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

Integrated University Hospital Trust of Verona

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: control group; Behavioral: prompt-sheet

Study type: Interventional

Funder types: Other

Identifiers

NCT01510964

INCA (CE.Prot. 1719)

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

prompt-sheet

Experimental group

Description:

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.

Treatment:

Behavioral: prompt-sheet

control group

Other group

Description:

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"

Treatment:

Behavioral: control group