NCT05057598

Brief Summary

DianaWeb is a community-based participatory research (CBPR) offered to Italian breast cancer patients. The aim of the study is the evaluation of effectiveness of a lifestyle and nutrition intervention to improve the prognosis. DianaWeb study utilizes an interactive website - http://www.dianaweb.org/ - to monitor patient life-style, and to obtain clinical, pathological and anthropometric data (height, body weight, waist circumference and blood pressure). Detailed instructions were provided for measuring at home. The website contains theoretical and practical advice to encourage women to follow healthy lifestyles and nutrition, and the indications emerging from research for women diagnosed with breast cancer. DianaWeb study intends to recruit 50.000 women with breast cancer diagnosis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
33mo left

Started Jun 2016

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jun 2016Dec 2028

Study Start

First participant enrolled

June 21, 2016

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

7.5 years

First QC Date

August 28, 2021

Last Update Submit

September 15, 2021

Conditions

Breast Cancer

Keywords

Breast cancerDietPhysical activityPrognosis

Outcome Measures

Primary Outcomes (6)

  • Increase rate of survival

    Evaluate the change in rate of survival in relation to adherence to correct lifestyles and health nutrition (ECAC, AICR/WCRF recommendations and Mediterranean diet) through the information provided by the family members, the physician and the cancer registry.

    Baseline, 10 years

  • Decrease incidence of relapses

    Evaluate the change about incidence of relapses in relation to adherence to correct lifestyles and health nutrition (ECAC, AICR/WCRF recommendations and Mediterranean diet) through the information provided by the patient and the physician.

    Baseline, 10 years

  • Decrease incidence of metastasis

    Evaluate the change about incidence of metastasis in relation to adherence to correct lifestyles and health nutrition (ECAC, AICR/WCRF recommendations and Mediterranean diet) through the information provided by the patient and the physician.

    Baseline, 10 years

  • Decrease incidence of Metabolic Syndrome parameters

    Evaluate the change about incidence of Metabolic Syndrome parameters in relation to adherence to correct lifestyles and health nutrition (ECAC, AICR/WCRF recommendations and Mediterranean diet).

    baseline, 1 year, 5 years, 10 years

  • Decrease blood level on C-reactive protein (chronic inflammation marker)

    Evaluate the change of the blood level on C-reactive protein, in relation to adherence to correct lifestyles and health nutrition (ECAC, AICR/WCRF recommendations and Mediterranean diet).

    baseline, 1 year, 5 years, 10 years

  • Decrease the insulin resistance index (HOMA index)

    Evaluate the change in the insulin resistance index, in relation to adherence to correct lifestyles and health nutrition (ECAC, AICR/WCRF recommendations and Mediterranean diet).

    baseline, 1 year, 5 years, 10 years

Secondary Outcomes (6)

  • Increase in the score of adherence to the Mediterranean diet score (MDS)

    baseline, 1 year, 3 years, 5 years, 10 years

  • Increase in the score of adherence to the Italian Mediterranean index (IMI)

    baseline, 1 year, 3 years, 5 years, 10 years

  • Increase in the score of adherence to the Mediterranean Adequancy index (MAI)

    baseline, 1 year, 3 years, 5 years, 10 years

  • Increase in the score of adherence to the AICR/WCRF recommendations to the 2018 WCRF/AICR News Score

    baseline, 1 year, 3 years, 5 years, 10 years

  • Increase in the score to the "European Organisation for Research and Treatment of Cancer, Quality of Life questionnaire-core 30 (Version 3.0)" after breast cancer diagnosis

    baseline, 1 year, 3 years, 5 years, 10 years

  • +1 more secondary outcomes

Study Arms (1)

Intervention group on diet and lifestyles

EXPERIMENTAL

The arm consists to provide survivors with evidence-based recommendations and to promote improved nutrition and physical activity through videos and lectures available on the website (theoretical lectures on preventive strategies, and practical videos on cooking techniques and specific physical exercises).

Other: Community-based participatory research on diet and lifestyle

Interventions

Community-based participatory research on diet and lifestyleOTHER

The intervention use a web site that contains a section to exchange information on recipes and on strategy to comply with the recommendations, and an agenda to inform on meetings, conferences, kitchen classes, walking groups, organised by the participant themselves. The investigators are developed specific recommendations for women with different characteristics. The investigators intend to improve the specificity of information with short questionnaires on portion size of relevant items using photographs or usual container in the kitchen and develop a health application for smartphone to facilitated a more efficient and timely exchange on information. The participants will receive a free phone number for emergencies, active 2 hours a day for 5 days a week.

