Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2013-09-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Tablet-based reported outcome
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.
Tablet-based questionnaire
tablet-based patient reported outcomes (TabPRO)
Interventions
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Tablet-based questionnaire
tablet-based patient reported outcomes (TabPRO)
Eligibility Criteria
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Inclusion Criteria
* written consent form and agreement to participate in the study
* patients that are able to follow the study instructions and that most likely will keep the required study appointments
* patients that have a histological confirmed carcinoma and are scheduled to undergo adjuvant or neoadjuvant chemotherapy of 6 to 8 cycles
* questions about chemotherapy associated side effects are composed in german. Therefore the study participants must have sufficient knowledge of the german language
* ECOG maximal level 2
Exclusion Criteria
* patients that don't agree to take part of the study
* patients that are not able to understand the scope, the meaning and the consequences of that clinical study
* patients that have a known or constant addiction to drugs or alcohol
* patients that suffer from blindness or dyslexia
18 Years
100 Years
FEMALE
No
Sponsors
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University Hospital, Bonn
OTHER
Responsible Party
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Michael Mallmann, MD
Coordinating Investigator
Principal Investigators
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Michael Mallmann, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics & Gynecology, University Hospital Bonn
Locations
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Department of Obstetrics & Gynecology, Evangelisches Krankenhaus Bergisch-Gladbach
Bergisch Gladbach, , Germany
Department of Obstetrics & Gynecology, University Hospital Bonn
Bonn, , Germany
Department of Obstetrics & Gynecology, University Hospital Cologne
Cologne, , Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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TabPRO I
Identifier Type: -
Identifier Source: org_study_id
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