A clinical trial to investigate the effect of psychological support for women called back for assessment following breast cancer screening: The TLC study
ISRCTN | ISRCTN89206644 |
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DOI | https://doi.org/10.1186/ISRCTN89206644 |
Secondary identifying numbers | N/A |
- Submission date
- 22/10/2009
- Registration date
- 11/11/2009
- Last edited
- 21/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Prof Keith Lloyd
Scientific
Scientific
School of Medicine
Swansea University
Swansea
SA2 8PP
United Kingdom
Study information
Study design | Multicentre single-blind randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Screening |
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 to investigate the effect of psychological support for women called back for assessment following breast cancer screening: The TLC study |
Study acronym | The TLC study |
Study objectives | Compared with care as usual, a self-help psychological support package (TLC) for women recalled for assessment following an abnormality on breast screening will result in significantly reduced scores on the Psychological Consequences Questionnaire (PCQ) at six week follow up. |
Ethics approval(s) | Dyfed Powys Research Ethics Committee, Carmarthen, Wales SA31 3YH (ref: 05/WMWO1/45) |
Health condition(s) or problem(s) studied | Depression and anxiety in women recalled for assessment following an abnormality on breast screening |
Intervention | Some women invited for breast screening are then asked to attend for further tests. This study looks at a relaxation and self help package known as "Travel Lightly Companion" (TLC) to see if it reduces any distress linked to recall. The TLC pack consists of guided self help presented as a Compact Disc of relaxation music with relaxation exercises including breathing and guided imagery exercises. Women agreeing to take part will get either the TLC package or care as usual. Participants fill out some questionnaires at the start, 6 weeks, 6 months and 1 year later. |
Intervention type | Other |
Primary outcome measure | Score on the negative sub scale of the Psychological Consequences Questionnaire All primary and secondary outcomes will be assessed at baseline, 6 weeks, 6 months and 1 year. |
Secondary outcome measures | 1. SF-36® Health Survey 2. Hospital Anxiety and Depression Scale 3. Euroquol EQ-5D 4. Short Explanatory Model Interview for patient experiences All primary and secondary outcomes will be assessed at baseline, 6 weeks, 6 months and 1 year. |
Overall study start date | 01/07/2007 |
Completion date | 31/12/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 300 |
Key inclusion criteria | 1. Females, age 50-64 2. Those attending a Breast Test Wales Centre for a recall visit following initial breast screening 3. Participant should be willing to give verbal and written consent for the study 4. Participant should be willing to complete a questionnaire prior to assessment at baseline, within 1 month, 6 months and 12 months post assessment |
Key exclusion criteria | 1. Those who are recalled for technical reasons (technical recall) 2. Women who have had a previous recall within the last three years 3. Women who have any hearing, visual or learning impairment which would not allow them to complete the questionnaires or listen to the support package 4. Women who themselves have identified breast problems (clinical override) 5. Women who cannot answer questionnaires in English or Welsh |
Date of first enrolment | 01/07/2007 |
Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
School of Medicine
Swansea
SA2 8PP
United Kingdom
SA2 8PP
United Kingdom
Sponsor information
Breast Test Wales
Government
Government
18 Cathedral Road
Cardiff
CF11 9LJ
United Kingdom
Website | http://www.screeningservices.org.uk/btw/index_eng.asp |
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https://ror.org/00265c946 |
Funders
Funder type
Government
Breast Test Wales
No information available
Results and Publications
Intention to publish date | |
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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
21/06/2016: No publications found, verifying study status with principal investigator