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
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

School of Medicine
Swansea University
Swansea
SA2 8PP
United Kingdom

Study information

Study designMulticentre single-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised controlled trial to investigate the effect of psychological support for women called back for assessment following breast cancer screening: The TLC study
Study acronymThe TLC study
Study objectivesCompared 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) studiedDepression and anxiety in women recalled for assessment following an abnormality on breast screening
InterventionSome 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 typeOther
Primary outcome measureScore 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 measures1. 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 date01/07/2007
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants300
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2007
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

School of Medicine
Swansea
SA2 8PP
United Kingdom

Sponsor information

Breast Test Wales
Government

18 Cathedral Road
Cardiff
CF11 9LJ
United Kingdom

Website http://www.screeningservices.org.uk/btw/index_eng.asp
ROR logo "ROR" https://ror.org/00265c946

Funders

Funder type

Government

Breast Test Wales

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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