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 |
| Secondary identifying numbers | N0063116010 |
- 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
Scientific
Medical Oncology
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
| Phone | +44 (0)161 446 3750 |
|---|---|
| gordon.jayson@christie-tr.nwest.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 26/04/2002 |
| Completion date | 31/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
Christie Hospital NHS Trust
Manchester
M20 4BX
United Kingdom
M20 4BX
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Christie Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
14/02/2018: No publications found in PubMed, verifying study status with principal investigator.
