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AzTrials

Breast CancerINCANCT01510964

The Involvement of Breast Cancer Patients During Oncological Consultations

A study testing prompt-sheet in people with Breast Cancer, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main aim of the study is to assess if a pre consultation intervention facilitates greater participation of patients (and accompanying key persons when present) in the consultation process by determining an increase in questioning and/or in the number of different illness related issues (e.g. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
prompt-sheet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteItaly
Study dates
Jun 2011to May 2013
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • all consecutive patients
  • age between 18 and 75 years
  • attending the Oncology Out-patient Clinics of the participating centres
  • recent diagnosis of breast cancer at an early stage

Who cannot join

  • presence of metastasis or relapse
  • severe mental deterioration
  • comprehension difficulties of the Italian language.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Ospedaliera Universitaria Integrata

    Verona, 37134

Other trials in Italy

About this study

Official title: The Involvement of Breast Cancer Patients During Oncological Consultations. A Multi-centre Randomized Controlled Trial. The Study Protocol

The main aim of the study is to assess if a pre consultation intervention facilitates greater participation of patients (and accompanying key persons when present) in the consultation process by determining an increase in questioning and/or in the number of different illness related issues (e.g. diagnosis, treatment, prognosis) being discussed with the oncologist.

Other aims are to assess the effect of the intervention on the oncologist's level of patient involvement, on patient satisfaction and coping and to explore the role of key persons accompanying the patient.

The investigators expect that patients who have the opportunity to rehearse their informative needs before the consultation will ask a greater number of questions which in turn will determine their greater involvement by the physician and a greater number of satisfied needs. The investigators expect also that the straightforward use of a list of printed questions of potential relevance for cancer patients and their companions at an early stage of illness, by modifying the process of information exchange, increases their participation and satisfaction with the consultation, with potential benefits for treatment adherence and consequently treatment efficacy.

Conditions
Breast Cancer
Being tested
prompt-sheet, control group
Keywords
Breast cancer, Patient involvement, Question prompt-sheet, Doctor-patient communication, RCT
Medical subject headings
Breast Neoplasms, Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • prompt-sheetBehavioural

    Prompt sheet is a form on which to write the reply to the following request: "Please indicate the arguments which you want to discuss today with your oncologist" and a written list of possible questions the patient (companion) would like to ask to the oncology.

  • control groupBehavioural

    Patients and companions of the control group receive a form on which to write their reply to the following request: "Please indicate the arguments which you want to discuss today with your oncologist"

Study groups in NCT01510964
Study groupRoleWhat they receive
prompt-sheetExperimentalPatients and companions of intervention group receive a form on which to write their reply to the following request: "Please indicate the arguments which you want to discuss today with your oncologist" and the prompt sheet. An introduction explains the importance of asking questions during the consultations. The patient (companion) is invited to select among a written list of about 50 possible questions those, if any, s/he would like to ask today to the oncology.
Receives: Behavioral: prompt-sheet
control groupOtherPatients and companions of the control group receive a form on which to write their reply to the following request: "Please indicate the arguments which you want to discuss today with your oncologist"
Receives: Behavioral: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of question during the consultation

    The intervention prompt-sheet aims to increase the number of question by giving the opportunity to patients and companions to reflect on their informative needs on the basis of a wide range of possible questions from which to choose those perceived as most relevant in view of the subsequent consultation. Question asking is considered an index for patient participation during the consultation. The total number of patient questions during the consultation regarding diagnosis, prognosis, treatment and other issues is the primary outcome measure.

    Measured: 1 hour after the intervention (question prompt-sheet)

Secondary outcomes (8)

  1. The number of informative needs not met during the consultation.

    This measure is derived by comparing the number of questions indicated by patients and their companion before the consultation with those actually raised during the consultation

    Measured: 1 hour after the intervention (question prompt-sheet)

  2. Ability to cope with the illness

    the Patient Enablement Instrument (PEI) is a questionnaire of six items on a Likert scale from 0 (same or less) to 2 (much better, much more), administered after the consultation.

    Measured: 2 hours after the intervention (question prompt-sheet)

  3. Patient involvement (SDM-Q and OPTION)

    The SDM-Q is a self administered questionnaire of 9 items on a Likert scale from 1 to 6 and assesses patients' perception of the decisional process and their level of involvement during the consultation. The OPTION Scale is composed of 12 items of operational definitions of different patient involving skills, rated on a Likert scale from 0 to 4. The scale is applied by trained raters to the audio-recording of the consultation

    Measured: 2 hours after the intervention (question prompt-sheet)

  4. Satisfaction with decisions (SWD).

    Satisfaction with Decision Scale (SWD) is a questionnaireof 6 items on a Likert scale from 0 (completely disagree) to 5 (agree completely), administered after the consultation.

