Female Breast CancerPRACTICENCT06332976
PrefeRences And ChemoTherapy In Breast Cancer patiEnts
An observational study of Female Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Breast Cancer
- What is being tested?
- Completion of questionnaires
- How many people
- 450 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jun 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients candidate to or who are receiving/have already redceived adjuvant or neoadjuvant chemotherapy
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, 20141
Emilia Montagna, MD, +390257489970, emilia.montagna@ieo.it
About this study
Official title: 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:
- before to start the chemotherapy
- during chemotherapy
- after the end of chemotherapy
Read the 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.
- Conditions
- Female Breast Cancer
- Being tested
- Completion of questionnaires
- Keywords
- Early breast cancer, Locally advanced breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion of questionnairesOther
Completion of questionnaires at the time of study entry
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Other: Completion of questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 week
Secondary outcomes (3)
Behavior assessment
Collection of CONOR questionnaire (minimum value: 0, maximum value: 5 - higher scores mean a greater agreement with the statement)
Measured: 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)
Measured: 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)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start4 Jun 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilia Montagna, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332976
- Sponsor's protocol ID
- IEO 1521
- Acronym
- PRACTICE
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Preferences for Adjuvant or Neoadjuvant Chemotherapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT06332976
- Acronym / sponsor ID
- PRACTICE / IEO 1521
- Conditions
- Female Breast Cancer
- Keywords
- Early breast cancer, Locally advanced breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- before to start the chemotherapy
- during chemotherapy
- after the end of chemotherapy
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Before chemotherapy start | – | Other: Completion of questionnairesWomen candidate to adjuvant or neoadjuvant chemotherapy for breast cancer at the time of informed consent (interview before the start of CT) |
| During chemotherapy | – | Other: Completion of questionnairesWomen who are receiving chemotherapy at the time of informed consent (interview within 1 year from beginning of CT) |
| After chemotherapy end | – | Other: Completion of questionnairesWomen who already received chemotherapy at the time of informed consent (interview after more than 4 years of CT end) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients candidate to or who are receiving/have already redceived adjuvant or neoadjuvant chemotherapy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Completion of questionnairesCompletion of questionnaires at the time of study entry | Other | After chemotherapy end, Before chemotherapy start, During chemotherapy |
Primary outcome
Percentage of risk reduction needed to consider adjuvant or neoadjuvant chemotherapy worthwhile
Time frame: 1 week
Risk reduction will be evaluated in the 40% and 20% 5 years risk scenarios
Prolonged survival time gain needed to consider CT worthwhile
Time frame: 1 week
Prolonged survival time gain will be evaluated in the 5-yr and 15-yr survival scenarios
3 secondary outcomes
Behavior assessment
Time frame: 1 week
Reaction to uncertain situations assessment
Time frame: 1 week
Regret and disappointment assessment
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia Montagna, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilia Montagna, MD (+390257489970, emilia.montagna@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of risk reduction needed to consider adjuvant or neoadjuvant chemotherapy worthwhile (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.