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Clinical Trials/NCT05057598
NCT05057598RecruitingNot Applicable

DianaWeb: Before and After Study Online Based Participatory Research to Test Whether Lifestyle and Diet Are Able to Reduce the Incidence of Recurrences (Local, Remote) or Secondary Cancers, Improve Prognosis and Survival of Breast Cancer

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano1 site in 1 country50,000 target enrollmentStarted: June 21, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
50,000
Locations
1
Primary Endpoint
Decrease the insulin resistance index (HOMA index)

Study Overview

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.

Detailed Description

The investigators intend to carry out a participatory research on the influence of lifestyle after cancer diagnosis on the risk of recurrence. The investigators intend wake available to breast cancer survivors' evidence-based information on the effects of lifestyle on quality of life and prognosis and to invite and help them to adopt potentially preventive sustainable lifestyle changes. To improve the prognosis, the investigators will base the recommendations on the European Code Against Cancer 2014 (ECAC), on the World Cancer Research Fund 2018 (AICR/WCRF), Continuous Update Project (CUP) 2014 specific recommendations to breast cancer survivors, and on Mediterranean diet. As for the prevention of side effect of treatments there is no definitive evidence, but the daily exercise seems for reducing menopausal symptoms and osteoporosis, while regular consumption of food with diuretic effect for arthralgia due to aromatase inhibitors. The investigators are aware that the path for creating data to implementing evidence in routine practice is long and arduous. The investigators are confident, however, that engaging participants in the research process will enable many of participants to implement evidence-based practices in everyday life. The investigators, together with computer programmers, have developed an interactive website to build a large cohort of breast cancer survivors and to follow up participants about the impact of lifestyles and nutrition on recurrences, incidence of second breast cancer, metastasis, other cancers and other chronic diseases. The investigators will also monitor the prevalence of side effects of treatments (the investigators will focus on menopausal symptoms, arthralgia, osteoporosis and bone fractures). Observational epidemiological studies have consistently shown that sedentary lifestyle, overweight, metabolic syndrome, chronic inflammatory status, high glycemia and insulinemia, and a few specific dietary factors (low fibre and high saturated fat) are associated with poor breast cancer specific survival. There is ample room for reducing recurrences and cancer progression through lifestyles and nutrition. All these factors are clearly modifiable, but there is uncertainty, however, over whether voluntarily changing these factors after breast cancer diagnosis improve prognosis. In a 5 years' time the study after recruitment, the investigators are expected to confirm the prognostic role of this factors.

In Italy every year over 50.000 women develop breast cancer. The country is fairly well equipped with excellent breast cancer units and in the second decade of the twenty-first century 5-year breast cancer net survival reached 88%, a performance similar to the best European countries. Over 750.000 Italian women live with a previous diagnosis of breast cancer. Many of them with some form of cancer treatment and suffer from feeling left alone, fear of cancer recurrence and not receiving enough information and guidance after treatment: on prognosis, side effects of treatment, lifestyle strategies to help preventing side effects of treatments, recurrences and new primaries. Many survivors integrate adjuvant treatment with complementary treatments without scientific proof of efficacy, even with folk treatments that might increase the risk of recurrences.

Young women undergoing adjuvant breast cancer therapy experience a heavy impairment in important quality of life domains (anxiety, depression, loss or sexual desire, weight gain). The great majority of women under hormonal treatment experience an increase in the prevalence of menopausal symptoms and have sexual dysfunction that is distressing and difficult to resolve. In postmenopausal survivors with aromatase inhibitor-induced arthralgia the intensity of pain is associated with fear of recurrence.

Investigating whether lifestyle factors affect breast cancer patients' survival is a relatively new area of research, but there is growing evidence that the effect of modifiable anthropometric and metabolic factors may be of the same order of magnitude than the effect of the usual clinic-pathological risk factors.

Epidemiological evidence, even if based only on observational studies, suggest that lifestyle modification, including physical exercise and dietary habits, might have a strong impact on breast cancer patients overall and specific survival.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

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).

Intervention: Community-based participatory research on diet and lifestyle (Other)

Outcomes

Primary Outcomes

Decrease the insulin resistance index (HOMA index)

Time Frame: baseline, 1 year, 5 years, 10 years

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).

Decrease incidence of relapses

Time Frame: Baseline, 10 years

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.

Decrease incidence of Metabolic Syndrome parameters

Time Frame: baseline, 1 year, 5 years, 10 years

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).

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

Time Frame: baseline, 1 year, 5 years, 10 years

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).

Increase rate of survival

Time Frame: Baseline, 10 years

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.

Decrease incidence of metastasis

Time Frame: Baseline, 10 years

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.

Secondary Outcomes

  • 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)
  • 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 diet score (MDS)(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 to the "European Organisation for Research and Treatment of Cancer, Quality of Life questionnaire-breast cancer 45 (QLQ-BR45)" during therapy(baseline, 1 year, 3 years, 5 years, 10 years)

Investigators

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anna Villarini

Biologist, Nutritionist, PhD and Senior Research

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Sites (1)

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