PrefeRences And ChemoTherapy In Breast Cancer patiEnts

NCT06332976 | Recruiting

• 1 other identifier: IEO 1521
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Female Breast Cancer

Keywords

Early breast cancer; Locally advanced breast cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Behavior assessment

  1 week

• Reaction to uncertain situations assessment

  1 week

• Regret and disappointment assessment

  1 week

Study Arms (3)

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

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

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

Interventions

Completion of questionnaires OTHER

Completion of questionnaires at the time of study entry

After chemotherapy end; Before chemotherapy start; During chemotherapy

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

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

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Emilia Montagna, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilia Montagna, MD

CONTACT

+390257489970; emilia.montagna@ieo.it

Study Design

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

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 27, 2024
• Study Start: June 4, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

IT (1)