Oncologic Therapy Support Via Means of a Dedicated Mobile App

Breast Cancer Clinical Trial

— OPTIMISE-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03168048
• Other study ID #: OPTIMISE-1
• Status: Not yet recruiting
• Phase: N/A
• First received: May 23, 2017
• Last updated: May 24, 2017
• Start date: July 2017
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: Heidelberg University
• Contact: Nils Nicolay, PD Dr. Dr.
• Phone: +49 6221 56 8202
• Email: nils.nicolay[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Neoplasms
• Oncologic Disorders
• Pelvic Neoplasm
• Pelvic Neoplasms
• Quality of Life
• Radiotherapy; Complications
• Satisfaction
• Thoracic Neoplasm
• Thoracic Neoplasms

Intervention

Other:
• mobile application
Oncologic therapy support by means of a mobile application

Locations

Country	Name	City	State
Germany	Dept of Radiation Oncology, University of Heidelberg, Germany	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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