The Involvement of Breast Cancer Patients During Oncological Consultations (INCA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier:
NCT01510964
First received: December 22, 2011
Last updated: August 9, 2013
Last verified: December 2011
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: prompt-sheet
Behavioral: control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Involvement of Breast Cancer Patients During Oncological Consultations. A Multi-centre Randomized Controlled Trial. The Study Protocol

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Universitaria Integrata Verona:

Primary Outcome Measures:
  • number of question during the consultation [ Time Frame: 1 hour after the intervention (question prompt-sheet) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The number of informative needs not met during the consultation. [ Time Frame: 1 hour after the intervention (question prompt-sheet) ] [ Designated as safety issue: No ]
    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

  • Ability to cope with the illness [ Time Frame: 2 hours after the intervention (question prompt-sheet) ] [ Designated as safety issue: No ]
    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.

  • Patient involvement (SDM-Q and OPTION) [ Time Frame: 2 hours after the intervention (question prompt-sheet) ] [ Designated as safety issue: No ]
    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

  • Satisfaction with decisions (SWD). [ Time Frame: 2 hours after the intervention (question prompt-sheet) ] [ Designated as safety issue: No ]
    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.

  • Recalling and understanding of information [ Time Frame: 2 hours after the intervention (question prompt-sheet) ] [ Designated as safety issue: No ]
    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.

  • Overall consultation atmosphere (VR-COPE, RIAS, AIMIT on the audio-recorded consultation) [ Time Frame: 1 hour after the intervention (question prompt-sheet) ] [ Designated as safety issue: No ]
    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.

  • Perceived Patient-doctor relationship (PDRQ-9 and DDPRQ-10) [ Time Frame: 2 hours after the intervention (question prompt-sheet) ] [ Designated as safety issue: No ]
    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.

  • Perceived role preference of the patient (CPS) [ Time Frame: 2 hours after the intervention (question prompt-sheet) ] [ Designated as safety issue: No ]
    CPS (Oncologist version) assesses how the oncologist perceives the role that patient might prefer regarding the decision making process.


Enrollment: 300
Study Start Date: June 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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"
Behavioral: 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510964

Locations
Italy
Azienda Ospedaliera Universitaria Integrata
Verona, Italy, 37134
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
Investigators
Principal Investigator: Claudia Goss Universita di Verona
  More Information

No publications provided

Responsible Party: Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier: NCT01510964     History of Changes
Other Study ID Numbers: INCA (CE.Prot. 1719)
Study First Received: December 22, 2011
Last Updated: August 9, 2013
Health Authority: Scientific Committee: Prof. Christa Zimmermann, Prof. Lidia Del Piccolo

Keywords provided by Azienda Ospedaliera Universitaria Integrata Verona:
Breast cancer
Patient involvement
Question prompt-sheet
Doctor-patient communication
RCT

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014