Clinical trial NCT01510964: The Involvement of Breast Cancer Patients During Oncological Consultations
Official title: The Involvement of Breast Cancer Patients During Oncological Consultations. A Multi-centre Randomized Controlled Trial. The Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Patient involvement
Question prompt-sheet
Doctor-patient communication
RCT
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2012-01-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: number of question during the consultation
timeFrame: 1 hour after the intervention (question prompt-sheet)
Secondary outcomes:
measure: The number of informative needs not met during the consultation.
timeFrame: 1 hour after the intervention (question prompt-sheet)
measure: Ability to cope with the illness
timeFrame: 2 hours after the intervention (question prompt-sheet)
measure: Patient involvement (SDM-Q and OPTION)
timeFrame: 2 hours after the intervention (question prompt-sheet)
measure: Satisfaction with decisions (SWD).
timeFrame: 2 hours after the intervention (question prompt-sheet)
measure: Recalling and understanding of information
timeFrame: 2 hours after the intervention (question prompt-sheet)
measure: Overall consultation atmosphere (VR-COPE, RIAS, AIMIT on the audio-recorded consultation)
timeFrame: 1 hour after the intervention (question prompt-sheet)
measure: Perceived Patient-doctor relationship (PDRQ-9 and DDPRQ-10)
timeFrame: 2 hours after the intervention (question prompt-sheet)
measure: Perceived role preference of the patient (CPS)
timeFrame: 2 hours after the intervention (question prompt-sheet)
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata
Study officials:
affiliation: Universita di Verona
name: Claudia Goss
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.