An interventional study of MoviS Training in Breast Cancer Survivors, sponsored by University of Urbino "Carlo Bo". Active, not recruiting at 2 sites in Italy. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-09.
Sponsored by University of Urbino "Carlo Bo" · Not applicable, Interventional, and Prevention
MoviS is a randomized controlled trial on the effect of aerobic exercise training on quality of life (QoL) among breast cancer (BC) survivors.
Patients randomized to the intervention arm will receive lifestyle recommendations (nutrition and exercise) and will undergo the MoviS Training program, whereas control arm patients will receive lifestyle recommendations. The MoviS Training program consists of 3 months, 3 times per week, aerobic exercise, which will be supervised both directly (2 days each week) and remotely (1 day each week). Exercise intensity (40% to 70% of heart rate reserve) and duration (20 to 60 mins) will be gradually increased throughout the training period. Both arms will receive counseling on psychological well-being.
The primary outcome is the improvement of QoL. The secondary outcome is the improvement of the health-related parameters.
Study variables will be sampled and compared between and within groups at the baseline, after the 3 month intervention period, ad interim in the short term (6 months) and long term (12 and 24 months).
BACKGROUND BC is the most common invasive cancer in women and evidence has shown that exercise can significantly improve the outcomes of BC survivors. MoviS (Movement and Health Beyond Care) is a randomized controlled trial that aims to evaluate the potential health benefits of exercise and proper nutritional habits.
Aim The present research study aims to assess the efficacy of aerobic exercise training on the QoL of high-risk BC survivors and the improvement of health-related factors.
Methods BC patients (sample size n=172), age 30-70 years, non-metastatic, stage 0-III, non-physically active, 6-12 months post-surgery, and post chemo- or radio-therapy, with a high risk of recurrence defined by one or more of the following criteria: BMI ≥ 25, diagnosis of metabolic syndrome, increased level of blood testosterone and insulin will be randomly allocated to the interventional arm (lifestyle recommendations and MoviS Training) or control arm (lifestyle recommendations). The MoviS Training consists of 3 months of aerobic exercise training (2 d/week of directly supervised and 1 d/week of remotely supervised exercise) with a progressive increase in exercise intensity (40-70% of heart rate reserve) and duration (20-60 min). Both arms will receive counseling on healthy lifestyle habits (nutrition and exercise) based on the World Cancer Research Fund (WCRF) 2018 guidelines through the DIANA-Web platform. All patients will also undergo psychological well-being counseling, which comprises evaluation for anxiety and depression.
The primary outcome is the improvement of the QoL assessed by the European Organization for Research and Treatment of Cancer QoL (EORTC QLQ-C30) questionnaire.
The secondary outcome is the improvement of health-related parameters such as: fatigue; anthropometric measurements and body composition; cardiac function indexes and heart rate variability; functional parameters (cardiorespiratory fitness, muscle flexibility and strength, coordination and posture variability, upper limb muscle viscoelastic characteristics); psychological well-being; metabolic, hormonal and inflammatory risk factors; gut microbiota; osteoporosis level; recurrences. Diet habits, physical activity level, pharmacological treatments and comorbidity will be recorded as confounding factors and covariates.
The hypothesis is that supervised exercise may improve QoL and health-related factors of BC survivors with a high risk of recurrence.
Data will be collected at baseline and after the 3 month intervention period, ad interim in the short term (6 months) and long term (12 and 24 months).
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 172 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Urbino "Carlo Bo" is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Supervised exercise program: MoviS Training. Lifestyle (nutrition and exercise) counseling based on WCRF 2018 recommendations; psychological well-being counseling which comprises evaluation for anxiety and depression.
Behavioral: MoviS Training
Lifestyle (nutrition and exercise) counseling based on WCRF 2018 recommendations; psychological well-being counseling which comprises evaluation for anxiety and depression.
Patients will undergo a supervised exercise program consisting of 3 months of aerobic exercise training (2 d/week of directly supervised exercise and 1 d/week of remotely supervised exercise) with a progressive increase in exercise intensity (40-70% of heart rate reserve) and duration (20-60 min).
Quality of life assessed by questionnaire
Change in quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores ranging from 0 to 100; higher scores indicate better quality of life.
