Thoracic NeoplasmOPTIMISE-1NCT03168048
Oncologic Therapy Support Via Means of a Dedicated Mobile App
A study testing mobile application in people with Thoracic Neoplasm and Pelvic Neoplasm, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Neoplasm, Pelvic Neoplasm, Radiotherapy; Complications
- What is being tested?
- mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept of Radiation Oncology, University of Heidelberg, Germany
Heidelberg, 69120
About this study
Official title: Oncologic Therapy Support Via Means of a Dedicated Mobile App - a Prospective Feasibility Evaluation
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.
- Conditions
- Thoracic Neoplasm, Pelvic Neoplasm, Radiotherapy; Complications, Oncologic Disorders, Breast Cancer, Satisfaction
- Being tested
- mobile application
- Keywords
- mobile application, radiotherapy, patient-care, mhealth, follow-up, patient satisfaction, quality of life
- Medical subject headings
- Thoracic Neoplasms, Pelvic Neoplasms, Breast Neoplasms, Personal Satisfaction, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile applicationOther
Oncologic therapy support by means of a mobile application
| Study group | Role | What they receive |
|---|---|---|
| Mobile application | Experimental | Patients undergoing radiotherapy will receive additional therapy support by an application installed on a mobile device Receives: Other: mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility judged by number of questions answered by each patient on each treatment day
Feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day
Measured: 12-14 weeks
Secondary outcomes (2)
Treatment-related patient satisfaction
Treatment-related patient satisfaction will be assessed after therapy completion by means of the adapted PSQ-18 questionnaire.
Measured: 12-14 weeks
Diagnosis-related Quality of Life
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.
Measured: 12-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study startJul 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center prospective exploratory study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nils Nicolay, PD Dr. Dr., Heidelberg University
- Investigators
- Nils Nicolay, PD Dr. Dr., Principal investigator, Heidelberg Institute of Radiation Oncology (HIRO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168048
- Sponsor's protocol ID
- OPTIMISE-1
- Acronym
- OPTIMISE-1
- Status last verified
- May 2017
- First submitted
- 23 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29510971
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncologic Therapy Support Via Means of a Dedicated Mobile App - a Prospective Feasibility Evaluation
- ClinicalTrials.gov ID
- NCT03168048
- Acronym / sponsor ID
- OPTIMISE-1 / OPTIMISE-1
- Conditions
- Thoracic Neoplasm, Pelvic Neoplasm, Radiotherapy; Complications, Oncologic Disorders, Breast Cancer, Satisfaction
- Keywords
- mobile application, radiotherapy, patient-care, mhealth, follow-up, patient satisfaction, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center prospective exploratory study
| Arm | Type | Receives |
|---|---|---|
| Mobile application | Experimental | Other: mobile applicationPatients undergoing radiotherapy will receive additional therapy support by an application installed on a mobile device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile applicationOncologic therapy support by means of a mobile application | Other | Mobile application |
Primary outcome
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
2 secondary outcomes
Treatment-related patient satisfaction
Time frame: 12-14 weeks
Diagnosis-related Quality of Life
Time frame: 12-14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Derived from this study: PubMed 29510971El 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.
- Individual participant dataSharing planned: No
Related trials for Thoracic Neoplasm
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nils Nicolay, PD Dr. Dr. principal investigator
Heidelberg Institute of Radiation Oncology (HIRO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile application in people with Thoracic Neoplasm and Pelvic Neoplasm, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nils Nicolay, PD Dr. Dr. (+49 6221 56 8202, nils.nicolay@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility judged by number of questions answered by each patient on each treatment day (time frame: 12-14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03168048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.