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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile application | Experimental | Patients undergoing radiotherapy will receive additional therapy support by an application installed on a mobile device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile application | Other | Oncologic therapy support by means of a mobile application |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nils Nicolay, PD Dr. Dr. | Contact | +49 6221 56 8202 | nils.nicolay@med.uni-heidelberg.de | |
| Rami A. El Shafie | Contact | +49 6221 56 8202 | rami.elshafie@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Nils Nicolay, PD Dr. Dr. | Heidelberg Institute of Radiation Oncology (HIRO) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Radiation Oncology, University of Heidelberg, Germany | Heidelberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29510971 | Derived | El Shafie RA, Bougatf N, Sprave T, Weber D, Oetzel D, Machmer T, Huber PE, Debus J, Nicolay NH. Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial. JMIR Res Protoc. 2018 Mar 6;7(3):e70. doi: 10.2196/resprot.8915. |
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| ID | Term |
|---|---|
| D013899 | Thoracic Neoplasms |
| D010386 | Pelvic Neoplasms |
| D001943 | Breast Neoplasms |
| D010549 | Personal Satisfaction |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Single-center prospective exploratory study
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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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |