Condition category
Cancer
Date applied
05/09/2007
Date assigned
05/12/2007
Last edited
17/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Wilcock

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1.1

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the Oxfordshire Research Ethics Committee ‘A’ Study on the 8th March 2007 (ref: 07/Q1604/16).

Study design

Non-randomised, unblinded single-group design

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/08/2007

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

1. Currently receiving chemo-radiation therapy
2. Less than four weeks post surgery

Recruitment start date

01/08/2007

Recruitment end date

01/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Macmillan Reader in Palliative Medicine and Medical Oncology
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2RD
United Kingdom
+44 (0)115 951 5151
paul.cartledge@nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK) (Ref: C18598/A8211)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19956982

Publication citations

  1. Results

    Maddocks M, Byrne A, Johnson CD, Wilson RH, Fearon KC, Wilcock A, Physical activity level as an outcome measure for use in cancer cachexia trials: a feasibility study., Support Care Cancer, 2010, 18, 12, 1539-1544, doi: 10.1007/s00520-009-0776-2.

Additional files

Editorial Notes