Metastatic CancerNCT03038841
Mobile Health Technology for Palliative Care Patients
An observational study of Metastatic Cancer and Mobile Health, run by University of Zurich at 1 site in Switzerland.
Trial summary
To test the potential and acceptance of wireless activity tracking in palliative care patients leaving hospital care. Explorative study, collaboration project of the Clinic of Radiation-Oncology, University Hospital Zurich and the Wearable Computing Laboratory, Swiss Federal Institut of Technology. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Metastatic Cancer, Mobile Health, Chronic Disease
- What is being tested?
- Mobile Health
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2017to 31 May 2018
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- 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 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized at one of the wards of the Clinic of Radiation-Oncology University Hospital Zurich, including a ward of specialized Palliative Care
Who may be able to join
- established diagnosis of metastatic cancer or other severe illness with limited life-expectancy (physicians guess <12 months, > 8 weeks)
- Karnofsky Index ≥50%
- ECOG≤ 2
- aged > 18 years
- passed a short handling test with devices (tracking bracelet, smart phone)
Who cannot join
- relevant cognitive impairment
- insufficient knowledge of German language.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Clinic of Radiation-Oncology University Hospital Zurich
Zurich, Canton of Zurich, 8091
Gudrun Theile, MD, +41 44 255 5495, gudrun.theile@usz.ch
Matea Pavic, MD, +41 44 255 3015, matea.pavic@usz.ch
About this study
Official title: Mobile Health Technologies for Palliative Care Patients at the Interface of In-patient to Out-patient Care: A Feasibility Study Aiming to Early Predict Deterioration of Patient's Health Status
To test the potential and acceptance of wireless activity tracking in palliative care patients leaving hospital care. Explorative study, collaboration project of the Clinic of Radiation-Oncology, University Hospital Zurich and the Wearable Computing Laboratory, Swiss Federal Institut of Technology. Patients receive a tracking bracelet and a smart phone in order to gather objective physical activity parameters as step count, sleep duration, heart rate, social activity patterns (e.g. making calls) as well as subjective ratings of pain and distress. Quality of life (QoL) will be captured by paper questionnaire. Correlations between patients' physical activity patterns and the pain and distress level assessed from electronic scales as well as QoL-questionnaire will be performed. Acceptance will be evaluated by quantitative questionnaires and interviews. The proposed study is meant to be preparatory work for an intervention study to test the effect of wireless monitoring of palliative care patients on fostering early interventions for symptom relief and support of QoL.
- Conditions
- Metastatic Cancer, Mobile Health, Chronic Disease
- Being tested
- Mobile Health
- Medical subject headings
- Neoplasm Metastasis, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile HealthDevice
Patients discharged from hospital will be equipped with a tracking bracelet and a smart phone
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (time of complete data transfer in weeks)
time of complete data transfer in weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion31 May 2018 (estimated)
- Study completion31 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, Swiss Academy of Medical Sciences (SAMS)
- Responsible party
- Sponsor
- Investigators
- Matthias Guckenberger, Prof, Study chair, Clinic of Radiation-Oncology USZGerhard Tröster, Prof, Study chair, ETH ZürichGudrun Theile, MD, Principal investigator, Clinic of Radiation-Oncology USZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038841
- Sponsor's protocol ID
- PC 16/16
- Status last verified
- Jan 2017
- First submitted
- 25 Jan 2017
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Technologies for Palliative Care Patients at the Interface of In-patient to Out-patient Care: A Feasibility Study Aiming to Early Predict Deterioration of Patient's Health Status
- ClinicalTrials.gov ID
- NCT03038841
- Acronym / sponsor ID
- PC 16/16
- Conditions
- Metastatic Cancer, Mobile Health, Chronic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, Swiss Academy of Medical Sciences (SAMS)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 31 May 2018 (estimated)
- First posted
- 1 Feb 2017 (estimated)
- 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.
To test the potential and acceptance of wireless activity tracking in palliative care patients leaving hospital care. Explorative study, collaboration project of the Clinic of Radiation-Oncology, University Hospital Zurich and the Wearable Computing Laboratory, Swiss Federal Institut of Technology. Patients receive a tracking bracelet and a smart phone in order to gather objective physical activity parameters as step count, sleep duration, heart rate, social activity patterns (e.g. making calls) as well as subjective ratings of pain and distress. Quality of life (QoL) will be captured by paper questionnaire. Correlations between patients' physical activity patterns and the pain and distress level assessed from electronic scales as well as QoL-questionnaire will be performed. Acceptance will be evaluated by quantitative questionnaires and interviews. The proposed study is meant to be preparatory work for an intervention study to test the effect of wireless monitoring of palliative care patients on fostering early interventions for symptom relief and support of QoL.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized at one of the wards of the Clinic of Radiation-Oncology University Hospital Zurich, including a ward of specialized Palliative Care
Key inclusion criteria (5 listed)
- established diagnosis of metastatic cancer or other severe illness with limited life-expectancy (physicians guess <12 months, > 8 weeks)
- Karnofsky Index ≥50%
- ECOG≤ 2
- aged > 18 years
- passed a short handling test with devices (tracking bracelet, smart phone)
Key exclusion criteria (2 listed)
- relevant cognitive impairment
- insufficient knowledge of German language.
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 |
|---|---|---|
| Mobile HealthPatients discharged from hospital will be equipped with a tracking bracelet and a smart phone | Device | – |
Primary outcome
Feasibility (time of complete data transfer in weeks)
Time frame: 12 weeks
time of complete data transfer in weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Metastatic Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
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.
Matthias Guckenberger, Prof study chair
Clinic of Radiation-Oncology USZ
Gerhard Tröster, Prof study chair
ETH Zürich
Gudrun Theile, MD principal investigator
Clinic of Radiation-Oncology USZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer and Mobile Health, run by University of Zurich at 1 site in Switzerland.
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 5 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: status not confirmed, as of the sponsor's last update on 21 Jun 2017. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gudrun Theile, MD (+41 44 255 5495, gudrun.theile@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time of complete data transfer in weeks) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2017.