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A clinical trial to investigate the effect of psychological support for women called back for assessment following breast cancer screening: The TLC study

A randomised controlled trial to investigate the effect of psychological support for women called back for assessment following breast cancer screening: The TLC study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN89206644
Enrollment
300
Registered
2009-11-11
Start date
2007-07-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression and anxiety in women recalled for assessment following an abnormality on breast screening Mental and Behavioural Disorders Depressive episode

Interventions

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 reduce

Sponsors

Breast Test Wales
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026