Clinical trial NCT06672380: The INFLUENCE of PHYSICAL ACTIVITY on the HEALTH and WELL-BEING of BREAST CANCER SURVIVORS
Official title: The Influence of Physical Activity on Physical and Emotional Health Indicators in Women Who Have Survived Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivor
Keywords: Breast cancer
Physical exercise
Physical activity
Quality of life
Perceived stress
Sleep quality
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Quality of life
timeFrame: 12 weeks
measure: Perceived Stress Scale (PSS-10)
timeFrame: 12 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12 weeks
measure: Level of Physical Activity (NAF)
timeFrame: 12 weeks
Secondary outcomes:
measure: Upper limb strength test Palmar pressure
timeFrame: 12 weeks
measure: Lower limb strength test (sit and stand).
timeFrame: 12 weeks
measure: The Wells Bench Flexibility Test
timeFrame: 12 weeks
measure: Cardiorespiratory Capacity Test (6 Minute Walk)
timeFrame: 12 weeks
measure: Anthropometric measurements: Weight
timeFrame: 12 weeks
measure: Anthropometric measurements: Height
timeFrame: 12 weeks
measure: Anthropometric measurements: Waist circumference (WC)
timeFrame: 12 weeks
measure: ESQUADA (Diet Quality Scale)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: School of Nutrition-Universidade Federal da Bahia
state: Bahia
Study officials:
affiliation: Federal University of Bahia
name: Dario SM Nero, Master
role: PRINCIPAL_INVESTIGATOR
References: