The Influence of Physical Activity on Physical and Emotional Health Indicators in Women Who Have Survived Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer Survivor
- Sponsor
- Federal University of Bahia
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Quality of life
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Introduction: Cancer remains a leading cause of death globally, with breast cancer being the most common type among women worldwide. The risk of breast cancer is influenced by genetic and lifestyle factors. Healthy dietary habits, regular physical activity, and maintaining a healthy body weight not only reduce the risk of primary neoplastic lesions but also help prevent recurrence. Objective: To assess the impact of educational strategies on behavioral changes, health, and quality of life in women following breast cancer treatment. Methods: This randomized intervention study included 32 participants divided into three groups: remote exercise intervention, e-book guidance, and control. The 12-week intervention involved three weekly sessions with a physical educator and a nutritional consultation. Primary outcomes focused on quality of life, sleep quality, and perceived stress, while secondary outcomes assessed clinical data on biochemical markers, blood pressure, morphofunctional parameters (strength, flexibility, cardiorespiratory capacity), and comorbidities. Women who completed initial breast cancer treatment (surgery, chemotherapy, radiotherapy) and voluntarily participated in the lifestyle program were included in the study. Participants were recruited through invitation letters sent to eligible women from an oncology reference clinic in Salvador. At baseline, standardized questionnaires collected sociodemographic data (age, origin, race, education level), clinical information, and lifestyle habits (smoking, alcohol consumption). Specific questionnaires gathered details on physical activity level (IPAQ), quality of life (SF-36), perceived stress (PSS), sleep quality (PSQI), and morphofunctional assessments (strength tests, BMI, and waist circumference). The questionnaires were administered in person, along with assessments of anthropometric data (BMI, waist circumference), upper and lower limb strength (dynamometry and chair-stand test), cardiorespiratory fitness test, standardized questionnaires, and a 24-hour dietary recall (R24h). Additionally, protocols such as IPAQ, SF-36, PSS, PSQI, and dietary quality questionnaires were used. Intervention: The study intervention focused on developing knowledge about healthy lifestyle habits, emphasizing the benefits of dietary and exercise changes, and promoting motivation and self-confidence to sustain health-oriented behavioral changes. This intervention is anticipated to promote improvements in participant health and lifestyle, impacting their physical health and quality of life.
Detailed Description
Ethical Considerations To meet ethical standards, this study, commenced after approval by the Ethics and Research Committee of the School of Nutrition at the Federal University of Bahia (ENUFBA) and the participating institution. Eligible patients were invited to sign the Free and Informed Consent Form (ICF) after receiving all relevant project information, especially regarding procedures and methodology. It is noteworthy that this project has already been approved-approval numbers 3.935.544 from ENUFBA and 4.185.408 from Santo Antônio Hospital/Sister Dulce Social Works. The study was conducted in accordance with all regulatory guidelines and standards for research involving human subjects as outlined in Resolution 466/2012 of the National Health Council. Participation in the research was voluntary, and all patient information will be kept confidential. Patients who chose not to participate in the study protocol will continue to receive medical and nutritional follow-up at the clinic.
Investigators
DARIO DA SILVA MONTE NERO
Master of Science
Federal University of Bahia
Eligibility Criteria
Inclusion Criteria
- •Had completed breast cancer treatment (surgery, chemotherapy and/or radiotherapy) at least three months previously.
- •Had medical clearance to practice physical activity.
- •Were interested in voluntarily participating in the protocol.
Exclusion Criteria
- •They had locomotion or joint limitations that could prevent them from exercising.
- •Had psychiatric limitations.
- •Were pregnant or breastfeeding.
- •Had been doing guided physical activity for at least three months prior to the intervention.
- •Did not have access to appropriate technology for remote activities.
Outcomes
Primary Outcomes
Quality of life
Time Frame: 12 weeks
Used a questionnaire (Short Form Health Survey, SF-36), internationally recognized, self-administered questionnaire containing 36 items covering eight physical and mental health domains, and two physical and mental summary scales. The raw scores are recorded, then aggregated and transformed into a scale from 0 to 100, and higher scores indicate better health.
Perceived Stress Scale (PSS-10)
Time Frame: 12 weeks
Perceived Stress Scale (PSS-10) The Perceived Stress Scale (PSS-10) was developed in order to identify life experiences linked to emotion, characterizing the level of stress in the last 30 days, and can be used in any individual over the age of 15. Validated in Brazil, this scale consists of 10 multiple-choice items referring to the frequency with which individuals perceive certain situations, with answer options ranging from 1 to 5 (1 = never; 2 = almost never; 3 = sometimes; 4 = almost always and 5 = always). Questions 4, 5, 7 and 8 are scored inverted, as follows: 1=4, 2=3, 3=2, 4=1, 5=0 and the others are added directly in a progressive manner. The total of the scale is the sum of the scores of the 10 questions. The total score can vary from 0 to 40 and the higher the score, the greater the perceived stress. For the purposes of analysis in this study, the stress scale can be analyzed as a qualitative variable, with the total score.
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 12 weeks
Sleep quality This project will use the Pittsburgh Sleep Quality Index (PSQI), an instrument validated and culturally adapted for the Brazilian population, which subjectively assesses the quality of the sleep pattern, in its general aspects, for the last month in adult individuals. The PSQI instrument has 10 questions, of which questions 1 to 4 are open-ended and questions 5 to 10 are semi-open-ended, all of which have space to record comments if necessary. The questions are divided into 7 components: 1) subjective quality, 2) latency, 3) duration, 4) habitual sleep efficiency, 5) sleep disturbances, 6) use of sleep medication, 7) daytime sleepiness and daytime disturbances. Each component is scored from 0 to 3, giving a minimum value of 0 and a maximum of 21 points. The scores are classified as follows: 0-5 as good sleep quality, 6-10 as poor quality and 11-21 as sleep disturbance.
Level of Physical Activity (NAF)
Time Frame: 12 weeks
Level of Physical Activity (NAF) The level of physical activity was identified using the International Physical Activity Questionnaire (IPAQ), short version, made up of seven open questions. This instrument made it possible to measure the amount of time spent on moderate to vigorous physical activity each week, covering different daily contexts such as domestic activities, leisure, work, commuting and periods of inactivity. The IPAQ showed good stability and accuracy, making it suitable for epidemiological studies in various age groups, including young people, adults and the elderly. For analysis purposes, individuals who performed less than 150 minutes of physical activity per week were classified as inactive and those who performed more than 150 minutes as active, according to the IPAQ guidelines.
Secondary Outcomes
- Upper limb strength test Palmar pressure(12 weeks)
- Lower limb strength test (sit and stand).(12 weeks)
- The Wells Bench Flexibility Test(12 weeks)
- Cardiorespiratory Capacity Test (6 Minute Walk)(12 weeks)
- Anthropometric measurements: Weight(12 weeks)
- Anthropometric measurements: Height(12 weeks)
- Anthropometric measurements: Waist circumference (WC)(12 weeks)
- ESQUADA (Diet Quality Scale)(12 weeks)