Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03168048
Recruitment Status : Unknown
Verified May 2017 by Nils Nicolay, PD Dr. Dr., Heidelberg University.
Recruitment status was:  Not yet recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Nils Nicolay, PD Dr. Dr., 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.

Condition or disease Intervention/treatment Phase
Thoracic Neoplasm Pelvic Neoplasm Radiotherapy; Complications Oncologic Disorders Breast Cancer Satisfaction Quality of Life Other: mobile application Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single-center prospective exploratory study
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Oncologic Therapy Support Via Means of a Dedicated Mobile App - a Prospective Feasibility Evaluation
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Mobile application
Patients undergoing radiotherapy will receive additional therapy support by an application installed on a mobile device
Other: mobile application
Oncologic therapy support by means of a mobile application




Primary Outcome Measures :
  1. Feasibility judged by number of questions answered by each patient on each treatment day [ Time Frame: 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 :
  1. Treatment-related patient satisfaction [ Time Frame: 12-14 weeks ]
    Treatment-related patient satisfaction will be assessed after therapy completion by means of the adapted PSQ-18 questionnaire.

  2. Diagnosis-related Quality of Life [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168048


Contacts
Layout table for location contacts
Contact: Nils Nicolay, PD Dr. Dr. +49 6221 56 8202 nils.nicolay@med.uni-heidelberg.de
Contact: Rami A. El Shafie +49 6221 56 8202 rami.elshafie@med.uni-heidelberg.de

Locations
Layout table for location information
Germany
Dept of Radiation Oncology, University of Heidelberg, Germany
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Layout table for investigator information
Principal Investigator: Nils Nicolay, PD Dr. Dr. Heidelberg Institute of Radiation Oncology (HIRO)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nils Nicolay, PD Dr. Dr., PD Dr. Dr. Nils Nicolay, Heidelberg University
ClinicalTrials.gov Identifier: NCT03168048     History of Changes
Other Study ID Numbers: OPTIMISE-1
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nils Nicolay, PD Dr. Dr., Heidelberg University:
mobile application
radiotherapy
patient-care
mhealth
follow-up
patient satisfaction
quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Thoracic Neoplasms
Pelvic Neoplasms
Neoplasms
Neoplasms by Site