Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
14/12/2015
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 G Jayson

ORCID ID

Contact details

Medical Oncology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
+44 (0)161 446 3750
gordon.jayson@christie-tr.nwest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0063116010

Study information

Scientific title

A randomised controlled trial assessing effectiveness of six sessions of brief cognitive behaviour therapy in reducing psychological distress in women who have completed a course of intravenous chemotherapy for ovarian cancer

Acronym

Study hypothesis

The aim of this project is to carry out a randomised controlled trial, to assess the hypothesis and gain information regarding the acceptability of such a programme.

Please note that as of 11/08/2009 this record was extensively updated

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

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

Ovarian cancer

Intervention

Current information as of 11/08/2009:
At the end of chemotherapy those who have consented to the study will be asked to complete a Hospital Anxiety and Depression Scale (HADS) to assess their suitability for randomisation. Those scoring 7 will then be randomised into
1. Intervention arm - up to 6 30 minute sessions of cognitive behaviour therapy
2. No intervention

Initial information at time of registration:
Randomised controlled trial:
Arm A: no intervention
Arm B: intervention

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Added 11/08/2009:
Women in both arms of the study will be assessed using:
1. HADS and Worry About Cancer Scale
2. A Social Support Inventory (SSI)
3. an Impact of Events Scale
4. A scale assessing the beliefs about controllability and social worry
These will be administered at the end of chemotherapy and 3 months following completion of chemotherapy. These questionnaires will be administered by a member of the research team who will not be involved in the cognitive behaviour therapy sessions.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

26/04/2002

Overall trial end date

31/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Current information as of 11/08/2009:
1. Patients newly diagnosed with ovarian cancer, attending the outpatient clinic of Dr G Jayson
2. Age <55 years
3. Written informed consent
4. Hospital Anxiety and Depression Scale (HADS) score of 7

Initial information at time of registration:
Patients with ovarian cancer, who are less than 55 years of age, will be giving an information sheet outlining the study.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

26/04/2002

Recruitment end date

31/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Christie Hospital NHS Trust
Manchester
M20 4BX
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

Hospital/treatment centre

Funder name

Christie Hospital NHS Trust (UK)

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

Publication citations

Additional files

Editorial Notes