Evidence map›Paper›PMID 36814313›Full record

ArticleTrials2023

Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors.

Valentina Natalucci, Carlo Ferri Marini, Mauro De Santi, Giosuè Annibalini, Francesco Lucertini, Luciana Vallorani, Andrea Rocco Panico, Davide Sisti, Roberta Saltarelli, Sabrina Donati Zeppa and 23 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04818359 (Movement and Health Beyond Care, MoviS), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04818359 naunknown statusnot on this map

Movement and Health Beyond Care, MoviS: Nutrition and Exercise Educational Programs for Breast Cancer Survivors

TypeinterventionalSponsorUniversity of Urbino "Carlo Bo"Ran2020 to 2025Enrolled172ConditionsBreast Cancer SurvivorsArmsMoviS Training
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Cardiovascular training for fatigue in people with cancer.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

33 authors.

Valentina Natalucci *Department of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Carlo Ferri Marini *Department of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Mauro De SantiDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy. mauro.desanti@uniurb.it.ORCID http://orcid.org/0000-0003-2983-8344
Giosuè AnnibaliniDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy. giosue.annibalini@uniurb.it.
Francesco LucertiniDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Luciana ValloraniDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Andrea Rocco PanicoDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Davide SistiDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Roberta SaltarelliDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Sabrina Donati ZeppaDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Deborah AgostiniDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Marco GervasiDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Giulia BaldelliDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Eugenio GrassiDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Alessandra NartDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Massimo RossatoDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Vincenzo BiancalanaDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Giovanni PiccoliDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Piero BenelliDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Anna VillariniDepartment of Medicine and Surgery, University of Perugia, 06129, Perugia, Italy.
Matteo SomainiSchool of Specialization in Nutrition Science, University of Milano, Milan, Italy.
Vincenzo CatalanoMedical Oncology, Hospital Santa Maria della Misericordia di Urbino, 61029, Urbino, Italy.
Stefania GuarinoMedical Oncology, Hospital Santa Maria della Misericordia di Urbino, 61029, Urbino, Italy.
Alice PietrelliMedical Oncology, Hospital Santa Maria della Misericordia di Urbino, 61029, Urbino, Italy.
Silvia MonaldiMedical Oncology, Hospital Santa Maria della Misericordia di Urbino, 61029, Urbino, Italy.
Donatella SartiMedical Oncology, Hospital Santa Maria della Misericordia di Urbino, 61029, Urbino, Italy.
Simone BarocciClinical Pathology, Hospital Santa Maria della Misericordia di Urbino, 61029, Urbino, Italy.
Marco FloriCardiology, Hospital Santa Maria della Misericordia di Urbino, 61029, Urbino, Italy.
Marco Bruno Luigi RocchiDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Giorgio BrandiDepartment of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.
Vilberto StocchiDepartment of Human Sciences for the Promotion of Quality of Life, University San Raffaele, 20132, Rome, Italy.
Rita Emili *Medical Oncology, Hospital Santa Maria della Misericordia di Urbino, 61029, Urbino, Italy.
Elena Barbieri *Department of Biomolecular Sciences, University of Urbino Carlo Bo, 61029, Urbino, Italy.

Funding

Università degli Studi di Urbino Carlo Bo DR_226_2021
6 · The paper itself

Abstract

backgroundBreast cancer (BC) is the most common invasive cancer in women, and exercise can significantly improve the outcomes of BC survivors. MoviS (Movement and Health Beyond Care) is a randomized controlled trial aimed to evaluate the potential health benefits of exercise and proper nutritional habits. This study aims to assess the efficacy of aerobic exercise training in improving quality of life (QoL) and health-related factors in high-risk BC.

methodsOne hundred seventy-two BC survivor women, aged 30-70 years, non-metastatic, stage 0-III, non-physically active, 6-12 months post-surgery, and post chemo- or radiotherapy, will be recruited in this study. Women will be randomly allocated to the intervention arm (lifestyle recommendations and MoviS Training) or control arm (lifestyle recommendations). The MoviS training consists of 12 weeks of aerobic exercise training (2 days/week of supervised and 1 day/week of unsupervised 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 International (WCRF) 2018 guidelines. The primary outcome is the improvement of the QoL. The secondary outcomes are improvement of health-related parameters such as Mediterranean diet adherence, physical activity level, flexibility, muscular fitness, fatigue, cardiorespiratory fitness (estimated maximal oxygen uptake), echocardiographic parameters, heart rate variability (average of the standard deviations of all 5 min normal to normal intervals (ASDNN/5 min) and 24 h very low and low frequency), and metabolic, endocrine, and inflammatory serum biomarkers (glycemia, insulin resistance, progesterone, testosterone, and high-sensitivity C-reactive protein). DISCUSSION: This trial aims to evaluate if supervised exercise may improve QoL and health-related factors of BC survivors with a high risk of recurrence. Findings from this project could provide knowledge improvement in the field of exercise oncology through the participation of a multidisciplinary team that will provide a coordinated program of cancer care to improve healthcare quality, improve prognosis, increase survival times and QoL, and reduce the risk of BC recurrence.

trial registrationClinicalTrials.gov  NCT04818359 . Retrospectively registered on March 26, 2021.

Indexed as

Breast NeoplasmsCancer SurvivorsExerciseFemaleHumansNeoplasm Recurrence, LocalQuality of LifeRandomized Controlled Trials as TopicSurvivorsBreast cancerExerciseHealth-related parametersMediterranean dietPhysical activityPreventionQuality of life

Identifiers

PMID36814313
PMCPMC9946288

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.