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Impact of Lifestyle Modifications on Optimal Metabolism and Quality of Life in Women Treated for Breast Cancer – The Blue Flower Project

Impact of Lifestyle on the Physical and Metabolic Health and Quality of Life of Women Treated for Breast Cancer: The Blue Flower Project

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7sk3zsn
Enrollment
Unknown
Registered
2025-11-18
Start date
2024-06-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Interventions

This is an uncontrolled, single-center clinical trial with a follow-up period of 24 weeks. The study population consists of women treated for breast cancer and volunteers residing in Rio Claro, São Pa
values above 88 cm are classified as increased. Bioelectrical impedance analysis (BIA) is used to assess body composition (InBody 770, Korea). Quality of Life, Sleep, Mindfulness/Attentiveness, and St
Sleep using the Epworth Sleepiness Scale
Attentiveness using the Mindful Attention Awareness Scale (MAAS)
and Stress using the Perceived Stress Scale. During the 24-week intervention, the group participates in structured group classes on healthy nutrition conducted by nutritionists and the multidisciplina

Sponsors

Departamento de Ginecologia e Obstetrícia
Lead Sponsor
Departamento de Ginecologia e Obstetrícia
Collaborator

Eligibility

Sex/Gender
Female
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: Women, aged between 45 and 75 years, with a histological diagnosis of breast cancer who had undergone sentinel axillary lymph node biopsy or axillary lymphadenectomy; who had completed cancer treatment (chemotherapy and/or radiotherapy), except for hormone therapy; clinical stage I, II, or III; and the ability to understand and consent to participate in the study.

Exclusion criteria

Exclusion criteria: Women with stage IV and/or metastatic disease; alcohol or drug users; clinical lymphedema of the upper limb; athletes; neurological, musculoskeletal, or other conditions limiting participation in a regular physical exercise program; or carriers of a cardiac pacemaker

Design outcomes

Primary

MeasureTime frame
An improvement in quality of life is expected, as assessed by the DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire and the EORTC QLQ-C30 (30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire)

Secondary

MeasureTime frame
Improvements are expected in body composition and anthropometric data, assessed through bioimpedance, body mass index and measurements of calf circumference;Improvements are expected in upper limb dysfunctions, such as pain, assessed using a 0–10 visual analog scale; shoulder range and speed of motion,evaluated by goniometry and a digital device called BIOBIT; handgrip strength, assessed using a handgrip dynamometer; and upper limb volumetry, evaluated by clinical circumference measurements converted into volume using the truncated cone formula;Improvements are expected in functional mobility related to fall risk, assessed by the Timed Up and Go test;Improvements are expected in perceived stress, sleep quality, and attentiveness, assessed by the Perceived Stress Scale (PSS-10), the Epworth Sleepiness Scale, and the Mindful Attention Awareness Scale;Improvements are expected in metabolic health, assessed through blood pressure measurement, waist circumference, and blood tests analyzing fasting glucose, fasting insulin, triglycerides, total cholesterol, and its fractions

Countries

Brazil

Contacts

Public ContactSamantha Karlla Rizzi

Universidade Federal de São Paulo

samantha.rizzi@unifesp.br+55(11)55764848

Outcome results

None listed

Source: REBEC (via WHO ICTRP)