Oncologic Therapy Support Via Means of a Dedicated Mobile App

Not Applicable

• Conditions: Oncologic Disorders; Satisfaction; Radiotherapy; Complications; Quality of Life; Thoracic Neoplasm; Pelvic Neoplasm; Breast Cancer
• Interventions: Other: mobile application

• Registration Number: NCT03168048
• Lead Sponsor: Heidelberg University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-24
• Last Update Submitted: 2017-05-24
• Study First Posted: 2017-05-30
• Last Update Posted: 2017-05-30
• Study Start: 2017-07
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mobile application	mobile application	Patients undergoing radiotherapy will receive additional therapy support by an application installed on a mobile device

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Treatment-related patient satisfaction	12-14 weeks	Treatment-related patient satisfaction will be assessed after therapy completion by means of the adapted PSQ-18 questionnaire.
Diagnosis-related Quality of Life	12-14 weeks	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.

Trial Locations

Locations (1)

Dept of Radiation Oncology, University of Heidelberg, Germany; 🇩🇪 Heidelberg, Germany