Breast CancerNCT02312700
An Interactive Empowerment Tool for Breast Cancer Patients
A study testing Interactive empowerment tool in people with Breast Cancer and Empowerment, run by University of Milan.
Trial summary
The study is aimed to verify the effect of an online interactive tool on patient empowerment. The tool is based on a validated psychological questionnaire administrated to breast cancer patients before their first encounter with physician. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women only
- Conditions the study is for
- Breast Cancer, Empowerment
- What is being tested?
- Interactive empowerment tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- 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 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is aged 18 to 74 years at randomisation.
- The patient has been diagnosed as having a primary breast cancer requiring a radical surgery
- The patient is able to understand the Informed Consent Form, and understand study procedures.
- The patient has signed the Informed Consent Form.
Who cannot join
- The patient has a recurrent breast cancer diagnosis
- The patient has an overt psychiatric illness that would interfere with the measurement of the psychological variables included in the questionnaire
- Inability to freely consent to take part in the study
- Inability to understand the study materials.
- Current participation in another clinical trial relating to the breast cancer treatment
- Any condition that, in the researcher's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
Trial locations and contacts
No sites are listed yet.
Alessandra Gorini, PhD contact
About this study
Official title: Development of an Interactive Empowerment Tool in Support of Patient Empowerment.
The study is aimed to verify the effect of an online interactive tool on patient empowerment. The tool is based on a validated psychological questionnaire administrated to breast cancer patients before their first encounter with physician.
Read the detailed description
The study is intended to develop an IEm (Interactive Empowerment) tool aimed at enhancing physician-patient experience by providing physicians a personalized patient's profile, accompanied by a list of recommendations to suggest him how to interact with that specific patient on the basis of his/her personal profile. Developed in the framework of the FP7 project "P-Medicine", the IEm tool uses the ALGA-BC questionnaire, a recent validated instrument specifically developed to perform a brief evaluation of the breast cancer patients' psychological status, to provide the physician a patient's profile based on 8 factors. As soon as the questionnaire has been completed, the patient's answers are automatically elaborated and sent to the physician's computer. Provided to the physicians at the very beginning of the visit, such information is supposed to be crucial for them to find a tailored way to communicate with the patient. Moreover, in order to help physicians to correctly interpret the patient's score, any time the scores are out of a certain range (normal values) they will receive a recommendation that helps them to find the best way to interact with the patient. Supposing that the patient empowerment can be reached through the improved patient's participation in the clinical process, we argue that a more effective and personalized interaction between patient and physician may have a key role in promoting it.
- Conditions
- Breast Cancer, Empowerment
- Being tested
- Interactive empowerment tool
- Keywords
- empowerment, communication, shared decision making
- Medical subject headings
- Breast Neoplasms, Empowerment, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive empowerment toolBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Interactive empowerment (IEm) group | Experimental | Intervention: Patients fill in the questionnaire online and their profile (obtained from their answers) is immediately sent to the physician Receives: Behavioral: Interactive empowerment tool |
| Control | Sham comparator | Intervention: Patients fill in the questionnaire online, but their profile (obtained from their answers) is not sent to the physician Receives: Behavioral: Interactive empowerment tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in the Patient Empowerment Score
Patient empowerment score will be measured in the experimental versus the control group by mean of patients' comprehension level relatively to the information doctors provided to them.
Measured: Up to 30 min after the visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Gorini, University of Milan
- Investigators
- Elisabetta Munzono, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312700
- Sponsor's protocol ID
- 270089
- Status last verified
- Dec 2014
- First submitted
- 28 Nov 2014
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kondylakis H, Kazantzaki E, Koumakis L, Genitsaridi I, Marias K, Gorini A, Mazzocco K, Pravettoni G, Burke D, McVie G, Tsiknakis M. Development of interactive empowerment services in support of personalised medicine. Ecancermedicalscience. 2014 Feb 11;8:400. doi: 10.3332/ecancer.2014.400. eCollection 2014.
