Oncologic Therapy Support Via Means of a Dedicated Mobile App
OPTIMISE-1
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 30, 2017
May 1, 2017
1.4 years
May 23, 2017
May 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Treatment-related patient satisfaction
12-14 weeks
Diagnosis-related Quality of Life
12-14 weeks
Study Arms (1)
Mobile application
EXPERIMENTALPatients undergoing radiotherapy will receive additional therapy support by an application installed on a mobile device
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of Radiation Oncology, University of Heidelberg, Germany
Heidelberg, 69120, Germany
Related Publications (1)
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.
PMID: 29510971DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nils Nicolay, PD Dr. Dr.
Heidelberg Institute of Radiation Oncology (HIRO)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. Dr. Nils Nicolay
Study Record Dates
First Submitted
May 23, 2017
First Posted
May 30, 2017
Study Start
July 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
May 30, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share