Oncologic Therapy Support Via Means of a Dedicated Mobile App

NCT ID: NCT03168048

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-center prospective exploratory study
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Mobile application

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

Group Type EXPERIMENTAL

mobile application

Intervention Type OTHER

Oncologic therapy support by means of a mobile application

Interventions

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mobile application

Oncologic therapy support by means of a mobile application

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Nils Nicolay, PD Dr. Dr.

PD Dr. Dr. Nils Nicolay

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nils Nicolay, PD Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg Institute of Radiation Oncology (HIRO)

Locations

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Dept of Radiation Oncology, University of Heidelberg, Germany

Heidelberg, , Germany

Site Status

Countries

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Germany

Central Contacts

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Nils Nicolay, PD Dr. Dr.

Role: CONTACT

+49 6221 56 8202

Rami A. El Shafie

Role: CONTACT

+49 6221 56 8202

References

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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.

Reference Type DERIVED
PMID: 29510971 (View on PubMed)

Other Identifiers

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OPTIMISE-1

Identifier Type: -

Identifier Source: org_study_id

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