Health Education for Women With Breast Cancer

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873296
• Other study ID #: UFMA
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Federal University of Maranhao
• Contact: Andréa D Reis
• Phone: +55 98987220570
• Email: andrea.dr[@]ufma.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Brazil	Andréa Dias Reis	São Luís	Maranhão

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Maranhao

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Life habits	Lifestyle will be evaluated by Individual Lifestyle Profile Questionnaire	Change from baseline, 6 weeks Life habits at 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   AMERICAN CANCER SOCIETY
•   World Health Organization