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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Active Comparator | Quality of life questionnaires (electronic patient reported outcomes) to be filled out by the patients at every visit. Quality of life data is fully available for physicians. Paper-based questionnaire (EORTC QLQ-COMU26) at baseline, after three months and after six months. |
|
| Control Arm | Placebo Comparator | Quality of life questionnaires (electronic patient reported outcomes) only to filled out by the patients at baseline, after three months and after six months. Quality of life data is hidden for physicians. Paper-based questionnaire (EORTC QLQ-COMU26) at baseline, after three months and after six months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | Quality of life questionnaires on iPads with CHES (Computer-based Health Evaluation System), paper-based questionnaire (EORTC QLQ-COMU26) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to six months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessment | Quality of life will be assessed electronically with EORTC QLQ-C30. | Arm A: at every visit for six months; Arm B: at baseline, three months, six months |
| Frequency of discontinuations of therapy |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vera Trommet, Dr. | Klinikum Wels-Grieskirchen GmbH, 4. Interne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.ö. Krankenhaus St. Josef Braunau GmbH | Braunau am Inn | Upper Austria | 5280 | Austria | ||
| Klinikum Wels-Grieskirchen GmbH |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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The frequency of discontinuations will be assessed based on medical reports.
| 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. | At baseline, three months, six months in both groups |
| Wels |
| Upper Austria |
| 4600 |
| Austria |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |