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Oncologic Therapy Support Via Means of a Dedicated Mobile App

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03168048
Acronym
OPTIMISE-1
Enrollment
50
Registered
2017-05-30
Start date
2017-07-31
Completion date
2018-12-31
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

mobile application, radiotherapy, patient-care, mhealth, follow-up, patient satisfaction, quality of life

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.

Interventions

OTHERmobile application

Oncologic therapy support by means of a mobile application

Sponsors

Heidelberg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention model description

Single-center prospective exploratory study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility judged by number of questions answered by each patient on each treatment day12-14 weeksFeasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day

Secondary

MeasureTime frameDescription
Treatment-related patient satisfaction12-14 weeksTreatment-related patient satisfaction will be assessed after therapy completion by means of the adapted PSQ-18 questionnaire.
Diagnosis-related Quality of Life12-14 weeksQuality 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.

Countries

Germany

Contacts

Primary ContactNils Nicolay, PD Dr. Dr.
nils.nicolay@med.uni-heidelberg.de+49 6221 56 8202
Backup ContactRami A. El Shafie
rami.elshafie@med.uni-heidelberg.de+49 6221 56 8202

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026