Tablet-based Patient Reported Outcome

University Hospital Bonn (UKB)

Status: Completed

Conditions: Antineoplastic Agents

Treatments: Device: Tablet-based questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT01991691

TabPRO I

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Tablet-based reported outcome

Experimental group

Description:

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.

Treatment:

Device: Tablet-based questionnaire