NCT Mobile - Smartphone-Based Video Consultations in Medical Oncology
Organizational Data
- DRKS-ID:
- DRKS00015788
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2018-10-26
- Last update in DRKS:
- 2021-01-11
- Registration type:
- Retrospective
Acronym/abbreviation of the study
NCT-MOBILE
URL of the study
No Entry
Brief summary in lay language
The NCT-MOBILE trial will compare patient-physician consultations via a dedicated video consultation smartphone application with in-person office consultations in oncological patients.
Brief summary in scientific language
The NCT-MOBILE trial is a single center randomized open label clinical trial to evaluate feasibility of patient-physician video consultations in oncological outpatients with solid tumors. After initiation of a cancer specific therapy 66 patients will be randomly assigned, in a 1:1 ratio, to receive video consultations via a dedicated smartphone application or in-person consultation at the outpatient clinic. Primary endpoint is the rate of successful patient-physician consultations at the first planned visit 2-14 days after initiation of a cancer specific therapy.
Health condition or problem studied
- Free text:
- solid malignant tumors (ICD-10 C00-C80)
- ICD10:
- C00-C75 - Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue
- ICD10:
- C76-C80 - Malignant neoplasms of ill-defined, secondary and unspecified sites
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- After initiation of a cancer specific therapy (oral or intravenous), patients receive a follow-up video call consultation within 2-14 days via a dedicated smartphone application (Focus Health, Minxli Ltd.). Up to 6 months after randomization patients can receive additional physician consultations within the NCT MOBILE trial. These consultation can be either in-person or via video call depending on the preferences of the patient and the treating physician.
- Arm 2:
- After initiation of a cancer specific therapy (oral or intravenous), patients receive a follow-up in-person consultation within 2-14 days at the outpatient clinic. Up to 6 months after randomization patients can receive additional physician consultations within the NCT MOBILE trial. These consultations have to be in-person at the outpatient clinic.
Endpoints
- Primary outcome:
- Feasibility (Rate of successful patient-physician consultations at first planned visit 2-14 days after initiation of a systemic cancer therapy)
- Secondary outcome:
- Time efficiency (for patient and physician) Patient satisfaction with physician-patient interaction; Patient overall satisfaction with video consultations
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center National Center for Tumor Diseases (NCT) Heidelberg Heidelberg
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2017-11-29
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2020-04-10
- Target Sample Size:
- 60
- Final Sample Size:
- 65
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Patients: Outpatients with solid tumors (main diagnosis: C00-C80 ICD-10-GM); planned follow-up visit within 2-14 days; patient has a smartphone; written informed consent for study participation; patient agrees with terms and conditions of the "Focus Health" application (Minxli Ltd.); ECOG 0-2. Physicians: Medical oncologist of the National Center for Tumor Diseases (NCT) Heidelberg, Germany; consent to participate; physician has a smartphone.
Exclusion Criteria
Age <18 years; not German speaking; severe visual or auditory impairment.
Addresses
Primary Sponsor
- Address:
- National Center for Tumor Diseases (NCT) HeidelbergIm Neuenheimer Feld 46069120 HeidelbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.nct-heidelberg.de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- National Center for Tumor Diseases (NCT) HeidelbergThomas WalleIm Neuenheimer Feld 46069120 HeidelbergGermany
- Telephone:
- 004962215632846
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.nct-heidelberg.de/
Contact for Public Queries
- Address:
- National Center for Tumor Diseases (NCT) HeidelbergThomas WalleIm Neuenheimer Feld 46069120 HeidelbergGermany
- Telephone:
- 004962215632846
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.nct-heidelberg.de/
Principal Investigator
- Address:
- National Center for Tumor Diseases (NCT) HeidelbergThomas WalleIm Neuenheimer Feld 46069120 HeidelbergGermany
- Telephone:
- 004962215632846
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.nct-heidelberg.de/
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Minxli Services UGPrannerstrasse 1080333 MünchenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://minxli.com
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- National Center for Tumor Diseases (NCT) Heidelberg Department of Medical OncologyIm Neuenheimer Feld 46069120 HeidelbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät HeidelbergAlte Glockengießerei 11/169115 HeidelbergGermany
- Telephone:
- +49-6221-338220
- Fax:
- +49-6221-3382222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-02-17
- Ethics committee number:
- S-090/2017
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-03-27
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- To provide individual anonymized patient data approval from the ethics committee I at Medical Faculty of Heidelberg University is mandatory: Ethics Commission I Alte Glockengießerei 11/1 69115 Heidelberg - Germany Tel.: 06221 562646-0 Fax: 06221 562648-0 ethikkommission-I@med.uni-heidelberg.de
Study protocol and other study documents
- Study protocols:
- Study Protocol
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- publication of trial results in ESMO Open
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry