Health Education for Women With Breast Cancer

May 15, 2023 updated by: Andréa Dias Reis, Federal University of Maranhao

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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%.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Maranhão
      • São Luís, Maranhão, Brazil, 65058185
        • Recruiting
        • Andréa Dias Reis
        • Contact:
          • Andréa D Reis, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health Education
Group of women being treated for breast cancer
Behavioral: Health Education
The intervention will last for 12 weeks, a health education program (face-to-face meetings and information in social networks).
No Intervention: usual care
Group of women who will remain in usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Life habits
Time Frame: Change from baseline, 6 weeks Life habits at 12 weeks
Lifestyle will be evaluated by Individual Lifestyle Profile Questionnaire
Change from baseline, 6 weeks Life habits at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition (lean mass, fat mass)
Time Frame: Change from baseline, 6 weeks Body composition at 12 weeks
Body Composition will be evaluated by Sanny Tetrapolar Bioimpedance (Model 1011)
Change from baseline, 6 weeks Body composition at 12 weeks
Sitting time
Time Frame: Change from baseline, 6 weeks Sitting time at 12 weeks
Sedentary behavior will be evaluated by triaxial accelerometers motion sensor Actigraph GT3X model
Change from baseline, 6 weeks Sitting time at 12 weeks
Time and level the physical activity
Time Frame: 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.
Change from baseline, 6 weeks Time and level the physical activity at 12 weeks
Level the self-esteem
Time Frame: 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)
Change from baseline, 6 weeks Level the self-esteem at 12 weeks
Dimensions the quality of Life from cancer
Time Frame: 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)
Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks
Dimensions the quality of Life from breast cancer
Time Frame: 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)
Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks
Level the pain
Time Frame: 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)
Change from baseline, 6 weeks Level the pain at 12 weeks
Eating habits
Time Frame: 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)
Change from baseline, 6 weeks Eating habits at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Maranhao

Investigators

  • Principal Investigator: Andréa D Reis, Federal University of Maranhão

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFMA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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