Clinical trial NCT05873296: Health Education for Women With Breast Cancer
Official title: Impact of Health Education on Lifestyle for Women With Breast Cancer: Health Education
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Female
Keywords: Breast Neoplasms
Sedentary Behavior
Lifestyle
Health Education
Lead sponsor: Federal University of Maranhao
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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%.

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.

Primary outcomes:
measure: Life habits
timeFrame: Change from baseline, 6 weeks Life habits at 12 weeks
Secondary outcomes:
measure: Body composition (lean mass, fat mass)
timeFrame: Change from baseline, 6 weeks Body composition at 12 weeks
measure: Sitting time
timeFrame: Change from baseline, 6 weeks Sitting time at 12 weeks
measure: Time and level the physical activity
timeFrame: Change from baseline, 6 weeks Time and level the physical activity at 12 weeks
measure: Level the self-esteem
timeFrame: Change from baseline, 6 weeks Level the self-esteem at 12 weeks
measure: Dimensions the quality of Life from cancer
timeFrame: Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks
measure: Dimensions the quality of Life from breast cancer
timeFrame: Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks
measure: Level the pain
timeFrame: Change from baseline, 6 weeks Level the pain at 12 weeks
measure: Eating habits
timeFrame: Change from baseline, 6 weeks Eating habits at 12 weeks
Other outcomes:
Locations:
city: São Luís
country: Brazil
facility: Andréa Dias Reis
state: Maranhão
Study officials:
affiliation: Federal University of Maranhão
name: Andréa D Reis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghosn B, Benisi-Kohansal S, Ebrahimpour-Koujan S, Azadbakht L, Esmaillzadeh A. Association between healthy lifestyle score and breast cancer. Nutr J. 2020 Jan 14;19(1):4. doi: 10.1186/s12937-020-0520-9.
citation: Gao Z, Ryu S, Chen Y. Effects of Tai Chi App and Facebook health education programs on breast cancer survivors' stress and quality of life in the Era of pandemic. Complement Ther Clin Pract. 2022 Aug;48:101621. doi: 10.1016/j.ctcp.2022.101621. Epub 2022 Jun 16.
citation: Fridriksdottir N, Gunnarsdottir S, Zoega S, Ingadottir B, Hafsteinsdottir EJG. Effects of web-based interventions on cancer patients' symptoms: review of randomized trials. Support Care Cancer. 2018 Feb;26(2):337-351. doi: 10.1007/s00520-017-3882-6. Epub 2017 Sep 18.
citation: Hardcastle SJ, Maxwell-Smith C, Kamarova S, Lamb S, Millar L, Cohen PA. Factors influencing non-participation in an exercise program and attitudes towards physical activity amongst cancer survivors. Support Care Cancer. 2018 Apr;26(4):1289-1295. doi: 10.1007/s00520-017-3952-9. Epub 2017 Oct 31.