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

• ClinicalTrials.gov Identifier: NCT03939156
• Recruitment Status: Active, not recruiting
• First Posted: May 6, 2019
• Last Update Posted: February 12, 2021
• Sponsor: European Institute of Oncology
• Information provided by (Responsible Party): European Institute of Oncology

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

• 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

Groups and Cohorts

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

• 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

Italy

European Institute of Oncology

Milan, Italy

Sponsors and Collaborators

European Institute of Oncology

Investigators

• Principal Investigator: Emilia Montagna, MD; European Institute of Oncology

More Information

• Responsible Party: European Institute of Oncology
• ClinicalTrials.gov Identifier: NCT03939156
• Other Study ID Numbers: IEO 0837/
• First Posted: May 6, 2019
• Last Update Posted: February 12, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by European Institute of Oncology:

adjuvant endocrine therapy; patient's preferences

Additional relevant MeSH terms:

Breast Neoplasms; Breast Diseases; Neoplasms by Site; Neoplasms; Skin Diseases