NCT05873296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

March 22, 2023

Last Update Submit

December 3, 2025

Conditions

Keywords

Breast NeoplasmsSedentary BehaviorLifestyleHealth Education

Outcome Measures

Primary Outcomes (1)

  • Life habits

    Lifestyle will be evaluated by Individual Lifestyle Profile Questionnaire (score 0 to 3 - higher score is better)

    Change from baseline, 6 weeks Life habits at 12 weeks

Secondary Outcomes (8)

  • Body composition (lean mass, fat mass)

    Change from baseline, 6 weeks Body composition at 12 weeks

  • Sitting time

    Change from baseline, 6 weeks Sitting time at 12 weeks

  • Time and level the physical activity

    Change from baseline, 6 weeks Time and level the physical activity at 12 weeks

  • Level the self-esteem

    Change from baseline, 6 weeks Level the self-esteem at 12 weeks

  • Dimensions the quality of Life from cancer

    Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

Health Education

EXPERIMENTAL

Group of women being treated for breast cancer

Behavioral: Health Education

usual care

NO INTERVENTION

Group of women who will remain in usual care

Interventions

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

Health Education

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andréa Dias Reis

São Luís, Maranhão, 65058185, Brazil

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsSedentary BehaviorHealth Education

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Andréa D Reis

    Federal University of Maranhão

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2023

First Posted

May 24, 2023

Study Start

July 1, 2023

Primary Completion

November 30, 2024

Study Completion

December 30, 2024

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations