Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1)
Primary Purpose
Thoracic Neoplasm, Pelvic Neoplasm, Radiotherapy; Complications
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
mobile application
Sponsored by
About this trial
This is an interventional device feasibility trial for Thoracic Neoplasm focused on measuring mobile application, radiotherapy, patient-care, mhealth, follow-up, patient satisfaction, quality of life
Eligibility Criteria
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
Sites / Locations
- Dept of Radiation Oncology, University of Heidelberg, Germany
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobile application
Arm Description
Patients undergoing radiotherapy will receive additional therapy support by an application installed on a mobile device
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Treatment-related patient satisfaction
Treatment-related patient satisfaction will be assessed after therapy completion by means of the adapted PSQ-18 questionnaire.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03168048
Brief Title
Oncologic Therapy Support Via Means of a Dedicated Mobile App
Acronym
OPTIMISE-1
Official Title
Oncologic Therapy Support Via Means of a Dedicated Mobile App - a Prospective Feasibility Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2017 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Neoplasm, Pelvic Neoplasm, Radiotherapy; Complications, Oncologic Disorders, Breast Cancer, Satisfaction, Quality of Life
Keywords
mobile application, radiotherapy, patient-care, mhealth, follow-up, patient satisfaction, quality of life
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-center prospective exploratory study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mobile application
Arm Type
Experimental
Arm Description
Patients undergoing radiotherapy will receive additional therapy support by an application installed on a mobile device
Intervention Type
Other
Intervention Name(s)
mobile application
Intervention Description
Oncologic therapy support by means of a mobile application
Primary Outcome Measure Information:
Title
Feasibility judged by number of questions answered by each patient on each treatment day
Description
Feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day
Time Frame
12-14 weeks
Secondary Outcome Measure Information:
Title
Treatment-related patient satisfaction
Description
Treatment-related patient satisfaction will be assessed after therapy completion by means of the adapted PSQ-18 questionnaire.
Time Frame
12-14 weeks
Title
Diagnosis-related Quality of Life
Description
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.
Time Frame
12-14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nils Nicolay, PD Dr. Dr.
Phone
+49 6221 56 8202
Email
nils.nicolay@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Rami A. El Shafie
Phone
+49 6221 56 8202
Email
rami.elshafie@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Nicolay, PD Dr. Dr.
Organizational Affiliation
Heidelberg Institute of Radiation Oncology (HIRO)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Radiation Oncology, University of Heidelberg, Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29510971
Citation
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.
Results Reference
derived
Learn more about this trial
Oncologic Therapy Support Via Means of a Dedicated Mobile App
We'll reach out to this number within 24 hrs