The Involvement of Breast Cancer Patients During Oncological Consultations
NCT ID: NCT01510964
Last Updated: 2013-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2011-06-30
2013-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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prompt-sheet
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.
prompt-sheet
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 group
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"
control group
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"
Interventions
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prompt-sheet
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 group
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"
Eligibility Criteria
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Inclusion Criteria
* 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
* severe mental deterioration
* comprehension difficulties of the Italian language.
18 Years
75 Years
FEMALE
No
Sponsors
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Azienda Ospedaliera Universitaria Integrata Verona
OTHER
Responsible Party
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Principal Investigators
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Claudia Goss
Role: PRINCIPAL_INVESTIGATOR
Universita di Verona
Locations
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Azienda Ospedaliera Universitaria Integrata
Verona, , Italy
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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INCA (CE.Prot. 1719)
Identifier Type: -
Identifier Source: org_study_id