Time frame: Baseline - after 3, 6, 12, 24 months
Fatigue
Change in fatigue perception assessed by brief fatigue inventory (BFI) questionnaire. The score of the questionnaire ranges from 0 to 90. A higher score means more severe fatigue.
Time frame: Baseline - after 3, 6, 12, 24 months
Anthropometry
Change body mass index (BMI) expressed as body mass (kg) / height2 (m2).
Time frame: Baseline - after 3, 6, 12, 24 months
Body composition
Change fat mass (%) assessed by bioelectrical impedance analysis.
Time frame: Baseline - after 3, 6, 12, 24 months
Cardiac function indexes
Change in the global longitudinal strain (%) assessed by echocardiography.
Time frame: Baseline - after 3, 6, 12, 24 months
Heart rate variability
Change in heart rate variability assessed by 24-Holter monitoring.
Time frame: Baseline - after 3 months
Cardiorespiratory fitness
Change in cardiorespiratory fitness assessed by estimated maximal oxygen uptake (mL/min/kg).
Time frame: Baseline - after 3, 6, 12, 24 months
Flexibility
Change in muscle flexibility assessed by sit \& reach test (m).
Time frame: Baseline - after 3, 6, 12, 24 months
Muscular fitness
Change strength assessed by isometric hand grip strength test (kg).
Time frame: Baseline - after 3, 6, 12, 24 months
Proprioceptive recalibration
Change assessed by stabilometry (Mean Velocity) (mm2/sec2).
Time frame: Baseline - after 6 months
Posture balance
Change assessed by stabilometry (Romberg Quotient test-European variant) (% over or under 100).
Time frame: Baseline - after 6 months
Upper limb muscles viscoelastic characteristics
Change in the muscle properties of the pectoralis major, upper trapezius, and sternoclavicular mastoid muscle assessed by a hand-held myotonometer.
Time frame: Baseline - after 3 months
Psychological well-being
Change in mood profile assessed by Profile of Mood States (POMS) questionnaire. The POMS questionnaire gives a 5-point Likert scale; a higher score indicates increased negative mood.
Time frame: Baseline - after 3, 6, 12, 24 months
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Index
Change in HOMA-IR Index calculated as HOMA-IR = (FPI × FPG)/22.5, where FPI is fasting plasma insulin concentration (mU/l) and FPG is fasting plasma glucose (mmol/L), or as HOMA-IR = (FPI × FPG)/405 if fasting plasma glucose is expressed in mg/dL.
Time frame: Baseline - after 3, 6, 12, 24 months
Insulin-like growth factor (IGF-1)
Change in IGF-1 assessed by blood samples (µg/L).
Time frame: Baseline - after 3, 6, 12, 24 months
C-reactive protein
Change in high sensitivity C-reactive protein assessed by blood samples (mg/L).
Time frame: Baseline - after 3, 6, 12, 24 months
Gut microbiota
Change in microbial diversity (species diversity %) assessed by next-generation sequencing (NGS) of the V3-V4 region of the 16S rDNA gene.
Time frame: Baseline - after 3, 6, 12, 24 months
Osteoporosis level
Change in computerized bone mineralometry assessed by T-Score (Normal: +2.5\> T-score\> -1.0; Osteopenia: -1.0\> T-score\> -2.5; Osteoporosis: T-score \<-2.5; Severe osteoporosis: T-score \<-2.5 with one or more fragility fractures).
Time frame: Baseline - after 12 and 24 months
Recurrences
Recurrences free interval defined as time from registration to time of documented recurrent disease.
Time frame: Baseline - after 3, 6, 12, 24 months
Diet habits
Change in dietary intake assessed by questionnaire (14-item Mediterranean diet adherence screener, MEDIET) through DIANAWeb platform. Higher levels (8-9, or \>10 points in the 14-item score) indicates adherence to the Mediterranean diet.
Time frame: Baseline - after 3, 6, 12, 24 months
Physical activity level
Change in physical activity level assessed by the sensewear armband activity monitor and by the international physical activity questionnaire (IPAQ). The output of both assessments expressed in metabolic equivalents (METs)-min/week.
Time frame: Baseline - after 3, 6, 12, 24 months
Started Jan 2020 (actual). Primary completion is estimated for May 2024, 52 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 52 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University of Urbino "Carlo Bo"