None listed
Conditions
Brief summary
This study is evaluating a home and internet based “brain training programme” (cognitive rehabilitation programme) in cancer survivors who have noticed changes in their memory, concentration and thinking (cognition) following chemotherapy. This trial will recruit cancer survivors aged 18 and above who have completed a minimum of 3 cycles of chemotherapy in the last 6 – 60 months for an early cancer. There should be no evidence of cancer recurrence. Potential participants must report changes in their memory and / or concentration. All study participants will take part in a telephone session where they will be given skills to help manage their cognitive difficulties. In addition, half of the participants will receive the computer programme which is to be used for 4 x forty minute sessions per week for 15 weeks (i.e. 40 hours). Participants will be asked to complete questionnaires about their memory, mood, energy levels, quality of life and stress. They will also be asked to perform a 20 minute computer cognition exercise. The questionnaires and cognition exercise will take approximately 45 minutes to complete in total and these tests will be completed on 3 occasions during the trial (i.e. at baseline, on completion of the brain training programme and 6 months following completion of the brain training programme). The computer programme, questionnaires and cognition exercise can all be completed at home and participants will therefore require access to computer and internet facilities. This study will measure the effectiveness of the computer programme in improving self reported cognitive function and performance, mood, energy, quality of life and stress.
Interventions
A home based, computerised cognitive rehabilitation programme to be used for 4x forty-minute sessions per week for a total of 15 weeks (i.e. 40 hours).
There are five training exercises that form the core of the program, each targeting a different area of brain functioning. These cognitive targets include visual precision, divided attention, working memory, useful field of view and visual processing speed. Each exercise has an accompanying assessment that sets an improvement goal and measures pr
A home based, computerised cognitive rehabilitation programme to be used for 4x forty-minute sessions per week for a total of 15 weeks (i.e. 40 hours). There are five training exercises that form the core of the program, each targeting a different area of brain functioning. These cognitive targets include visual precision, divided attention, working memory, useful field of view and visual processing speed. Each exercise has an accompanying assessment that sets an improvement goal and measures progress against that goal. The exercises adapt to an individual’s performance and all patients will complete a recommended schedule of training as per the programme design.
Sponsors
Dr Janette Vardy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of a primary malignancy for which definitive treatment was performed. 2. Completed a minimum of 3 cycles of potentially curative chemotherapy within the last 6-60 months. 3. Aged 18 years and above. 4. Self reported changes in memory and concentration as per the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire –C30 Cognitive Functioning scale (EORTC-CF) 5. Speak fluent English and read to a year 8 standard. 6. Give written informed consent. 7. Radiotherapy and/or immunotherapy (e.g. trastuzumab, lapatinib, bevacizumab or cetuximab) (if received) must have been completed at least 12 weeks prior to randomisation. 8. Hormonal treatment (including tamoxifen or an aromatase inhibitor) is permitted providing treatment has been commenced at least 4 weeks prior to randomisation. Change of hormonal therapy should not be anticipated within the next 6 months, nor should it be likely to be ceased within 6 months. 9. Easy access to computer and internet facilities. 10. Participants are expected to be able to complete the study and be available for follow up.
Exclusion criteria
1. Eastern Cooperative Oncology Group (ECOG) Performance Status of > 2. 2. Any evidence of locally recurrent or metastatic disease. 3. Any active psychiatric diagnosis or history of a cognitive disorder. Psychotropic medications are permitted if the patient is established on a stable regime and dosing schedule. 4. Pre-existing neurological condition or any other co-morbidity, which would interfere with their ability to perform cognitive testing. 5. Prior malignancy within the last 5 years (other than non-melanomatous skin cancer, cervical cancer in-situ and the cancer of interest for which they received their chemotherapy). 6. Any previous chemotherapy other than that given for the cancer of interest.
Outcome results
None listed