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Completed

NCT Number: NCT01510964

The Involvement of Breast Cancer Patients During Oncological Consultations

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera Universitaria Integrata

Verona, 37134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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"

Primary outcomes

  1. number of question during the consultation

    Time frame: 1 hour after the intervention (question prompt-sheet)

    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 outcomes

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

    Time frame: 1 hour after the intervention (question prompt-sheet)

    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

  2. Ability to cope with the illness

    Time frame: 2 hours after the intervention (question prompt-sheet)

    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.

  3. Patient involvement (SDM-Q and OPTION)

    Time frame: 2 hours after the intervention (question prompt-sheet)

    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

  4. Satisfaction with decisions (SWD).

    Time frame: 2 hours after the intervention (question prompt-sheet)

    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.

  5. Recalling and understanding of information

    Time frame: 2 hours after the intervention (question prompt-sheet)

    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.

  6. Overall consultation atmosphere (VR-COPE, RIAS, AIMIT on the audio-recorded consultation)

    Time frame: 1 hour after the intervention (question prompt-sheet)

    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.

  7. Perceived Patient-doctor relationship (PDRQ-9 and DDPRQ-10)

    Time frame: 2 hours after the intervention (question prompt-sheet)

    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.

  8. Perceived role preference of the patient (CPS)

    Time frame: 2 hours after the intervention (question prompt-sheet)

    CPS (Oncologist version) assesses how the oncologist perceives the role that patient might prefer regarding the decision making process.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

The Involvement of Breast Cancer Patients During Oncological Consultations. A Multi-centre Randomized Controlled Trial. The Study Protocol

Acronym: INCA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 18, 2012
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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