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ISRCTN
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ISRCTN32511542
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ClinicalTrials.gov identifier
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Public title
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Physical activity level as an outcome measure for use in cancer cachexia trials: a feasibility study
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Scientific title
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Acronym
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N/A
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Serial number at source
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Version 1.1
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Study hypothesis
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Patients with lung or upper-gastrointestinal cancer will find the wearing of an activity monitor over one week acceptable. This has been defined as 80% of patients finding the device acceptable, demonstrated by them wearing the monitor 80% of the time.
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Ethics approval
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Ethics approval received from the Oxfordshire Research Ethics Committee ‘A’ Study on the 8th March 2007 (ref: 07/Q1604/16).
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Study design
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Non-randomised, unblinded single-group design
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Palliative care in cancer patients
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Participants - inclusion criteria
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1. Diagnosis of lung or upper-gastrointestinal cancer
2. Eastern Cooperative Oncology Group performance status of 0 - 2
3. Adequate understanding of verbal and written English
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Participants - exclusion criteria
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1. Currently receiving chemo-radiation therapy
2. Less than four weeks post surgery
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Anticipated start date
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01/08/2007
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Anticipated end date
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01/05/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60
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Interventions
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Use of an ActivPAL free-living activity monitor (PAL technologies, Glassgow, UK) to assess free-living activity over one week. There is no control group in this trial, the activity monitors will be used for a period of one-week and, as we are assessing acceptability as a primary endpoint, there is no follow-up beyond this period.
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Primary outcome measure(s)
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Percentage acceptability of assessing physical activity level with an ActivPAL monitor over one week in patients with lung or upper gastro-intestinal cancer.
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Secondary outcome measure(s)
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1. Correlation between the stepping component and the non-stepping component of the activity score
2. Limits of agreement between the measured stepping component of the activity score and an estimate of the stepping component based on step count; step count for each participant multiplied by the mean 'activity per step' calculated from all participants
All secondary endpoints will be assessed retrospectively, after one week, using the data uploaded from the activity monitors.
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Sources of funding
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Cancer Research UK (UK) (Ref: C18598/A8211)
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Trial website
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Publications
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Contact name
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Dr
Andrew
Wilcock
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Address
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Macmillan Reader in Palliative Medicine and Medical Oncology
University of Nottingham
Hayward House Macmillan Specialist Palliative Cancer Care Unit
Nottingham University Hospitals NHS Trust
City Hospital Campus
Hucknall Road
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City/town
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Nottingham
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Zip/Postcode
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NG5 1PB
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Country
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United Kingdom
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Tel
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+44 (0)115 962 7778
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Fax
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+44 (0)115 962 7779
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Email
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andrew.wilcock@nottingham.ac.uk
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Sponsor
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University of Nottingham (UK)
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Address
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Research Innovation Services
Kings Meadow Campus
Lenton Lane
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City/town
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Nottingham
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Zip/Postcode
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NG7 2RD
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Country
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United Kingdom
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Tel
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+44 (0)115 951 5151
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Fax
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+44 (0)115 951 3666
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Email
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paul.cartledge@nottingham.ac.uk
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Sponsor website:
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http://www.nottingham.ac.uk/
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Date applied
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05/09/2007
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Last edited
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05/12/2007
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Date ISRCTN assigned
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05/12/2007
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