NCT03038841

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 25, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

June 21, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

January 25, 2017

Last Update Submit

June 20, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility (time of complete data transfer in weeks)

    time of complete data transfer in weeks

    12 weeks

Interventions

Patients discharged from hospital will be equipped with a tracking bracelet and a smart phone

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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)

You may not qualify if:

  • relevant cognitive impairment
  • insufficient knowledge of German language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Radiation-Oncology University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Neoplasm MetastasisChronic Disease

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Matthias Guckenberger, Prof

    Clinic of Radiation-Oncology USZ

    STUDY CHAIR
  • Gerhard Tröster, Prof

    ETH Zürich

    STUDY CHAIR
  • Gudrun Theile, MD

    Clinic of Radiation-Oncology USZ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gudrun Theile, MD

CONTACT

Matea Pavic, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2017

First Posted

February 1, 2017

Study Start

February 1, 2017

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

June 21, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations