteem
The validated Rosenberg Self-Esteem Scale (RSES) questionnaire will be used to assess self-esteem.
Measured: From the beginning of treatment to the end, in 12 weeks.
Eating Behavior
Eating behavior will be assessed using the Food Choice Questionnaire (FCQ). The Food Choice Questionnaire (FCQ) contains 36 items distributed across nine dimensions and is a validated instrument for Portuguese.
Measured: From the beginning of treatment to the end, in 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start20 May 2025
- Primary completion20 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581873
- Sponsor's protocol ID
- 77929624.5.0000.5087
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Health Education on Lifestyle of Women With Cervical Cancer: Education of Health
- ClinicalTrials.gov ID
- NCT07581873
- Acronym / sponsor ID
- 77929624.5.0000.5087
- Keywords
- Neoplasia, quality of life, Health Education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Federal University of MaranhaoUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 May 2026 (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.
Introduction: Cervical neoplasms constitute a significant public health problem on a global scale. According to the National Cancer Institute, this pathology is the third most prevalent type of cancer among women in Brazil, and the second most incident neoplasm in the North and Northeast regions. Estimates for each year of the 2023-2025 triennium point to approximately 17,010 new cases, with a gross incidence rate of 15.38 cases per 100,000 women. Health education emerges as a fundamental strategy in promoting healthy behaviors and building critical awareness of the health-disease process, considering individual and collective particularities.
Objective: To evaluate the effect of health education on the level of quality of life, physical activity, self-esteem, anxiety, depression, nutrition, and pain in women with cervical cancer.
Materials and Methods: This is a clinical trial with cervical cancer patients. The sample will be randomly distributed into two groups: the Health Education Recommendations Group (HERG) and the Control Group (CG), which will remain under usual care. The intervention will last 12 weeks, during which the HERG will receive health education recommendations through face-to-face meetings and via social media. The variables in this study are the participants' sociodemographic and clinical profile, lifestyle, sedentary behavior, level of physical activity, nutrition, self-esteem, anxiety and depression, quality of life, and pain. The variables of interest will be evaluated at baseline, after 6 and 12 weeks through multivariate analysis, comparing the effects of group, time, and interaction of both. Analyses will be performed using SPSS version 24.0 software, with a significance level of 5%. Expected results: Lifestyle change in at least two addressed areas. The developed material contributes to the scientific literature through the creation of textbooks, articles, and by offering valuable insights into the effectiveness of health education strategies. Future research can expand this work, adapting it to other populations or contexts to maximize its impact.
Detailed description
Cervical neoplasms represent a significant public health problem on a global scale. In Brazil, they constitute the third most frequent type of cancer among women of reproductive age. This condition is caused by cellular alterations, mainly triggered by persistent infection with oncogenic subtypes of Human Papillomavirus (HPV). Cervical cancer, also called cervical cancer, results from continuous infection with oncogenic types of HPV. Although genital infection with these viruses is common and, in most cases, does not result in disease, some situations evolve into cellular changes that can progress to cancer.
Two main types of invasive carcinomas are identified, according to the origin of the affected epithelium: squamous cell carcinoma, the most prevalent, which affects the squamous epithelium and represents approximately 90% of cases, and adenocarcinoma, less frequent, which affects the glandular epithelium and corresponds to about 10% of cases. Both are associated with persistent infection by oncogenic variants of HPV.Primary prevention of cervical cancer includes the use of condoms and HPV vaccination, complemented by health promotion actions. Secondary prevention, in turn, includes early detection through preventive examination (Papanicolaou or cytopathological), indicated for women between 25 and 64 years of age, especially those who have already started their sexual life.The Pap smear allows for the early detection of abnormal cells, enabling interventions that prevent progression to advanced forms of the disease. Thus, early identification is essential to improve the quality of life of patients. Several factors contribute to the development of cervical cancer, with HPV being the main one, especially subtypes 16 and 18, responsible for approximately 70% of cases. Other risk factors include smoking, multiple unprotected sexual partners, early onset of sexual activity, multiparity, prolonged use of oral contraceptives, history of STIs, and micronutrient deficiencies such as vitamin C, beta-carotene, and folate. The Pan American Health Organization (PAHO) recommends the implementation of national programs that include integrated actions for primary prevention, early detection, treatment, and palliative care, measures that have been adopted in most Latin American countries since the 1980s. However, issues related to access to and quality of health services, as well as the socioeconomic level of women, hinder the control of the disease in the region. In addition, a lack of knowledge about cervical health is a significant barrier to early diagnosis. Therefore, awareness campaigns specifically for women are essential. Health