Study Evaluating the Impact of Electronic Surveys on Patient-physician Communication and Quality of Life in Breast Cancer Patients

Dr. Vera Trommet62 enrolled

Overview

PRO-COM Project: Randomized-controlled study evaluating the impact of electronic patient reported outcome (ePRO) surveys on patient-physician communication and quality of life in patients with advanced breast cancer

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Breast Neoplasm Malignant Female

Interventions

QuestionnairesOTHER

Quality of life questionnaires on iPads with CHES (Computer-based Health Evaluation System), paper-based questionnaire (EORTC QLQ-COMU26)

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * Stage IV breast cancer * Start of a systemic anti cancer therapy: chemotherapy -/+ antibody therapy 1st until 3rd line (palliative), endocrine therapy or other therapy without limit * Estimated life expectancy of minimum six months * Signed informed consent * No cognitive or speech impairments

Locations (2)

A.ö. Krankenhaus St. Josef Braunau GmbH

Braunau am Inn, Upper Austria, Austria

Klinikum Wels-Grieskirchen GmbH

Wels, Upper Austria, Austria

Outcomes

Primary Outcomes

Patient-physician communication

The communication between patient and physician will be assessed with EORTC QLQ-COMU26. Presumably some patients have privacy concerns with electronic questionnaires. The EORTC-COMU26 is the most important questionnaire in this study because it is needed for the primary endpoint. It contains sensitive questions about how the patient experiences the communication during the visit. In order to avoid patients not filling out the questionnaire due to privacy concerns or being afraid of giving an honest opinion and the physician could read it electronically, the EORTC QLQ-COMU26 is paper-based and the patients can hand them in in the study office.

Time frame: Up to six months

Secondary Outcomes

Quality of life assessment

Quality of life will be assessed electronically with EORTC QLQ-C30.

Time frame: Arm A: at every visit for six months; Arm B: at baseline, three months, six months

Frequency of discontinuations of therapy

The frequency of discontinuations will be assessed based on medical reports.

Time frame: Up to six months

Duration of communication between physician and patient

Physicians call the study office at the beginning and at the end of the consultation at baseline, three months and six months. They will record the duration of the consultation.

Time frame: At baseline, three months, six months in both groups

Data from ClinicalTrials.gov

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