The INFLUENCE of PHYSICAL ACTIVITY on the HEALTH and WELL-BEING of BREAST CANCER SURVIVORS

NCT06672380 | Completed DMC

• 1 other identifier: 001-PAF-SBM-2024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Survivor

Keywords

Breast cancer; Physical exercise; Physical activity; Quality of life; Perceived stress; Sleep quality

Outcome Measures

Primary Outcomes (4)

• Quality of life

  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.

  12 weeks

• Perceived Stress Scale (PSS-10)

  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.

  12 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  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.

  12 weeks

• Level of Physical Activity (NAF)

  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.

  12 weeks

Secondary Outcomes (8)

• 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

Study Arms (3)

Structured and remotely guided physical exercise program for women who are breast cancer survivors

EXPERIMENTAL

Structured and remotely guided physical exercise program The participants in this group took part in a remote exercise program for 3 months, with three classes a week, each lasting 1 hour on alternate days. This group had a more active follow-up, with personalized instruction and ongoing support to improve their physical and emotional health.

Other: Remote Physical Exercise Program for Breast Cancer Survivors

Initial Consultation and Exercise Guidance via Ebook for Women Surviving Breast Cance

ACTIVE COMPARATOR

Arm 2: Initial Consultation and Exercise Guidance via Ebook The participants in this group received an initial consultation, where they were presented with health guidelines and an eBook containing information and guidance on physical exercise. After 30 days, they were given additional encouragement via text message to reinforce physical activity through the eBook, but there was no ongoing direct interaction.

Other: Initial Consultation and Exercise Guidance via Ebook for Women Surviving Breast Cance

Initial Incentive for Eating Habits in Women Surviving Breast Cancer

PLACEBO COMPARATOR

Arm 3: The control group only received general guidance on the importance of regular physical activity. The recommendations followed health guidelines, suggesting between 150 and 300 minutes of moderate-intensity physical activity per week.

Other: Initial Incentive for Eating Habits in Women Surviving Breast Cancer

Interventions

Remote Physical Exercise Program for Breast Cancer Survivors OTHER

Structured and remotely guided physical exercise program The participants in the intervention group took part in a remote physical exercise program for 12 weeks. The telepresence sessions, conducted three times a week via Google Meet®, lasted 60 minutes and consisted of three phases: warm-up (10 minutes), multi-joint functional exercises (40 minutes) and stretching (10 minutes). The exercises were progressively intensified over the weeks, using the Borg scale to monitor effort. The intensity was adjusted in three cycles: in the first 4 weeks (60 seconds of exercise/90 seconds of rest), in weeks 5 to 8 (75 seconds of exercise/60 seconds of rest) and in weeks 9 to 12 (90 seconds of exercise/30 seconds of rest).

Also known as: Online Fitness Training for Female Cancer Survivors, Distance Physical Activity Program for Breast Cancer Survivors, Virtual Exercise Intervention for Women Recovering from Cancer, Remote Exercise Classes for Breast Cancer Survivors, Remote Fitness Program for Women with Breast Cancer, Structured and remotely guided physical exercise program

Structured and remotely guided physical exercise program for women who are breast cancer survivors

Initial Consultation and Exercise Guidance via Ebook for Women Surviving Breast Cance OTHER

Participants in the Ebook group received an illustrated manual containing detailed guidelines for practicing simple physical exercises at home, using only their body weight. The manual suggested a frequency of 3 to 5 times a week, with 30 to 60 minutes of activities such as stretching, squats and exercises for the upper and lower limbs. The participants were encouraged to follow these guidelines and, 30 days after receiving the ebook, an additional stimulus was sent by text message, reinforcing the importance of following the protocol.

Also known as: Initial Consultation and Exercise Guidance via Ebook

Initial Consultation and Exercise Guidance via Ebook for Women Surviving Breast Cance

Initial Incentive for Eating Habits in Women Surviving Breast Cancer OTHER

The control group only received general guidance on the importance of regular physical activity. The recommendations followed health guidelines, suggesting between 150 and 300 minutes of moderate-intensity physical activity per week.

Initial Incentive for Eating Habits in Women Surviving Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Bahia: lead

Study Sites (1)

School of Nutrition-Universidade Federal da Bahia

Salvador, Estado de Bahia, 40.110-907, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Dario SM Nero, Master

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: September 15, 2023
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Individual participant data will be available from \[10/11/2024\], and will remain accessible until \[10/12/2025\]. During this period, interested researchers will be able to request access to the data and supporting information, which includes data on sleep quality, morphofunctional aspects, perceived stress and other relevant data collected during the study.
• Access Criteria: Academic researchers and health professionals who are involved in studies on breast cancer, physical activity or quality of life. Research institutions and universities that have approved research protocols. What they can access: Authorized researchers will be able to access: Participants' demographic data (age, ethnicity, marital status, education and income). Information on health and clinical conditions (diagnosis, treatment, comorbidities). Results related to quality of life, sleep quality, perceived stress and morphofunctional aspects (muscle strength, VO2max, flexibility). How to access: Those interested should: Send a formal request by e-mail to \[your e-mail or contact address\]. Include a description of the research project and how the data will be used. Provide ethical approval, if necessary. Wait for the request to be analyzed and for a confidentiality agreement to be signed, guaranteeing that the data will be used exclusively for research purposes.

Locations

BR (1)