Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer

Breast Cancer Clinical Trial

— ELENA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03939156
• Other study ID #: IEO 0837/
• Status: Active, not recruiting
• Start date: June 5, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women candidate to adjuvant hormonal therapy for breast cancer before the start of therapy
• Women who are receiving hormonal therapy (within 1 year from beginning)
• Women who are receiving hormonal therapy (who had receive at least 4 or 5 or 6 years of hormonal therapy)
• Patients who underwent to radical surgery for breast cancer
• Patients who have received neoadjuvant or adjuvant chemotherapy are also eligible
• Hormonal receptors positive breast cancer (ER and or PgR >1%)
• Sufficient literacy in Italian to complete the questionnaires.

Exclusion Criteria:

• Patients who had received at least 1 year and no more than 3 years of hormonal therapy
• Patients who are receiving hormonal therapy (who had receive 7 years or more of hormonal therapy)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases
• Breast Neoplasms
• Endocrine Breast Diseases

Intervention

Other:
• Completion of questionnaires
Completion of questionnaires at the time of study entry

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of risk reduction needed to consider endocrine therapy worthwhile	Risk reduction will be evaluated in the 40% and 20% 5 years risk scenarios	1 week
Primary	Number of years gain needed to consider ET worthwhile	Prolonged survival time gain will be evaluated in the 5-yr and 15-yr survival scenarios	1 week