Tablet-based Patient Reported Outcome

Not Applicable

Completed

• Conditions: Antineoplastic Agents

• Registration Number: NCT01991691
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-17
• Study First Submitted QC: 2013-11-17
• Study First Posted: 2013-11-25
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-22
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Answered questionnaires per patient	6 months

Trial Locations

Locations (3)

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, Germany