PubMed 24567757
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Interactive Empowerment Tool in Support of Patient Empowerment.
- ClinicalTrials.gov ID
- NCT02312700
- Acronym / sponsor ID
- 270089
- Conditions
- Breast Cancer, Empowerment
- Keywords
- empowerment, communication, shared decision making
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Dec 2014 (estimated)
- 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 study is aimed to verify the effect of an online interactive tool on patient empowerment. The tool is based on a validated psychological questionnaire administrated to breast cancer patients before their first encounter with physician.
Detailed description
The study is intended to develop an IEm (Interactive Empowerment) tool aimed at enhancing physician-patient experience by providing physicians a personalized patient's profile, accompanied by a list of recommendations to suggest him how to interact with that specific patient on the basis of his/her personal profile. Developed in the framework of the FP7 project "P-Medicine", the IEm tool uses the ALGA-BC questionnaire, a recent validated instrument specifically developed to perform a brief evaluation of the breast cancer patients' psychological status, to provide the physician a patient's profile based on 8 factors. As soon as the questionnaire has been completed, the patient's answers are automatically elaborated and sent to the physician's computer. Provided to the physicians at the very beginning of the visit, such information is supposed to be crucial for them to find a tailored way to communicate with the patient. Moreover, in order to help physicians to correctly interpret the patient's score, any time the scores are out of a certain range (normal values) they will receive a recommendation that helps them to find the best way to interact with the patient. Supposing that the patient empowerment can be reached through the improved patient's participation in the clinical process, we argue that a more effective and personalized interaction between patient and physician may have a key role in promoting it.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive empowerment (IEm) group | Experimental | Behavioral: Interactive empowerment toolIntervention: Patients fill in the questionnaire online and their profile (obtained from their answers) is immediately sent to the physician |
| Control | Sham comparator | Behavioral: Interactive empowerment toolIntervention: Patients fill in the questionnaire online, but their profile (obtained from their answers) is not sent to the physician |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is aged 18 to 74 years at randomisation.
- The patient has been diagnosed as having a primary breast cancer requiring a radical surgery
- The patient is able to understand the Informed Consent Form, and understand study procedures.
- The patient has signed the Informed Consent Form.
Key exclusion criteria (6 listed)
- The patient has a recurrent breast cancer diagnosis
- The patient has an overt psychiatric illness that would interfere with the measurement of the psychological variables included in the questionnaire
- Inability to freely consent to take part in the study
- Inability to understand the study materials.
- Current participation in another clinical trial relating to the breast cancer treatment
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 |
|---|---|---|
| Interactive empowerment tool | Behavioural | Control, Interactive empowerment (IEm) group |
Primary outcome
Improvements in the Patient Empowerment Score
Time frame: Up to 30 min after the visit
Patient empowerment score will be measured in the experimental versus the control group by mean of patients' comprehension level relatively to the information doctors provided to them.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- Background: PubMed 24567757Kondylakis H, Kazantzaki E, Koumakis L, Genitsaridi I, Marias K, Gorini A, Mazzocco K, Pravettoni G, Burke D, McVie G, Tsiknakis M. Development of interactive empowerment services in support of personalised medicine. Ecancermedicalscience. 2014 Feb 11;8:400. doi: 10.3332/ecancer.2014.400. eCollection 2014.
- Web page of the European project in which the present trial is includedLink provided by the sponsor.
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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.
Alessandra Gorini, PhD contact
Elisabetta Munzono, MD principal investigator
European Institute of Oncology
Questions about this trial
What is this clinical trial studying?
A study testing Interactive empowerment tool in people with Breast Cancer and Empowerment, run by University of Milan.
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 6 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 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Alessandra Gorini, PhD (alessandra.gorini@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvements in the Patient Empowerment Score (time frame: Up to 30 min after the visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02312700, which also lists 1 linked publication.
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 9 Dec 2014.