Tablet-based Patient Reported Outcome

• Sponsor: University Hospital, Bonn (Other)
• Overall Status: Completed
• CT.gov ID: NCT01991691
• Collaborator: (none)
• Enrollment: 57
• Locations: 3
• Arm: 1
• Duration (Months): 27
• Patients Per Site: 19
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antineoplastic Agents	Device: Tablet-based questionnaire	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Pilot Study for Tablet-based Questionnaire of Patient-reported Outcomes From Patients Undergoing Chemotherapy (TabPRO I)
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Tablet-based questionnaire; tablet-based patient reported outcomes (TabPRO)

Outcome Measures

Primary Outcome Measures

1. Feasibility of Tablet-based questionnaire of PRO [6 months]

   Feasibility of Tablet-based questionnaire of PRO (>60% of patients answer >60% of questionnaires in the time frame of study duration)

Secondary Outcome Measures

1. Answered questionnaires per patient [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics & Gynecology, Evangelisches Krankenhaus Bergisch-Gladbach	Bergisch-Gladbach		Germany
2	Department of Obstetrics & Gynecology, University Hospital Bonn	Bonn		Germany	53105
3	Department of Obstetrics & Gynecology, University Hospital Cologne	Cologne		Germany	50931

Sponsors and Collaborators

• University Hospital, Bonn

Investigators

• Principal Investigator: Michael Mallmann, MD, Department of Obstetrics & Gynecology, University Hospital Bonn

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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].
• 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.
• 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.
• 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.

• Responsible Party: Michael Mallmann, MD, Coordinating Investigator, University Hospital, Bonn
• ClinicalTrials.gov Identifier: NCT01991691
• Other Study ID Numbers: TabPRO I
• First Posted: Nov 25, 2013
• Last Update Posted: May 24, 2016
• Last Verified: May 1, 2016

• Keywords provided by Michael Mallmann, MD, Coordinating Investigator, University Hospital, Bonn: Antineoplastic Agents

Study Results

No Results Posted as of May 24, 2016