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Completed

NCT Number: NCT05873296

Health Education for Women With Breast Cancer

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.

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Key information

Conditions

Breast Cancer Female Adherence Interventions Behavior Breast Diseases Breast Neoplasms Health Behavior Health Education Medication Adherence Neoplasms Neoplasms by Site Patient Acceptance of Health Care Patient Compliance Sedentary Behavior Skin Diseases Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Andréa Dias Reis

São Luís, Maranhão, 65058185, Brazil

About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Health Education

Behavioral

The intervention will last for 12 weeks, a health education program (face-to-face meetings and information in social networks).

Primary outcomes

  1. 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)

Secondary outcomes

  1. Body composition (lean mass, fat mass)

    Time frame: Change from baseline, 6 weeks Body composition at 12 weeks

    Body Composition will be evaluated by Sanny Tetrapolar Bioimpedance (Model 1011)

  2. Sitting time

    Time frame: Change from baseline, 6 weeks Sitting time at 12 weeks

    Sedentary behavior will be evaluated by triaxial accelerometers motion sensor Actigraph GT3X model

  3. Time and level the physical activity

    Time frame: Change from baseline, 6 weeks Time and level the physical activity at 12 weeks

    Physical activity level will be evaluated by triaxial accelerometers motion sensor Actigraph, GT3X model.

  4. Level the self-esteem

    Time frame: Change from baseline, 6 weeks Level the self-esteem at 12 weeks

    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)

  5. Dimensions the quality of Life from cancer

    Time frame: Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks

    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)

  6. Dimensions the quality of Life from breast cancer

    Time frame: Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks

    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)

  7. Level the pain

    Time frame: Change from baseline, 6 weeks Level the pain at 12 weeks

    Pain will be evaluated by Brief Pain Inventory (score 1 to 10 - higher score is worse outcome)

  8. Eating habits

    Time frame: Change from baseline, 6 weeks Eating habits at 12 weeks

    Eating behavior will be evaluated by (score 1 to 4 - higher score is better outcome)

Sponsors and collaborators

Lead sponsor

Federal University of Maranhao

Other

Registry information

Official study title

Impact of Health Education on Lifestyle for Women With Breast Cancer: Health Education

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 24, 2023
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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