    Measured: 2 hours after the intervention (question prompt-sheet)

  5. Recalling and understanding of information

    The Recall Questionnaire consists of six questions which ask the patient's to recall the received information on treatment decisions and pathology. We added three other questions, rated on a 0 (no at al) to 5 (very much) likert scale asking whether the patient succeeded in their purpose of question asking, whether the oncologist answered the questions properly and how much more information she would have needed.

    Measured: 2 hours after the intervention (question prompt-sheet)

  6. Overall consultation atmosphere (VR-COPE, RIAS, AIMIT on the audio-recorded consultation)

    VRCOPE assesses the content, the process and relational aspects of patient-centred communication during medical consultations on the basis of a multidimensional evaluation and comprises nine items. RIAS is a coding system of medical consultations, composed by 40 categories describing interactions between doctors and patients. AIMIT is a coding system to assess in the therapeutic dialogue the activity of interpersonal motivational systems that guide the verbal and non verbal behaviors during interactions.

    Measured: 1 hour after the intervention (question prompt-sheet)

  7. Perceived Patient-doctor relationship (PDRQ-9 and DDPRQ-10)

    PDRQ-9 is a self-administered (after the consultation) questionnaire of 9 items on a Likert scale from 1 to 5, to measure the relationship between the doctor and the patient, from a patient point of view.The DDPRQ-10 is a self-report instrument of 10 items on a Likert scale from 1 to 6, completed by physicians after an encounter with a patient.

    Measured: 2 hours after the intervention (question prompt-sheet)

  8. Perceived role preference of the patient (CPS)

    CPS (Oncologist version) assesses how the oncologist perceives the role that patient might prefer regarding the decision making process.

    Measured: 2 hours after the intervention (question prompt-sheet)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2012 (estimated)
  2. Study startJun 2011
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01510964
Sponsor's protocol ID
INCA (CE.Prot. 1719)
Acronym
INCA
Status last verified
Dec 2011
First submitted
22 Dec 2011
Last updated
13 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Buizza C, Cela H, Ferrari C, Goss C, Bottacini A, Mazzi MA, Del Piccolo L, Ghilardi A. Does being accompanied make a difference in communication during breast cancer consultations? Results from a multi-centered randomized controlled trial. J Psychosoc Oncol. 2021;39(2):189-203. doi: 10.1080/07347332.2020.1829775. Epub 2020 Oct 22.

    PubMed 33089767

  • Buizza C, Ghilardi A, Mazzardi P, Barbera D, Fremondi V, Bottacini A, Mazzi MA, Goss C. Effects of a Question Prompt Sheet on the Oncologist-Patient Relationship: a Multi-centred Randomised Controlled Trial in Breast Cancer. J Cancer Educ. 2020 Jun;35(3):621-628. doi: 10.1007/s13187-019-01505-6.

    PubMed 30852786

  • Bottacini A, Goss C, Mazzi MA, Ghilardi A, Buizza C, Molino A, Fiorio E, Nortilli R, Amoroso V, Vassalli L, Brown RF. The involvement of early stage breast cancer patients during oncology consultations in Italy: a multi-centred, randomized controlled trial of a question prompt sheet versus question listing. BMJ Open. 2017 Aug 11;7(8):e015079. doi: 10.1136/bmjopen-2016-015079.

    PubMed 28801395

  • Goss C, Ghilardi A, Deledda G, Buizza C, Bottacini A, Del Piccolo L, Rimondini M, Chiodera F, Mazzi MA, Ballarin M, Bighelli I, Strepparava MG, Molino A, Fiorio E, Nortilli R, Caliolo C, Zuliani S, Auriemma A, Maspero F, Simoncini EL, Ragni F, Brown R, Zimmermann C. INvolvement of breast CAncer patients during oncological consultations: a multicentre randomised controlled trial--the INCA study protocol. BMJ Open. 2013 May 2;3(5):e002266. doi: 10.1136/bmjopen-2012-002266.

    PubMed 23645911

Questions about this trial

What is this clinical trial studying?

A study testing prompt-sheet in people with Breast Cancer, run by Azienda Ospedaliera Universitaria Integrata Verona 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 3 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: finished, as of the sponsor's last update on 13 Aug 2013. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of question during the consultation (time frame: 1 hour after the intervention (question prompt-sheet)). 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 NCT01510964, which also lists 4 linked publications.

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 13 Aug 2013.

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