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Spots Global Cancer Trial Database for Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer

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Trial Identification

Brief Title: Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer

Official Title: Evaluation of Endocrine Therapy and Patients Preferences in Early Breast Cancer - Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer.

Study ID: NCT03939156

Study Description

Brief Summary: Preference studies reveal how individuals trade-off the potential benefits, harms and inconveniences of a treatment by determining the minimum benefits they judge sufficient to make the treatment worthwhile. They are especially relevant to adjuvant therapies where individuals must weigh up modest survival benefits only realized in time by no recurrence of their cancer with side effects predominantly experienced whilst on the treatment. Previously it was reported, for example, that over 50% of women who had adjuvant chemotherapy for early breast cancer judged a 1% improvement in 5 year survival rates sufficient to make it worthwhile. Larger survival benefits were required for longer duration adjuvant hormonal therapy where over 50% of women required at least 5% improvement in 5 year survival rates to make it worthwhile.

Detailed Description: The endocrine therapy is generally proposed to all patients with endocrine positive early breast cancer to reduce the risk of recurrence and death. Moreover several data support that the prolongation of hormonal therapy (i.e. 10 years of hormonal treatment) is associated with statistical improved outcome. In order to achieve the benefit related to hormonal therapy all women have to be treated despite the fact that the data and analyses are unable to differentiate as to whether a small prolongation in survival accrues to all women treated or a few patients survive who would otherwise have died. Moreover the hormonal therapy is associated with side effects that may impact the quality of life of the patients. Patients are more likely to accept treatment on the basis of presented relative rather than absolute risks and so the question arises as to whether unrealistic improvements in outcome are expected by patients. The interviews with patients in the proposed trial will elicit the expected gains both in terms of survival and life years and will be able to assess the proportion of patients who considered an improvement of realistic size was sufficient to justify the treatment and the prolongation of the treatment. Several studies showed that choices are guided by the personal attitude to react and adapt to traumatic events, individual resilience. It is important therefore to consider also the influence of these factors on the patients' treatment preferences. For this reason, besides the elicitation of preferences, resilience and reaction to traumatic events will be assessed thorough validated questionnaires.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

European Institute of Oncology, Milan, , Italy

Contact Details

Name: Emilia Montagna, MD

Affiliation: European Institute of Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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