Tablet-based Patient Reported Outcome

Study Overview
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Brief Summary
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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.

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

Conditions
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Antineoplastic Agents

Intervention / Treatment
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* Device: Tablet-based questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tablet-based reported outcome<br>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<br>* tablet-based patient reported outcomes (TabPRO)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Tablet-based questionnaire of PRO | Feasibility of Tablet-based questionnaire of PRO (>60% of patients answer >60% of questionnaires in the time frame of study duration) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Answered questionnaires per patient |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antineoplastic Agents