Tablet-based Patient Reported Outcome

Antineoplastic Agents Clinical Trial

Official title:

Pilot Study for Tablet-based Questionnaire of Patient-reported Outcomes From Patients Undergoing Chemotherapy (TabPRO I)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991691
• Other study ID #: TabPRO I
• Status: Completed
• Phase: N/A
• First received: November 17, 2013
• Last updated: May 22, 2016
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Antineoplastic Agents

Intervention

Device:
• Tablet-based questionnaire
tablet-based patient reported outcomes (TabPRO)

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View 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. — View 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. Review. Erratum in: J Clin Oncol. 2008 Feb 20;26(6):1018. Lad, Thomas [added]. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Answered questionnaires per patient		6 months	No