- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07581873
Education and Health in Women With Cervical Cancer
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maranhão
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São Luís, Maranhão, Brazil
- Federal University of Maranhao
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Health education recommendations group (GRES)
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.
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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.
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No Intervention: Control Group (CG)
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lifestyle
Time Frame: From enrollment to end of treatment at 12 weeks
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Lifestyle assessment will be performed using the Individual Lifestyle Profile Questionnaire (ILPQ) by Nahas, Barros, and Francalacci.
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From enrollment to end of treatment at 12 weeks
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Sedentary behavior
Time Frame: From the beginning of treatment to the end, in 12 weeks.
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Sedentary behavior will be assessed using the "Longitudinal Aging Study Amsterdam - Sedentary Behavior Questionnaire" (LASA-SBQ).
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From the beginning of treatment to the end, in 12 weeks.
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Level of Physical Activity
Time Frame: From the beginning of treatment to the end, in 12 weeks.
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The International Physical Activity Questionnaire (IPAQ - short version) is an instrument used to examine and verify the level of physical activity.
|
From the beginning of treatment to the end, in 12 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety and Depression
Time Frame: From the beginning of treatment to the end, in 12 weeks.
|
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire.
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From the beginning of treatment to the end, in 12 weeks.
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Self-Esteem
Time Frame: From the beginning of treatment to the end, in 12 weeks.
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The validated Rosenberg Self-Esteem Scale (RSES) questionnaire will be used to assess self-esteem.
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From the beginning of treatment to the end, in 12 weeks.
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Eating Behavior
Time Frame: From the beginning of treatment to the end, in 12 weeks.
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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.
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From the beginning of treatment to the end, in 12 weeks.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Neoplasms
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Patient Compliance
- Patient Acceptance of Health Care
- Adherence Interventions
- Medication Adherence
- Neoplasms
- Uterine Cervical Neoplasms
- Health Education
Other Study ID Numbers
- 77929624.5.0000.5087
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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