Tablet-based Patient Reported Outcome

May 22, 2016 updated by: Michael Mallmann, MD, University Hospital, Bonn

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bergisch-Gladbach, Germany
        • Department of Obstetrics & Gynecology, Evangelisches Krankenhaus Bergisch-Gladbach
      • Bonn, Germany, 53105
        • Department of Obstetrics & Gynecology, University Hospital Bonn
      • Cologne, Germany, 50931
        • Department of Obstetrics & Gynecology, University Hospital Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Tablet-based questionnaire of PRO
Time Frame: 6 months
Feasibility of Tablet-based questionnaire of PRO (>60% of patients answer >60% of questionnaires in the time frame of study duration)
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Answered questionnaires per patient
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 17, 2013

First Submitted That Met QC Criteria

November 17, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 22, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TabPRO I

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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