Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer

NCT03939156 | Unknown

• 1 other identifier: IEO 0837/
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Endocrine Breast Diseases

Keywords

adjuvant endocrine therapy; patient's preferences

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Group 1 - before starting ET

women candidate to receive ET and interviewed before starting treatment

Other: Completion of questionnaires

Group 2 - within 1 year of ET

women interviewed within 1 years from beginning of ET

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

Other: Completion of questionnaires

Interventions

Completion of questionnaires OTHER

Completion of questionnaires at the time of study entry

Group 1 - before starting ET; Group 2 - within 1 year of ET; Group 3 - between 4 and 6 years of ET

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Emilia Montagna, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: May 6, 2019
• Study Start: June 5, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

IT (1)