Oncologic Therapy Support Via Means of a Dedicated Mobile App

Study Overview
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Brief Summary
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The present single-center prospective exploratory study, conducted at Heidelberg University Hospital, assesses the feasibility of introducing a concept for additional patient care based on a mobile application for patients undergoing radiotherapy. Patients presenting themselves for the irradiation of thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related Quality of Life (QoL) and symptoms and their need to personally consult a physician on a treatment-daily basis by means of a mobile application. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and diagnosis-related QoL is assessed by PSQ-18 and EORTC questionnaires at the end of radiotherapy and at the first follow-up.

Official Title
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Oncologic Therapy Support Via Means of a Dedicated Mobile App - a Prospective Feasibility Evaluation

Conditions
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Thoracic Neoplasm, Pelvic Neoplasm, Radiotherapy; Complications, Oncologic Disorders, Breast Cancer, Satisfaction, Quality of Life

Intervention / Treatment
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* Other: mobile application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for radiotherapy with potentially curative intent of a primarily thoracic or pelvic target Karnofsky performance score (KPS) ≥ 70%, Ability to initiate the therapy as an outpatient ≥ 18 years of age Exclusion Criteria: Inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Single-center prospective exploratory study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile application<br>Patients undergoing radiotherapy will receive additional therapy support by an application installed on a mobile device | Other: mobile application<br>* Oncologic therapy support by means of a mobile application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility judged by number of questions answered by each patient on each treatment day | Feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day | 12-14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related patient satisfaction | Treatment-related patient satisfaction will be assessed after therapy completion by means of the adapted PSQ-18 questionnaire. | 12-14 weeks | 
| Diagnosis-related Quality of Life | Quality of Life will be assessed at before the start and after the completion of radiotherapy, as well as at first follow-up by means of the EORTC QLQ-C30 questionnaire and the respective diagnosis-related questionnaire modules. | 12-14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile application, radiotherapy, patient-care, mhealth, follow-up, patient satisfaction, quality of life