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Clinical Trials/NCT03168048
NCT03168048UnknownNot Applicable

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

Heidelberg University1 site in 1 country50 target enrollmentStarted: July 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
1
Primary Endpoint
Feasibility judged by number of questions answered by each patient on each treatment day

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Mobile application

Experimental

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

Intervention: mobile application (Other)

Outcomes

Primary Outcomes

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 Outcomes

  • Treatment-related patient satisfaction(12-14 weeks)
  • Diagnosis-related Quality of Life(12-14 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nils Nicolay, PD Dr. Dr.

PD Dr. Dr. Nils Nicolay

Heidelberg University

Study Sites (1)

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