CancerNCT03196050
Telemonitoring of Geriatric Cancer Patients Using Handheld Devices
A study testing Handheld Device (Smart Phone) in people with Cancer, run by Universitätsmedizin Mannheim at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Handheld Device (Smart Phone)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 60 years
- Karnofsky Performance Status ≥ 70
- histologically confirmed malignant tumor (cancer)
Who cannot join
- concurrent severe and/or uncontrolled concomitant medical conditions
- Patients unwilling or unable to comply with using a handheld device
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Radiotherapy University Hospital Mannheim
Mannheim, 68167
About this study
Official title: Telemonitoring of Geriatric Cancer Patients Using Handheld Devices (TeleGraPH)
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.
- Conditions
- Cancer
- Being tested
- Handheld Device (Smart Phone)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handheld Device (Smart Phone)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring using a handheld device | Experimental | Patients will be euqipped with either an app or a handheld device with a pre-installed app to communicate with the coordinating center. Receives: Device: Handheld Device (Smart Phone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Adherence/Compliance
Frequency of using the handheld device and of daily/weekly/monthly reportings
Measured: 1 Year
Secondary outcomes (2)
Quality of Life
Assessed using the EORTC QLQ-C30 questionnaire
Measured: 1 Year
Reliability of reports
Patient-reported status will be compared to physician-rated status
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study startNov 2016
- Primary completionDec 2018
- Study completionDec 2018
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 CancerStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- Hector-Stiftung, humediQ global GmbH, Grünwald, Vitaphone GmbH, Mannheim
- Responsible party
- Principal investigator, Frederik Wenz, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196050
- Sponsor's protocol ID
- TeleGraPH
- Status last verified
- Jan 2019
- First submitted
- 20 Jun 2017
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31740981
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitoring of Geriatric Cancer Patients Using Handheld Devices (TeleGraPH)
- ClinicalTrials.gov ID
- NCT03196050
- Acronym / sponsor ID
- TeleGraPH
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Collaborators
- Hector-Stiftung, humediQ global GmbH, Grünwald, Vitaphone GmbH, Mannheim
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 22 Jun 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring using a handheld device | Experimental | Device: Handheld Device (Smart Phone)Patients will be euqipped with either an app or a handheld device with a pre-installed app to communicate with the coordinating center. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 60 years
- Karnofsky Performance Status ≥ 70
- histologically confirmed malignant tumor (cancer)
Key exclusion criteria (2 listed)
- concurrent severe and/or uncontrolled concomitant medical conditions
- Patients unwilling or unable to comply with using a handheld device
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 |
|---|---|---|
| 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 | Device | Telemonitoring using a handheld device |
Primary outcome
Device Adherence/Compliance
Time frame: 1 Year
Frequency of using the handheld device and of daily/weekly/monthly reportings
2 secondary outcomes
Quality of Life
Time frame: 1 Year
Reliability of reports
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Derived from this study: PubMed 31740981Buergy 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handheld Device (Smart Phone) in people with Cancer, run by Universitätsmedizin Mannheim 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 23 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Adherence/Compliance (time frame: 1 Year). 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 NCT03196050, 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 23 Jan 2019.