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

ISRCTN	ISRCTN71264775
DOI	https://doi.org/10.1186/ISRCTN71264775
Protocol serial number	N0192119065
Sponsor	Department of Health (UK)
Funder	Queen's Medical Centre University Hospital NHS Trust - UK (NHS R&D Support Funding)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	To 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) studied	Cancer: All
Intervention	Intervention 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 type	Other
Primary outcome measure(s)	We aim to follow up two groups of patients at 6 and 12 weeks after randomisation and compare outcome.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	09/05/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	52
Key inclusion criteria	All patients will be seen on their second or third clinic appointment.
Key exclusion criteria	Living outside the hospital catchment area or refusal to consent.
Date of first enrolment	17/09/2002
Date of final enrolment	09/05/2003

Ageing and Disability Research Unit

Nottingham
NG7 2UH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2006		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes