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

ISRCTN	ISRCTN60459823
DOI	https://doi.org/10.1186/ISRCTN60459823
Protocol serial number	N0063116010
Sponsor	Department of Health (UK)
Funder	Christie Hospital NHS Trust (UK)

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 14/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr G Jayson
Scientific

Medical Oncology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom

Phone	+44 (0)161 446 3750
Email	gordon.jayson@christie-tr.nwest.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/10/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key 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.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	26/04/2002
Date of final enrolment	31/10/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Christie Hospital NHS Trust

Manchester
M20 4BX
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/02/2018: No publications found in PubMed, verifying study status with principal investigator.