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Telemonitoring of Geriatric Cancer Patients Using Handheld Devices

Sponsor
Universitätsmedizin Mannheim (Other)
Overall Status
Completed
CT.gov ID
NCT03196050
Collaborator
Hector-Stiftung (Other), humediQ global GmbH, Grünwald (Other), Vitaphone GmbH, Mannheim (Other)
50
Enrollment
1
Location
1
Arm
25
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Handheld Device (Smart Phone)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Telemonitoring of Geriatric Cancer Patients Using Handheld Devices (TeleGraPH)
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telemonitoring using a handheld device

Patients will be euqipped with either an app or a handheld device with a pre-installed app to communicate with the coordinating center.

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

Outcome Measures

Primary Outcome Measures

  1. Device Adherence/Compliance [1 Year]

    Frequency of using the handheld device and of daily/weekly/monthly reportings

Secondary Outcome Measures

  1. Quality of Life [1 Year]

    Assessed using the EORTC QLQ-C30 questionnaire

  2. Reliability of reports [1 Year]

    Patient-reported status will be compared to physician-rated status

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Radiotherapy University Hospital Mannheim Mannheim Germany 68167

Sponsors and Collaborators

  • Universitätsmedizin Mannheim
  • Hector-Stiftung
  • humediQ global GmbH, Grünwald
  • Vitaphone GmbH, Mannheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Frederik Wenz, Director and Chief Medical Officer, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier:
NCT03196050
Other Study ID Numbers:
  • TeleGraPH
First Posted:
Jun 22, 2017
Last Update Posted:
Jan 23, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 23, 2019