Health Education for Women With Breast Cancer

Study Overview
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Brief Summary
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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
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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%.

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

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Education<br>Group of women being treated for breast cancer | Behavioral: Health Education<br>* The intervention will last for 12 weeks, a health education program (face-to-face meetings and information in social networks).<br>|
| No Intervention: usual care<br>Group of women who will remain in usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life habits | Lifestyle will be evaluated by Individual Lifestyle Profile Questionnaire | Change from baseline, 6 weeks Life habits at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition (lean mass, fat mass) | Body Composition will be evaluated by Sanny Tetrapolar Bioimpedance (Model 1011) | 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 | 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. | 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) | 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) | 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) | 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) | 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) | Change from baseline, 6 weeks Eating habits at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Neoplasms, Sedentary Behavior, Lifestyle, Health Education