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出境医 / 临床实验 / Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer (ELENA)

Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer (ELENA)

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.


Condition or disease Intervention/treatment
Breast Cancer Endocrine Breast Diseases Other: Completion of questionnaires

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Endocrine Therapy and Patients Preferences in Early Breast Cancer - Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer.
Actual Study Start Date : June 5, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
Group 1 - before starting ET
women candidate to receive ET and interviewed before starting treatment
Other: Completion of questionnaires
Completion of questionnaires at the time of study entry

Group 2 - within 1 year of ET
women interviewed within 1 years from beginning of ET
Other: Completion of questionnaires
Completion of questionnaires at the time of study entry

Group 3 - between 4 and 6 years of ET
women interviewed after more than 4 years but no more than 6 years of ET
Other: Completion of questionnaires
Completion of questionnaires at the time of study entry

Outcome Measures
Primary Outcome Measures :
  1. Percentage of risk reduction needed to consider endocrine therapy worthwhile [ Time Frame: 1 week ]
    Risk reduction will be evaluated in the 40% and 20% 5 years risk scenarios

  2. Number of years gain needed to consider ET worthwhile [ Time Frame: 1 week ]
    Prolonged survival time gain will be evaluated in the 5-yr and 15-yr survival scenarios


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hormonal receptors positive breast cancer candidate to adjuvant hormonal therapy or who are receiving hormonal therapy (within 1 year from beginning for group 2 and who are received at least 4 or 5 or 6 years of hormonal therapy)
Criteria

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)
Contacts and Locations

Locations
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Italy
European Institute of Oncology
Milan, Italy
Sponsors and Collaborators
European Institute of Oncology
Investigators
Layout table for investigator information
Principal Investigator: Emilia Montagna, MD European Institute of Oncology
Tracking Information
First Submitted Date April 4, 2019
First Posted Date May 6, 2019
Last Update Posted Date February 12, 2021
Actual Study Start Date June 5, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2019)
  • Percentage of risk reduction needed to consider endocrine therapy worthwhile [ Time Frame: 1 week ]
    Risk reduction will be evaluated in the 40% and 20% 5 years risk scenarios
  • Number of years gain needed to consider ET worthwhile [ Time Frame: 1 week ]
    Prolonged survival time gain will be evaluated in the 5-yr and 15-yr survival scenarios
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with hormonal receptors positive breast cancer candidate to adjuvant hormonal therapy or who are receiving hormonal therapy (within 1 year from beginning for group 2 and who are received at least 4 or 5 or 6 years of hormonal therapy)
Condition
  • Breast Cancer
  • Endocrine Breast Diseases
Intervention Other: Completion of questionnaires
Completion of questionnaires at the time of study entry
Study Groups/Cohorts
  • Group 1 - before starting ET
    women candidate to receive ET and interviewed before starting treatment
    Intervention: Other: Completion of questionnaires
  • Group 2 - within 1 year of ET
    women interviewed within 1 years from beginning of ET
    Intervention: Other: Completion of questionnaires
  • Group 3 - between 4 and 6 years of ET
    women interviewed after more than 4 years but no more than 6 years of ET
    Intervention: Other: Completion of questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: May 3, 2019)
450
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03939156
Other Study ID Numbers IEO 0837/
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party European Institute of Oncology
Study Sponsor European Institute of Oncology
Collaborators Not Provided
Investigators
Principal Investigator: Emilia Montagna, MD European Institute of Oncology
PRS Account European Institute of Oncology
Verification Date February 2021

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