Efficacy of neurocognitive training as an intervention for helping breast cancer survivors improve and sustain their work ability
- Conditions
- Breast cancerCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN11333136
- Lead Sponsor
- Birkbeck College, University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 80
Current inclusion criteria as of 06/02/2019:
1. 'Must be between 6 months to 60 months since the end of their active cancer treatment (i.e. no longer receiving chemotherapy and/or radiotherapy)
2. Receiving hormone replacement therapies or target therapies (i.e. Herceptin injections)
3. Clinical diagnosis of primary breast cancer
4. Aged between 18 years old and 65 years old
5. Attending paid work at the time of recruitment (note, there is no limit to the number of hours but the work must be considered regular)
6. Experiencing a decline in their work ability as a direct result of cognitive difficulties
Previous inclusion criteria as of 05/02/2019:
1. 'Must be between 12 months to 60 months since the end of their active cancer treatment (i.e. no longer receiving chemotherapy and/or radiotherapy)
2. Receiving hormone replacement therapies or target therapies (i.e. Herceptin injections)
3. Clinical diagnosis of primary breast cancer
4. Aged between 18 years old and 65 years old
5. Attending paid work at the time of recruitment (note, there is no limit to the number of hours but the work must be considered regular)
6. Experiencing a decline in their work ability as a direct result of cognitive difficulties
Previous inclusion criteria:
Breast cancer survivors:
1. Must be between 12 months to 36 months since the end of their active cancer treatment (i.e. no longer receiving chemotherapy and/or radiotherapy)
2. Receiving hormone replacement therapies or target therapies (i.e. Herceptin injections)
3. Clinical diagnosis of primary breast cancer
4. Aged between 18 years old and 50 years old
5. Attending paid work at the time of recruitment (note, there is no limit to the number of hours but the work must be considered regular)
6. Experiencing a decline in their work ability as a direct result of cognitive difficulties
Current exclusion criteria as of 20/05/2019:
Breast Cancer survivors:
1. Receiving active cancer treatments including, chemotherapy and/or radiotherapy
2. Under 6-months since the completion of active treatment for both chemotherapy and/or radiotherapy
3. Clinical diagnosis of secondary or metastatic breast cancer
4. Over the age of 65 years old at the time of recruitment
5. Not attending paid work at the time of recruitment
6. Not experiencing any changes or difficulties in their work ability associated with cognitive impairment(s)
7. Unable to read or understand English
Previous exclusion criteria:
Breast cancer survivors:
1. Receiving active cancer treatments including, chemotherapy and/or radiotherapy
2. Under 12 months since the completion of active treatment for both chemotherapy and/or radiotherapy
3. Clinical diagnosis of secondary or metastatic breast cancer
4. Over the age of 50 years old at the time of recruitment
5. Not attending paid work at the time of recruitment
6. Not experiencing any changes or difficulties in their work ability associated with cognitive impairment(s)
7. Unable to read or understand English
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Objective and subjective cognitive function, assessed at four timepoints using:<br> 1. Computerised working memory tasks (OSPAN and CDT) at baseline (pre-training), immediately post-training, 6-month follow-up and 1-year follow-up<br> 2. Cognitive questionnaires at baseline (pre-training), immediately post-training, 6-month follow-up and 1-year follow-up:<br> 2.1. Functional Assessment of Cancer Therapy-Cognitive Scale (FACT-Cog, version 3)<br> 2.2. Rumination Response Scale (RRS)<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Perceived emotional well-being and quality of life, assessed at four timepoints (baseline [pre-training], immediately post-training, 6-months follow-up and 1-year follow-up):<br> 1.1. Quality of life measured by the European Organization for Research and Treatment Quality of Life (EORTC-QLQ-C30)<br> 1.2. Anxiety symptomology measured by Hospital Anxiety and Depression Scale (HADS)<br> 1.3. Depression symptomology measured by the center for Epidemiologic Studies Depression Scale (CES-D)<br> 2. Perceived work ability assessed using the Work Limitations Questionnaire (WLQ) at four timepoints (baseline [pre-training], immediately post-training, 6-month follow-up and 1-year follow-up)<br> 3. Event-related potential (ERP) markers of attentional control measured by EEG at four timepoints: baseline (pre-training), immediately post-training, 6-month follow-up and 1-year follow-up<br>