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
DOI	https://doi.org/10.1186/ISRCTN89206644
Protocol serial number	N/A
Sponsor	Breast Test Wales
Funder	Breast Test Wales

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

School of Medicine
Swansea University
Swansea
SA2 8PP
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre single-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

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

21/06/2016: No publications found, verifying study status with principal investigator