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Trial Title:
Health Education for Women With Breast Cancer
NCT ID:
NCT05873296
Condition:
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Neoplasms
Sedentary Behavior
Lifestyle
Health Education
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Participant)
Intervention:
Intervention type:
Behavioral
Intervention name:
Health Education
Description:
The intervention will last for 12 weeks, a health education program (face-to-face
meetings and information in social networks).
Arm group label:
Health Education
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%.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Andréa Dias Reis
Address:
City:
São Luís
Zip:
65058185
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Andréa D Reis, PhD
Start date:
July 1, 2023
Completion date:
December 30, 2023
Lead sponsor:
Agency:
Federal University of Maranhao
Agency class:
Other
Source:
Federal University of Maranhao
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05873296
https://www.cancer.org/cancer/breast-cancer/treatment.html
https://www.who.int/pt/news/item/03-02-2021-breast-cancer-now-most-common-form-of-cancer-who-taking-action
