Breast Neoplasm Malignant Female
Conditions
Brief summary
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
Interventions
OTHERQuestionnaires
Quality of life questionnaires on iPads with CHES (Computer-based Health Evaluation System), paper-based questionnaire (EORTC QLQ-COMU26)
Sponsors
Dr. Vera Trommet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-physician communication | Up to six months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment | Arm A: at every visit for six months; Arm B: at baseline, three months, six months | Quality of life will be assessed electronically with EORTC QLQ-C30. |
| Frequency of discontinuations of therapy | Up to six months | The frequency of discontinuations will be assessed based on medical reports. |
| Duration of communication between physician and patient | At baseline, three months, six months in both groups | 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. |
Countries
Austria
Outcome results
None listed