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NCT03196050 Clinical Trial

Telemonitoring of Geriatric Cancer Patients Using Handheld Devices

Cancer Clinical Trial

Official title:
Telemonitoring of Geriatric Cancer Patients Using Handheld Devices (TeleGraPH)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03196050
Other study ID # TeleGraPH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date December 2018

Study information
Verified date January 2019
Source Universitätsmedizin Mannheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Age > 60 years

- Karnofsky Performance Status = 70

- histologically confirmed malignant tumor (cancer)

Exclusion Criteria:

- concurrent severe and/or uncontrolled concomitant medical conditions

- Patients unwilling or unable to comply with using a handheld device

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Handheld Device (Smart Phone)
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

Locations
Country Name City State
Germany Department of Radiotherapy University Hospital Mannheim Mannheim

Sponsors (4)
Lead Sponsor Collaborator
Universitätsmedizin Mannheim Hector-Stiftung, humediQ global GmbH, Grünwald, Vitaphone GmbH, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Device Adherence/Compliance Frequency of using the handheld device and of daily/weekly/monthly reportings 1 Year
Secondary Quality of Life Assessed using the EORTC QLQ-C30 questionnaire 1 Year
Secondary Reliability of reports Patient-reported status will be compared to physician-rated status 1 Year
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