Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
The TLC study
Study hypothesis
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
Dyfed Powys Research Ethics Committee, Carmarthen, Wales SA31 3YH (ref: 05/WMWO1/45)
Study design
Multicentre single-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/07/2007
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
300
Participant 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
Recruitment start date
01/07/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Medicine
Swansea
SA2 8PP
United Kingdom
Sponsor information
Organisation
Breast Test Wales
Sponsor details
18 Cathedral Road
Cardiff
CF11 9LJ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Breast Test Wales
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