Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
24/05/2012
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 AER Drummond

ORCID ID

Contact details

Ageing and Disability Research Unit
B Floor
Medical School
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 0115 924 9924 (44050)
Avril.Drummond@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192119065

Study information

Scientific title

Acronym

Study hypothesis

To identify whether occupational therapy intervention improves the mood, fatigue management and activities of daily living (ADL) performance of outpatient oncology patients.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

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

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

We aim to follow up two groups of patients at 6 and 12 weeks after randomisation and compare outcome.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

17/09/2002

Overall trial end date

09/05/2003

Reason abandoned

Eligibility

Participant inclusion criteria

All patients will be seen on their second or third clinic appointment.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Total number of subjects = 52

Participant exclusion criteria

Living outside the hospital catchment area or refusal to consent.

Recruitment start date

17/09/2002

Recruitment end date

09/05/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ageing and Disability Research Unit
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2006 results on http://www.ingentaconnect.com/content/cot/bjot/2006/00000069/00000003/art00006 = Harrison-Paul, Jane; Drummond, Avril E.R., The British Journal of Occupational Therapy, Volume 69, Number 3, March 2006 , pp. 130-133(4).

Publication citations

Additional files

Editorial Notes