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

H

Heidelberg University

Status

Unknown

Conditions

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

Treatments

Other: mobile application

Study type

Interventional

Funder types

Other

Identifiers

NCT03168048
OPTIMISE-1

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Mobile application
Experimental group
Description:
Patients undergoing radiotherapy will receive additional therapy support by an application installed on a mobile device
Treatment:
Other: mobile application

Trial contacts and locations

1

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Central trial contact

Rami A. El Shafie; Nils Nicolay, PD Dr. Dr.

Data sourced from clinicaltrials.gov

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