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Tablet-based Patient Reported Outcome

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ClinicalTrials.gov Identifier: NCT01991691
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Mallmann, MD, University Hospital, Bonn

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
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 : September 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Answered questionnaires per patient [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991691


Locations
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Germany
Department of Obstetrics & Gynecology, Evangelisches Krankenhaus Bergisch-Gladbach
Bergisch-Gladbach, Germany
Department of Obstetrics & Gynecology, University Hospital Bonn
Bonn, Germany, 53105
Department of Obstetrics & Gynecology, University Hospital Cologne
Cologne, Germany, 50931
Sponsors and Collaborators
University Hospital, Bonn
Investigators
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Principal Investigator: Michael Mallmann, MD Department of Obstetrics & Gynecology, University Hospital Bonn

Publications:

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Responsible Party: Michael Mallmann, MD, Coordinating Investigator, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT01991691     History of Changes
Other Study ID Numbers: TabPRO I
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Keywords provided by Michael Mallmann, MD, University Hospital, Bonn:
Antineoplastic Agents