Intervention group on diet and lifestyles

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with breast cancer diagnosis
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with breast cancer diagnosis
  • Women with breast cancer relapses
  • Women with breast cancer metastases
  • Women with breast cancer diagnosis even if many years have elapsed since the first diagnosis
  • Women with breast cancer diagnosis and other tumors diagnosis
  • Women with breast cancer diagnosis and other pathologists that impair cognitive abilities

You may not qualify if:

  • Women with breast cancer diagnosis and clinical diagnosis of Alzheimer's Disease
  • Women with breast cancer diagnosis and clinical diagnosis of dementia
  • Women with breast cancer diagnosis unable to use personal computer and smart phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, MI, 20133, Italy

RECRUITING

Related Publications (5)

  • Natalucci V, Marini CF, Flori M, Pietropaolo F, Lucertini F, Annibalini G, Vallorani L, Sisti D, Saltarelli R, Villarini A, Monaldi S, Barocci S, Catalano V, Rocchi MBL, Benelli P, Stocchi V, Barbieri E, Emili R. Effects of a Home-Based Lifestyle Intervention Program on Cardiometabolic Health in Breast Cancer Survivors during the COVID-19 Lockdown. J Clin Med. 2021 Jun 17;10(12):2678. doi: 10.3390/jcm10122678.

    PMID: 34204528RESULT

  • Natalucci V, Villarini M, Emili R, Acito M, Vallorani L, Barbieri E, Villarini A. Special Attention to Physical Activity in Breast Cancer Patients during the First Wave of COVID-19 Pandemic in Italy: The DianaWeb Cohort. J Pers Med. 2021 May 6;11(5):381. doi: 10.3390/jpm11050381.

    PMID: 34066580RESULT

  • Gianfredi V, Nucci D, Balzarini M, Acito M, Moretti M, Villarini A, Villarini M. E-Coaching: the DianaWeb study to prevent breast cancer recurrences. Clin Ter. 2020 Jan-Feb;170(1):e59-e65. doi: 10.7417/CT.2020.2190.

    PMID: 31850486RESULT

  • Villarini M, Acito M, Gianfredi V, Berrino F, Gargano G, Somaini M, Nucci D, Moretti M, Villarini A. Validation of Self-Reported Anthropometric Measures and Body Mass Index in a Subcohort of the DianaWeb Population Study. Clin Breast Cancer. 2019 Aug;19(4):e511-e518. doi: 10.1016/j.clbc.2019.04.008. Epub 2019 Apr 18.

    PMID: 31182401RESULT

  • Villarini M, Lanari C, Nucci D, Gianfredi V, Marzulli T, Berrino F, Borgo A, Bruno E, Gargano G, Moretti M, Villarini A. Community-based participatory research to improve life quality and clinical outcomes of patients with breast cancer (DianaWeb in Umbria pilot study). BMJ Open. 2016 Jun 1;6(6):e009707. doi: 10.1136/bmjopen-2015-009707.

    PMID: 27251681RESULT

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Officials

  • ANNA VILLARINI, PhD

    Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ANNA VILLARINI, PhD

CONTACT

+390223903552anna.villarini@istitutotumori.mi.it

MILENA VILLARINI, Graduate

CONTACT

+390755857419milena.villarini@unipg.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Before and after study online based on community-based participatory research (CBPR): CBPR approach which has been defined as 'a process that involves community members or recipients of interventions in all phases of the research process'. Over the past two decades, there has been an increasing presence of community-based research and participatory methods in health research, and involving patients at various stages of the research process has been shown to improve the ethical nature of research and the appropriateness of methods.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Biologist, Nutritionist, PhD and Senior Research

Study Record Dates

First Submitted

August 28, 2021

First Posted

September 27, 2021

Study Start

June 21, 2016

Primary Completion

December 31, 2023

Study Completion (Estimated)

December 31, 2028

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

The study protocol, dataset, statistical analysis plan, informed consent form and clinical study report were discussed through meetings held with all the collaborating centers. The individual participant data (IPD) were delivered to the coordinators of the individual centers in coded anonymous.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The data will be become available from baseline up to 10 years after study the end of recruitment for all coordinators of collaborating centers
Access Criteria
The data are available on the National Cancer Institute of MILANO (Foundation-Institute of Hospitalization and Scientific Care), network managed

Locations

IT(1)