Breast Cancer Female
Conditions
Keywords
Breast Neoplasms, Sedentary Behavior, Lifestyle, Health Education
Brief summary
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
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%.
Interventions
BEHAVIORALHealth Education
The intervention will last for 12 weeks, a health education program (face-to-face meetings and information in social networks).
Sponsors
Federal University of Maranhao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Life habits | 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
| Measure | Time frame | Description |
|---|---|---|
| Body composition (lean mass, fat mass) | Change from baseline, 6 weeks Body composition at 12 weeks | Body Composition will be evaluated by Sanny Tetrapolar Bioimpedance (Model 1011) |
| Sitting time | Change from baseline, 6 weeks Sitting time at 12 weeks | Sedentary behavior will be evaluated by triaxial accelerometers motion sensor Actigraph GT3X model |
| Level the self-esteem | 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) |
| Time and level the physical activity | 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. |
| Dimensions the quality of Life from breast cancer | 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) |
| Level the pain | 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) |
| Eating habits | 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) |
| Dimensions the quality of Life from cancer | 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) |
Countries
Brazil
Outcome results
None listed