PrefeRences And ChemoTherapy In Breast Cancer patiEnts (PRACTICE)

Patients' Preferences for Adjuvant or Neoadjuvant Chemotherapy in Breast Cancer

The aim of the present study is to ask women treated with adjuvant or neoadjuvant chemotherapy for breast cancer what survival benefit would justify the treatment.

The benefit should be evaluated in terms of Survival rate trade off and Survival time trade off value. The analyses will be conducted into three different groups of patients to value the survival benefit expected:

1. before to start the chemotherapy
2. during chemotherapy
3. after the end of chemotherapy

Study Overview

• Status: Recruiting
• Conditions: Female Breast Cancer
• Intervention / Treatment: Other: Completion of questionnaires

Detailed Description

The chemotherapy is generally proposed a large number of early breast cancer patients to reduce the risk of recurrence and death. However chemotherapy is associated with side effects that 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.

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Emilia Montagna, MD; Phone Number: +390257489970; Email: emilia.montagna@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20141
    • Recruiting
    • European Institute of Oncology
    • Contact: Emilia Montagna, MD; Phone Number: +390257489970; Email: emilia.montagna@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients candidate to or who are receiving/have already redceived adjuvant or neoadjuvant chemotherapy

Description

Inclusion Criteria:

• Patients with early or locally advanced breast cancer
• Patients candidate to adjuvant/neoadjuvant chemotherapy or patients who are receiving adjuvant/neoadjuvant chemotherapy or patients who received adjuvant/neoadjuvant chemotherapy
• Sufficient literacy in Italian to complete the questionnaires
• Patients must provide signed, written or advanced electronic signature (AES or AdES), informed consent

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before chemotherapy start; Women candidate to adjuvant or neoadjuvant chemotherapy for breast cancer at the time of informed consent (interview before the start of CT)	Other: Completion of questionnaires; Completion of questionnaires at the time of study entry
During chemotherapy; Women who are receiving chemotherapy at the time of informed consent (interview within 1 year from beginning of CT)	Other: Completion of questionnaires; Completion of questionnaires at the time of study entry
After chemotherapy end; Women who already received chemotherapy at the time of informed consent (interview after more than 4 years of CT end)	Other: Completion of questionnaires; Completion of questionnaires at the time of study entry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of risk reduction needed to consider adjuvant or neoadjuvant chemotherapy worthwhile	Risk reduction will be evaluated in the 40% and 20% 5 years risk scenarios	1 week
Prolonged survival time gain needed to consider CT worthwhile	Prolonged survival time gain will be evaluated in the 5-yr and 15-yr survival scenarios	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior assessment	Collection of CONOR questionnaire (minimum value: 0, maximum value: 5 - higher scores mean a greater agreement with the statement)	1 week
Reaction to uncertain situations assessment	Collection of Intolerance of Uncertainty Scale Short-Form (IUS-12) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)	1 week
Regret and disappointment assessment	Collection of Regret and Disappointment Scale (RDS) questionnaire (minimum value: 1, maximum value: 7 - higher scores mean a greater agreement with the statement)	1 week

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Locally advanced breast cancer; Early breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IEO 1521

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No