{ "FullStudy":{ "Rank":218236, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510964", "OrgStudyIdInfo":{ "OrgStudyId":"INCA (CE.Prot. 1719)" }, "Organization":{ "OrgFullName":"Azienda Ospedaliera Universitaria Integrata Verona", "OrgClass":"OTHER" }, "BriefTitle":"The Involvement of Breast Cancer Patients During Oncological Consultations", "OfficialTitle":"The Involvement of Breast Cancer Patients During Oncological Consultations. A Multi-centre Randomized Controlled Trial. The Study Protocol", "Acronym":"INCA" }, "StatusModule":{ "StatusVerifiedDate":"December 2011", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 22, 2011", "StudyFirstSubmitQCDate":"January 12, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 9, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 13, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Azienda Ospedaliera Universitaria Integrata Verona", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"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.\n\nOther 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.\n\nThe 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." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Breast Cancer" ] }, "KeywordList":{ "Keyword":[ "Breast cancer", "Patient involvement", "Question prompt-sheet", "Doctor-patient communication", "RCT" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"300", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"prompt-sheet", "ArmGroupType":"Experimental", "ArmGroupDescription":"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.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: prompt-sheet" ] } },{ "ArmGroupLabel":"control group", "ArmGroupType":"Other", "ArmGroupDescription":"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\"", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: control group" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"prompt-sheet", "InterventionDescription":"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.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "prompt-sheet" ] } },{ "InterventionType":"Behavioral", "InterventionName":"control group", "InterventionDescription":"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\"", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "control group" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"number of question during the consultation", "PrimaryOutcomeDescription":"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.", "PrimaryOutcomeTimeFrame":"1 hour after the intervention (question prompt-sheet)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"The number of informative needs not met during the consultation.", "SecondaryOutcomeDescription":"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", "SecondaryOutcomeTimeFrame":"1 hour after the intervention (question prompt-sheet)" },{ "SecondaryOutcomeMeasure":"Ability to cope with the illness", "SecondaryOutcomeDescription":"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.", "SecondaryOutcomeTimeFrame":"2 hours after the intervention (question prompt-sheet)" },{ "SecondaryOutcomeMeasure":"Patient involvement (SDM-Q and OPTION)", "SecondaryOutcomeDescription":"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", "SecondaryOutcomeTimeFrame":"2 hours after the intervention (question prompt-sheet)" },{ "SecondaryOutcomeMeasure":"Satisfaction with decisions (SWD).", "SecondaryOutcomeDescription":"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.", "SecondaryOutcomeTimeFrame":"2 hours after the intervention (question prompt-sheet)" },{ "SecondaryOutcomeMeasure":"Recalling and understanding of information", "SecondaryOutcomeDescription":"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.", "SecondaryOutcomeTimeFrame":"2 hours after the intervention (question prompt-sheet)" },{ "SecondaryOutcomeMeasure":"Overall consultation atmosphere (VR-COPE, RIAS, AIMIT on the audio-recorded consultation)", "SecondaryOutcomeDescription":"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.", "SecondaryOutcomeTimeFrame":"1 hour after the intervention (question prompt-sheet)" },{ "SecondaryOutcomeMeasure":"Perceived Patient-doctor relationship (PDRQ-9 and DDPRQ-10)", "SecondaryOutcomeDescription":"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.", "SecondaryOutcomeTimeFrame":"2 hours after the intervention (question prompt-sheet)" },{ "SecondaryOutcomeMeasure":"Perceived role preference of the patient (CPS)", "SecondaryOutcomeDescription":"CPS (Oncologist version) assesses how the oncologist perceives the role that patient might prefer regarding the decision making process.", "SecondaryOutcomeTimeFrame":"2 hours after the intervention (question prompt-sheet)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nall consecutive patients\nage between 18 and 75 years\nattending the Oncology Out-patient Clinics of the participating centres\nrecent diagnosis of breast cancer at an early stage\n\nExclusion Criteria:\n\npresence of metastasis or relapse\nsevere mental deterioration\ncomprehension difficulties of the Italian language.", "HealthyVolunteers":"No", "Gender":"Female", "MinimumAge":"18 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Claudia Goss", "OverallOfficialAffiliation":"Universita di Verona", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Azienda Ospedaliera Universitaria Integrata", "LocationCity":"Verona", "LocationZip":"37134", "LocationCountry":"Italy" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"30852786", "ReferenceType":"derived", "ReferenceCitation":"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. 2019 Mar 9. doi: 10.1007/s13187-019-01505-6. [Epub ahead of print]" },{ "ReferencePMID":"28801395", "ReferenceType":"derived", "ReferenceCitation":"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." },{ "ReferencePMID":"23645911", "ReferenceType":"derived", "ReferenceCitation":"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). pii: e002266. doi: 10.1136/bmjopen-2012-002266." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001943", "ConditionMeshTerm":"Breast Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000001941", "ConditionAncestorTerm":"Breast Diseases" },{ "ConditionAncestorId":"D000012871", "ConditionAncestorTerm":"Skin Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3802", "ConditionBrowseLeafName":"Breast Neoplasms", "ConditionBrowseLeafAsFound":"Breast Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3800", "ConditionBrowseLeafName":"Breast Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }