Telemonitoring of Geriatric Cancer Patients Using Handheld Devices
1 other identifier
interventional
50
1 country
1
Brief Summary
Cancer is becoming a chronic disease, with the requirement of a lifelong intake of cancer-controlling drugs. While young(er) patients may cope with this, geriatric cancer patients may require a more customized and tailored follow up. Most elderly patients have multiple other diseases ("comorbidities") and, due to many other factors, may per se not tolerate or simply not follow anticancer therapies. This may not only impair quality of life (QoL), but on the long rung also the therapeutic outcome (survival). Handheld devices provide a new reporting/communication tool for patients and health care providers. TeleGraPH will assess if these devices are a suitable communication modality in a cohort of geriatric cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJanuary 23, 2019
January 1, 2019
2.1 years
June 20, 2017
January 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Device Adherence/Compliance
Frequency of using the handheld device and of daily/weekly/monthly reportings
1 Year
Secondary Outcomes (2)
Quality of Life
1 Year
Reliability of reports
1 Year
Study Arms (1)
Telemonitoring using a handheld device
EXPERIMENTALPatients will be euqipped with either an app or a handheld device with a pre-installed app to communicate with the coordinating center.
Interventions
Handheld device will be used for 3 tasks: 1x per day: status update ("how are you today"?) 1x per week: 10 questions on general health status 1x per month: EORTC QLQ-C30 questionnaire
Eligibility Criteria
You may qualify if:
- Age \> 60 years
- Karnofsky Performance Status ≥ 70
- histologically confirmed malignant tumor (cancer)
You may not qualify if:
- concurrent severe and/or uncontrolled concomitant medical conditions
- Patients unwilling or unable to comply with using a handheld device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitätsmedizin Mannheimlead
- Hector-Stiftungcollaborator
- humediQ global GmbH, Grünwaldcollaborator
- Vitaphone GmbH, Mannheimcollaborator
Study Sites (1)
Department of Radiotherapy University Hospital Mannheim
Mannheim, 68167, Germany
Related Publications (1)
Buergy D, Siefert V, Neumaier C, Ganslandt T, Sperk E, Blessing M, Hesser J, Welzel G, Wenz F, Giordano FA. Prospective trial on telemonitoring of geriatric cancer patients using handheld devices. Strahlenther Onkol. 2020 Mar;196(3):205-212. doi: 10.1007/s00066-019-01548-0. Epub 2019 Nov 18.
PMID: 31740981DERIVED
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director and Chief Medical Officer
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 22, 2017
Study Start
November 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
January 23, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share