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Health Education for Women With Breast Cancer

Primary Purpose

Breast Cancer Female

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Health Education
Sponsored by
Federal University of Maranhao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer Female focused on measuring Breast Neoplasms, Sedentary Behavior, Lifestyle, Health Education

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Andréa Dias ReisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Health Education

usual care

Arm Description

Group of women being treated for breast cancer

Group of women who will remain in usual care

Outcomes

Primary Outcome Measures

Life habits
Lifestyle will be evaluated by Individual Lifestyle Profile Questionnaire

Secondary Outcome Measures

Body composition (lean mass, fat mass)
Body Composition will be evaluated by Sanny Tetrapolar Bioimpedance (Model 1011)
Sitting time
Sedentary behavior will be evaluated by triaxial accelerometers motion sensor Actigraph GT3X model
Time and level the physical activity
Physical activity level will be evaluated by triaxial accelerometers motion sensor Actigraph, GT3X model.
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)
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)
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)
Level the pain
Pain will be evaluated by Brief Pain Inventory (score 1 to 10 - higher score is worse outcome)
Eating habits
Eating behavior will be evaluated by (score 1 to 4 - higher score is better outcome)

Full Information

First Posted
March 22, 2023
Last Updated
May 15, 2023
Sponsor
Federal University of Maranhao
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1. Study Identification

Unique Protocol Identification Number
NCT05873296
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Maranhao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
Breast Neoplasms, Sedentary Behavior, Lifestyle, Health Education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health Education
Arm Type
Experimental
Arm Description
Group of women being treated for breast cancer
Arm Title
usual care
Arm Type
No Intervention
Arm Description
Group of women who will remain in usual care
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
The intervention will last for 12 weeks, a health education program (face-to-face meetings and information in social networks).
Primary Outcome Measure Information:
Title
Life habits
Description
Lifestyle will be evaluated by Individual Lifestyle Profile Questionnaire
Time Frame
Change from baseline, 6 weeks Life habits at 12 weeks
Secondary Outcome Measure Information:
Title
Body composition (lean mass, fat mass)
Description
Body Composition will be evaluated by Sanny Tetrapolar Bioimpedance (Model 1011)
Time Frame
Change from baseline, 6 weeks Body composition at 12 weeks
Title
Sitting time
Description
Sedentary behavior will be evaluated by triaxial accelerometers motion sensor Actigraph GT3X model
Time Frame
Change from baseline, 6 weeks Sitting time at 12 weeks
Title
Time and level the physical activity
Description
Physical activity level will be evaluated by triaxial accelerometers motion sensor Actigraph, GT3X model.
Time Frame
Change from baseline, 6 weeks Time and level the physical activity at 12 weeks
Title
Level the self-esteem
Description
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 Frame
Change from baseline, 6 weeks Level the self-esteem at 12 weeks
Title
Dimensions the quality of Life from cancer
Description
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)
Time Frame
Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks
Title
Dimensions the quality of Life from breast cancer
Description
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)
Time Frame
Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks
Title
Level the pain
Description
Pain will be evaluated by Brief Pain Inventory (score 1 to 10 - higher score is worse outcome)
Time Frame
Change from baseline, 6 weeks Level the pain at 12 weeks
Title
Eating habits
Description
Eating behavior will be evaluated by (score 1 to 4 - higher score is better outcome)
Time Frame
Change from baseline, 6 weeks Eating habits at 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andréa D Reis
Phone
+55 98987220570
Email
andrea.dr@ufma.br
First Name & Middle Initial & Last Name or Official Title & Degree
Letícia C Aguiar
Phone
+55 98991258879
Email
leticia.campos@discente.ufma.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andréa D Reis
Organizational Affiliation
Federal University of Maranhão
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andréa Dias Reis
City
São Luís
State/Province
Maranhão
ZIP/Postal Code
65058185
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andréa D Reis, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31937325
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.
Results Reference
background
PubMed Identifier
35738114
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.
Results Reference
background
PubMed Identifier
28921391
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.
Results Reference
background
PubMed Identifier
29090387
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.
Results Reference
background
Links:
URL
https://www.cancer.org/cancer/breast-cancer/treatment.html
Description
AMERICAN CANCER SOCIETY
URL
https://www.who.int/pt/news/item/03-02-2021-breast-cancer-now-most-common-form-of-cancer-who-taking-action
Description
World Health Organization

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Health Education for Women With Breast Cancer

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