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Tablet-based Patient Reported Outcome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01991691
Enrollment
57
Registered
2013-11-25
Start date
2013-09-30
Completion date
2015-12-31
Last updated
2016-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antineoplastic Agents

Keywords

Antineoplastic Agents

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.

Interventions

DEVICETablet-based questionnaire

tablet-based patient reported outcomes (TabPRO)

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 100 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Tablet-based questionnaire of PRO6 monthsFeasibility of Tablet-based questionnaire of PRO (\>60% of patients answer \>60% of questionnaires in the time frame of study duration)

Secondary

MeasureTime frame
Answered questionnaires per patient6 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026