education is an essential tool in promoting healthy behaviors and building a critical awareness of the health-disease process, considering individual and collective realities. By disseminating qualified information, the aim is not only to clarify the determinants of health, but also to provide support for the adoption of preventive practices. Health promotion encompasses multiple levels of intervention, from individual care and community work to strategic actions aimed at public policies. Educational interventions addressing HPV and Sexually Transmitted Infections (STIs) are fundamental for the prevention of cervical cancer and should consider sociocultural and economic aspects to reduce barriers related to early diagnosis. The use of new technologies, such as mHealth strategies, has shown promise in increasing adherence to preventive practices. These interventions, especially for chronic diseases such as cervical cancer, facilitate screening, monitoring, and dissemination of information in an economical and efficient way. In addition, social media has the potential to influence behaviors by promoting discussions, disseminating information rapidly, and reaching a wide audience at low cost. Therefore, the combined use of health education and digital technologies can significantly contribute to the prevention and control of cervical cancer. Furthermore, social media has the potential to influence behaviors by promoting discussions, disseminating information rapidly, and reaching a wide audience at low cost. Therefore, the combined use of health education and digital technologies can significantly contribute to the prevention and control of cervical cancer. From this perspective, it emphasizes the need for intervention programs with health education for cervical cancer patients, considering the incidence and mortality of cervical cancer in Brazil, especially in the state of Maranhão, Brazil, as no similar study was found in the region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health education recommendations group (GRES) | Experimental | Behavioral: Health Education Recommendations GroupDuring the 12 weeks of the study, participants will receive periodic recommendations on all the aforementioned areas, through messages sent via WhatsApp. Complementary online meetings will also be held for each area, promoting group activities designed to stimulate the exchange of experiences, collaborative learning, and the development of healthy habits. |
| Control Group (CG) | No intervention | –The CG participants will consist of participants who will receive only the usual care related to routine cancer treatment, as designated by their medical teams. This treatment includes chemotherapy, radiotherapy, surgery, or combined approaches, according to the protocol indicated for each patient. Participants will only answer questionnaires during the baseline assessment periods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 18 or older;
- Diagnosed with cervical cancer;
- Undergoing cervical cancer treatment (chemotherapy, radiotherapy, and/or hormone therapy);
- Having daily access to a smartphone.
Key exclusion criteria (5 listed)
- Having another type of cancer;
- Undertake physical training for three months prior to the intervention;
- Have a medical contraindication to perform any type of physical activity;
- Have a "yes" answer on the PAR-Q and a medical contraindication;
- Not be mentally capable of using a smartphone or answering the research 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 Education Recommendations GroupIn the first meeting, participants will answer a questionnaire called "Sociodemographic and Clinical Profile of Participants," designed to collect essential information about their social characteristics and clinical conditions. After this stage, each participant will receive a detailed booklet containing all the axes of the Education on Health program, which are: Sedentary Behavior, Physical Activity, Healthy Eating, Mental Health (Self-esteem, Self-care and Body Image), Socialization, Physical Health (Illness, Sleep and Hydration). During the 12 weeks of the study, participants will receive periodic recommendations on all the aforementioned themes through messages sent via WhatsApp. Complementary online meetings will also be held for each theme, promoting group activities designed to encourage the exchange of experiences, collaborative learning, and the development of healthy habits. | Behavioural | Health education recommendations group (GRES) |
Primary outcome
Lifestyle
Time frame: From enrollment to end of treatment at 12 weeks
Lifestyle assessment will be performed using the Individual Lifestyle Profile Questionnaire (ILPQ) by Nahas, Barros, and Francalacci.
Sedentary behavior
Time frame: From the beginning of treatment to the end, in 12 weeks.
Sedentary behavior will be assessed using the "Longitudinal Aging Study Amsterdam - Sedentary Behavior Questionnaire" (LASA-SBQ).
Level of Physical Activity
Time frame: From the beginning of treatment to the end, in 12 weeks.
The International Physical Activity Questionnaire (IPAQ - short version) is an instrument used to examine and verify the level of physical activity.
3 secondary outcomes
Anxiety and Depression
Time frame: From the beginning of treatment to the end, in 12 weeks.
Self-Esteem
Time frame: From the beginning of treatment to the end, in 12 weeks.
Eating Behavior
Time frame: From the beginning of treatment to the end, in 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Recommendations Group in people with Cervical Cancer and Cervical Cancer Screening, 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 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Lifestyle (time frame: From enrollment to end of treatment at 12 weeks). The study lists 3 primary outcomes in all. 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 14 May 2026.