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
Protocol serial number	Version 1.1
Sponsor	University of Nottingham (UK)
Funder	Cancer Research UK (UK) (Ref: C18598/A8211)

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

Primary study design	Interventional
Study design	Non-randomised, unblinded single-group design
Secondary study design	Non randomised controlled trial
Study type	Participant 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(s)	Percentage acceptability of assessing physical activity level with an ActivPAL monitor over one week in patients with lung or upper gastro-intestinal cancer.
Key secondary outcome measure(s)	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.
Completion date	01/05/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex
Target sample size at registration	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

United Kingdom
England

Study participating centre

Macmillan Reader in Palliative Medicine and Medical Oncology

Nottingham
NG5 1PB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes