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

Sponsor

Heidelberg University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03168048

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single-center prospective exploratory studySingle-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

Anticipated Study Start Date :

Jul 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Feasibility judged by number of questions answered by each patient on each treatment day [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

Treatment-related patient satisfaction [12-14 weeks]
Treatment-related patient satisfaction will be assessed after therapy completion by means of the adapted PSQ-18 questionnaire.
Diagnosis-related Quality of Life [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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