A randomised controlled trial of occupational therapy in oncology: a pilot study

ISRCTN ISRCTN71264775
DOI https://doi.org/10.1186/ISRCTN71264775
Secondary identifying numbers N0192119065
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
24/05/2012
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 AER Drummond
Scientific

Ageing and Disability Research Unit
B Floor
Medical School
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom

Phone +44 0115 924 9924 (44050)
Email Avril.Drummond@nottingham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesTo identify whether occupational therapy intervention improves the mood, fatigue management and activities of daily living (ADL) performance of outpatient oncology patients.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer: All
InterventionIntervention arms: Patients will receive a minimum of five sessions.
Session 1 - initial interview, general assessment and baseline assessments.
Session 2 - fatigue management/energy conservation session and equipment provision.
Session 3 - anxiety management/relaxation session.
Session 4 -fatigue/anxiety management session - check understanding and use of principals.
Session 5 - review progress.
Further sessions will be conducted if considered appropriate, up to a maximum of seven.
Intervention typeOther
Primary outcome measureWe aim to follow up two groups of patients at 6 and 12 weeks after randomisation and compare outcome.
Secondary outcome measuresNot provided at time of registration
Overall study start date17/09/2002
Completion date09/05/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsTotal number of subjects = 52
Key inclusion criteriaAll patients will be seen on their second or third clinic appointment.
Key exclusion criteriaLiving outside the hospital catchment area or refusal to consent.
Date of first enrolment17/09/2002
Date of final enrolment09/05/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Ageing and Disability Research Unit
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Queen's Medical Centre University Hospital NHS Trust - UK (NHS R&D Support Funding)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2006 Yes No