Condition category
Mental and Behavioural Disorders
Date applied
22/10/2009
Date assigned
11/11/2009
Last edited
21/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Keith Lloyd

ORCID ID

Contact details

School of Medicine
Swansea University
Swansea
SA2 8PP
United Kingdom

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

http://www.screeningservices.org.uk/btw/index_eng.asp

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

Publication citations

Additional files

Editorial Notes

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