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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2009
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. CONDITION: Depression and anxiety in women recalled for assessment following an abnormality on breast screening ; Mental and Behavioural Disorders ; Depressive episode PRIMARY OUTCOME: 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: 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. 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
Epistemonikos ID: 31f1956a2da217805e485f0c18412a0be8abbb4d
First added on: Aug 22, 2024