Education and Health in Women With Cervical Cancer

NCT07581873 | Active Not Recruiting

• 1 other identifier: 77929624.5.0000.5087
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cervical Cancer; Cervical Cancer Screening; Cervical Cancer Prevention

Keywords

Neoplasia; quality of life; Health Education

Outcome Measures

Primary Outcomes (3)

• Lifestyle

  Lifestyle assessment will be performed using the Individual Lifestyle Profile Questionnaire (ILPQ) by Nahas, Barros, and Francalacci.

  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).

  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.

  From the beginning of treatment to the end, in 12 weeks.

Secondary Outcomes (3)

• Anxiety and Depression

  From the beginning of treatment to the end, in 12 weeks.

• Self-Esteem

  From the beginning of treatment to the end, in 12 weeks.

• Eating Behavior

  From the beginning of treatment to the end, in 12 weeks.

Study Arms (2)

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.

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.

Interventions

Health Education Recommendations Group BEHAVIORAL

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.

Health education recommendations group (GRES)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal University of Maranhao: lead

Study Sites (1)

Federal University of Maranhão

São Luís, Maranhão, Brazil

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms; Health Education

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in the graduate program in Physical Education at the Federal University of Maranhão MA, Brazil

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: May 20, 2025
• Primary Completion: May 20, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)