Clinical trial NCT01991691: Tablet-based Patient Reported Outcome
Official title: Pilot Study for Tablet-based Questionnaire of Patient-reported Outcomes From Patients Undergoing Chemotherapy (TabPRO I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antineoplastic Agents
Keywords: Antineoplastic Agents
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* patients have to be ≥ 18 years of age
* 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 are younger than 18 years
* 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

Primary outcomes:
measure: Feasibility of Tablet-based questionnaire of PRO
timeFrame: 6 months
Secondary outcomes:
measure: Answered questionnaires per patient
timeFrame: 6 months
Other outcomes:
Locations:
city: Bergisch-Gladbach
country: Germany
facility: Department of Obstetrics & Gynecology, Evangelisches Krankenhaus Bergisch-Gladbach
city: Bonn
country: Germany
facility: Department of Obstetrics & Gynecology, University Hospital Bonn
city: Cologne
country: Germany
facility: Department of Obstetrics & Gynecology, University Hospital Cologne
Study officials:
affiliation: Department of Obstetrics & Gynecology, University Hospital Bonn
name: Michael Mallmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.