Study Evaluating the Impact of Electronic Surveys on Patient-physician Communication and Quality of Life in Breast Cancer Patients
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intervention Arm 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. |
Other: Questionnaires
Quality of life questionnaires on iPads with CHES (Computer-based Health Evaluation System), paper-based questionnaire (EORTC QLQ-COMU26)
|
| Placebo Comparator: Control Arm 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. |
Other: Questionnaires
Quality of life questionnaires on iPads with CHES (Computer-based Health Evaluation System), paper-based questionnaire (EORTC QLQ-COMU26)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Quality of life [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | A.รถ. Krankenhaus St. Josef Braunau GmbH | Braunau Am Inn | Upper Austria | Austria | 5280 |
| 2 | Klinikum Wels-Grieskirchen GmbH | Wels | Upper Austria | Austria | 4600 |
Sponsors and Collaborators
- Dr. Vera Trommet
Investigators
- Principal Investigator: Vera Trommet, Dr., Klinikum Wels-Grieskirchen GmbH, 4. Interne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017/01