Clinical trial · Interventional
The Involvement of Breast Cancer Patients During Oncological Consultations
The Involvement of Breast Cancer Patients During Oncological Consultations. A Multi-centre Randomized Controlled Trial. The Study Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| control group | Behavioral | — | UNRESOLVED |
| prompt-sheet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- prompt-sheet
- description
- Patients 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.
- interventionNames
- Behavioral: prompt-sheet
- type
- OTHER
- label
- control group
- description
- 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"
- interventionNames
- Behavioral: control group
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * presence of metastasis or relapse * severe mental deterioration * comprehension difficulties of the Italian language.
References
Publications (4)
- DERIVEDBuizza 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. PMID 33089767
- DERIVEDBuizza 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. PMID 30852786
- DERIVEDBottacini 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. PMID 28801395
- DERIVEDGoss 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. PMID 23645911