Cognitive Changes With Adjuvant Therapy For Breast Cancer: A Longitudinal Study

Not Applicable

Completed

• Conditions: breast cancer; Cancer - Breast

• Registration Number: ACTRN12609000893202
• Lead Sponsor: Dr Michael Jameson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1.Women diagnosed with early breast cancer treated by surgery with curative intent
2. Adjuvant therapy is planned (chemotherapy, hormone therapy, radiotherapy, or any combination of the above)
3. Fluency in English

Exclusion Criteria

1. Current use of hormone replacement therapy or hormonal contraception
2. Severe current mental illness
3. Not able to comply with the test requirements
4. Pre-existing significant neurological impairment

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of deficits in cognitive function associated with adjuvant therapies for breast cancer over a 2 year period using questionnaires and tests of memory, concentration, processing skills and task completion.[Assessed at 3 months, 6 months 12 months and 24 months from study entry (in comparison to baseline evaluation)]

Secondary Outcome Measures

Name	Time	Method
The time course of deficits in cognitive function associated with adjuvant therapies for breast cancer over a 2 year period.[Assessed at 3 months, 6 months 12 months and 24 months from study entry (in comparison to baseline evaluation)];Changes in quality of life during adjuvant therapies for breast cancer using the European Organisation for Research and Treatment of Cancer (EORTC) QLQC30 quality of life questionnaire[Assessed at 3 months, 6 months 12 months and 24 months from study entry (in comparison to baseline evaluation)];Changes in mood during adjuvant therapies for breast cancer assessed using questionnaires[Assessed at 3 months, 6 months 12 months and 24 months from study entry (in comparison to baseline evaluation)];The role played by menopausal status in cognitive functioning during adjuvant therapies for breast cancer (with menopausal status established by direct questioning of patients)[Assessed at 3 months, 6 months 12 months and 24 months from study entry (in comparison to baseline evaluation)]