Tablet-based Patient Reported Outcome

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.

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Key information

Conditions

Antineoplastic Agents

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics & Gynecology, Evangelisches Krankenhaus Bergisch-Gladbach, Bergisch Gladbach, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tablet-based questionnaire

Device

tablet-based patient reported outcomes (TabPRO)

Primary outcomes

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 outcomes

Answered questionnaires per patient

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Nov 25, 2013
Registry last updated: May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed