Physical activity level as an outcome measure for use in cancer cachexia trials: a feasibility study

ISRCTN	ISRCTN32511542
DOI	https://doi.org/10.1186/ISRCTN32511542
Secondary identifying numbers	Version 1.1

Submission date: 05/09/2007
Registration date: 05/12/2007
Last edited: 17/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andrew Wilcock
Scientific

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
Nottingham
NG5 1PB
United Kingdom

Phone	+44 (0)115 962 7778
Email	andrew.wilcock@nottingham.ac.uk

Study information

Study design	Non-randomised, unblinded single-group design
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	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.
Ethics approval(s)	Ethics approval received from the Oxfordshire Research Ethics Committee A Study on the 8th March 2007 (ref: 07/Q1604/16).
Health condition(s) or problem(s) studied	Palliative care in cancer patients
Intervention	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.
Intervention type	Other
Primary outcome measure	Percentage acceptability of assessing physical activity level with an ActivPAL monitor over one week in patients with lung or upper gastro-intestinal cancer.
Secondary outcome measures	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.
Overall study start date	01/08/2007
Completion date	01/05/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	60
Key inclusion criteria	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
Key exclusion criteria	1. Currently receiving chemo-radiation therapy 2. Less than four weeks post surgery
Date of first enrolment	01/08/2007
Date of final enrolment	01/05/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Macmillan Reader in Palliative Medicine and Medical Oncology

Nottingham
NG5 1PB
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2RD
England
United Kingdom

Phone	+44 (0)115 951 5151
Email	paul.cartledge@nottingham.ac.uk
Website	http://www.nottingham.ac.uk/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Charity

Cancer Research UK (UK) (Ref: C18598/A8211)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2010		Yes	No