The Involvement of Breast Cancer Patients During Oncological Consultations

NCT01510964 | Completed DMC

• 1 other identifier: INCA (CE.Prot. 1719)
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Patient involvement; Question prompt-sheet; Doctor-patient communication; RCT

Outcome Measures

Primary Outcomes (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.

  1 hour after the intervention (question prompt-sheet)

Secondary Outcomes (8)

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

  1 hour after the intervention (question prompt-sheet)

• Ability to cope with the illness

  2 hours after the intervention (question prompt-sheet)

• Patient involvement (SDM-Q and OPTION)

  2 hours after the intervention (question prompt-sheet)

• Satisfaction with decisions (SWD).

  2 hours after the intervention (question prompt-sheet)

• Recalling and understanding of information

  2 hours after the intervention (question prompt-sheet)

Study Arms (2)

prompt-sheet

EXPERIMENTAL

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.

Behavioral: prompt-sheet

control group

OTHER

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"

Behavioral: control group

Interventions

prompt-sheet BEHAVIORAL

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.

prompt-sheet

control group BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata

Verona, 37134, Italy

Location

Related Publications (4)

• 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.

  PMID: 33089767 DERIVED

• 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.

  PMID: 30852786 DERIVED

• 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.

  PMID: 28801395 DERIVED

• 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.

  PMID: 23645911 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Patient Participation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Claudia Goss

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 18, 2012
• Study Start: June 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2011-12

Locations

IT (1)