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This study is a single arm feasibility study. Patients that have been diagnosed with carcinoma and are undergoing chemotherapy have to document chemotherapy associated side effects on a regular basis by means of a tablet-based online questionnaire. Goal of the study is to find out if patients that are undergoing chemotherapy are willing to document chemotherapy associated side effects by means of a tablet-based online questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tablet-based reported outcome | Experimental | With the start of chemotherapy until the end of the last cycle of chemotherapy the study participants have to document all signs of discomfort or changes to their overall coenesthesia in the tablet-based questionnaire. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tablet-based questionnaire | Device | tablet-based patient reported outcomes (TabPRO) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Tablet-based questionnaire of PRO | Feasibility of Tablet-based questionnaire of PRO (>60% of patients answer >60% of questionnaires in the time frame of study duration) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Answered questionnaires per patient | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Mallmann, MD | Department of Obstetrics & Gynecology, University Hospital Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics & Gynecology, Evangelisches Krankenhaus Bergisch-Gladbach | Bergisch Gladbach | Germany | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17855485 | Background | Lipscomb J, Gotay CC, Snyder CF. Patient-reported outcomes in cancer: a review of recent research and policy initiatives. CA Cancer J Clin. 2007 Sep-Oct;57(5):278-300. doi: 10.3322/CA.57.5.278. | |
| 9161115 | Background | Dancey J, Zee B, Osoba D, Whitehead M, Lu F, Kaizer L, Latreille J, Pater JL. Quality of life scores: an independent prognostic variable in a general population of cancer patients receiving chemotherapy. The National Cancer Institute of Canada Clinical Trials Group. Qual Life Res. 1997 Mar;6(2):151-8. doi: 10.1023/a:1026442201191. |
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| Department of Obstetrics & Gynecology, University Hospital Bonn |
| Bonn |
| 53105 |
| Germany |
| Department of Obstetrics & Gynecology, University Hospital Cologne | Cologne | 50931 | Germany |
| 17991929 | Background | Garcia SF, Cella D, Clauser SB, Flynn KE, Lad T, Lai JS, Reeve BB, Smith AW, Stone AA, Weinfurt K. Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative. J Clin Oncol. 2007 Nov 10;25(32):5106-12. doi: 10.1200/JCO.2007.12.2341. |
| 18048818 | Background | Basch E, Iasonos A, Barz A, Culkin A, Kris MG, Artz D, Fearn P, Speakman J, Farquhar R, Scher HI, McCabe M, Schrag D. Long-term toxicity monitoring via electronic patient-reported outcomes in patients receiving chemotherapy. J Clin Oncol. 2007 Dec 1;25(34):5374-80. doi: 10.1200/JCO.2007.11.2243. |
| 10871716 | Background | Taenzer P, Bultz BD, Carlson LE, Speca M, DeGagne T, Olson K, Doll R, Rosberger Z. Impact of computerized quality of life screening on physician behaviour and patient satisfaction in lung cancer outpatients. Psychooncology. 2000 May-Jun;9(3):203-13. doi: 10.1002/1099-1611(200005/06)9:33.0.co;2-y. |
| 1583942 | Background | Roizen MF, Coalson D, Hayward RS, Schmittner J, Thisted RA, Apfelbaum JL, Stocking CB, Cassel CK, Pompei P, Ford DE, et al. Can patients use an automated questionnaire to define their current health status? Med Care. 1992 May;30(5 Suppl):MS74-84. doi: 10.1097/00005650-199205001-00007. |