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

Not Applicable

Completed

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

• Registration Number: ISRCTN89206644
• Lead Sponsor: Breast Test Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-11
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 300

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score on the negative sub scale of the Psychological Consequences Questionnaire<br><br>All primary and secondary outcomes will be assessed at baseline, 6 weeks, 6 months and 1 year.

Secondary Outcome Measures

Name	Time	Method
1. SF-36® Health Survey <br>2. Hospital Anxiety and Depression Scale <br>3. Euroquol EQ-5D <br>4. Short Explanatory Model Interview for patient experiences<br><br>All primary and secondary outcomes will be assessed at baseline, 6 weeks, 6 months and 1 year.