The goal of this research study is to test the feasibility of an intervention programme to reduce cognitive impairment due to cancer treatment. The investigators want to find out how acceptable the intervention and procedures are for cancer patients.
The intervention programme will consist of the following components: education about cancer-related cognitive impairment, relaxation techniques, compensatory techniques, goal-setting and lifestyle advice. Each session will last between 90 and 120 minutes, once a week for six weeks. The intervention will be delivered in a group setting, in a non-clinical environment by the investigators. The investigators aim to recruit 54 cancer patients from the local Cancer Centre onto the study. The cognitive functioning of cancer patients due to start chemotherapy will be assessed. Each patient's cognitive function will be reassessed after completion of chemotherapy and additional self-report measures will be administered. Patients who demonstrate cognitive decline over the course of chemotherapy will be invited to take part in the intervention programme. All other patients will be given an information sheet and advised to contact a member of their health-care team if they notice any changes in their cognitive function. The investigators aim to take 30 patients through the intervention. At the end of the intervention, each participant will complete an intervention evaluation questionnaire in addition to the cognitive functioning assessments and self-report measures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
The intervention will include education about cancer-related cognitive impairment, instruction on relaxation techniques, compensatory techniques, goal-setting and lifestyle advice. Each session will last between 90 and 120 minutes, once a week for six weeks. The intervention will be delivered in a group setting, in a non-clinical environment by the investigators.
Cancer Centre, City Hospital, Belfast HSC Trust
Belfast, Antrim, United Kingdom
Feasibility of intervention implementation
The investigators aim to assess the acceptability of the intervention programme and its procedures to patients enrolled in the study. This is a non-validated questionnaire designed specifically for this study. Participants are required to rate the verbal and written information about the study, advice about the study, overall intervention, specific intervention components, each assessment visit and procedure, length of time of intervention and assessment visits on a three- or five-point likert scale. Open-ended questions asking participants to provide further information were provided.
Time frame: After 27 weeks
Hopkins Verbal Learning Test
This test is used to capture memory and learning. As this is a feasibility study this measure is not used to assess the effectiveness of the intervention and only means and standard deviations will be calculated.
Time frame: At baseline, after chemotherapy (15 weeks since baseline assessment for breast cancer patients and 21 weeks since baseline for colorectal cancer patients) and after the intervention (approximately 27 weeks from baseline assessment).
Reitan's Trail Making Test (TMT) A and B
This test is used to capture executive functions and visuomotor speed. As this is a feasibility study this measure is not used to assess the effectiveness of the intervention and only means and standard deviations will be calculated.
Time frame: At baseline, after chemotherapy (15 weeks since baseline assessment for breast cancer patients and 21 weeks since baseline for colorectal cancer patients) and after the intervention (approximately 27 weeks from baseline assessment).
Controlled oral Word Association (COWA) sub-test of the Multilingual Aphasia Examination
This test is used to capture executive functions and verbal ability. As this is a feasibility study this measure is not used to assess the effectiveness of the intervention and only means and standard deviations will be calculated.
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Time frame: At baseline, after chemotherapy (15 weeks since baseline assessment for breast cancer patients and 21 weeks since baseline for colorectal cancer patients) and after the intervention (approximately 27 weeks from baseline assessment).
Neuropsychological Assessment Battery Digit Span sub-test
This test is used to capture working memory and attention. As this is a feasibility study this measure is not used to assess the effectiveness of the intervention and only means and standard deviations will be calculated.
Time frame: At baseline, after chemotherapy (15 weeks since baseline assessment for breast cancer patients and 21 weeks since baseline for colorectal cancer patients) and after the intervention (approximately 27 weeks from baseline assessment).
STROOP test
This test is used to capture attention. As this is a feasibility study this measure is not used to assess the effectiveness of the intervention and only means and standard deviations will be calculated.
Time frame: At baseline, after chemotherapy (15 weeks since baseline assessment for breast cancer patients and 21 weeks since baseline for colorectal cancer patients) and after the intervention (approximately 27 weeks from baseline assessment).
Functional Assessment of Cancer Therapy- Cognitive Subscale (FACT-Cog)
This test is used to self-reported cognitive function. As this is a feasibility study this measure is not used to assess the effectiveness of the intervention and only means and standard deviations will be calculated.
Time frame: After chemotherapy (15 weeks since baseline assessment for breast cancer patients and 21 weeks since baseline for colorectal cancer patients) and after the intervention (approximately 27 weeks from baseline assessment).
Short form health survey (SF-36)
This test is used to self-reported health-related quality of life. As this is a feasibility study this measure is not used to assess the effectiveness of the intervention and only means and standard deviations will be calculated.
Time frame: After chemotherapy (15 weeks since baseline assessment for breast cancer patients and 21 weeks since baseline for colorectal cancer patients) and after the intervention (approximately 27 weeks from baseline assessment).
Centre for Epidemiological studies Depression- Revised scale (CESD-R)
This test is used to self-reported depression. As this is a feasibility study this measure is not used to assess the effectiveness of the intervention and only means and standard deviations will be calculated.
Time frame: After chemotherapy (15 weeks since baseline assessment for breast cancer patients and 21 weeks since baseline for colorectal cancer patients) and after the intervention (approximately 27 weeks from baseline assessment).
Hospital Anxiety and Depression Scale- Anxiety sub-scale (HADS-A)
This test is used to measure state anxiety. As this is a feasibility study this measure is not used to assess the effectiveness of the intervention and only means and standard deviations will be calculated.
Time frame: After chemotherapy (15 weeks since baseline assessment for breast cancer patients and 21 weeks since baseline for colorectal cancer patients) and after the intervention (approximately 27 weeks from baseline assessment).
Functional Assessment of Chronic Illness Therapy- Fatigue sub-scale (FACIT-F)
This test is used to measure self-reported fatigue. As this is a feasibility study this measure is not used to assess the effectiveness of the intervention and only means and standard deviations will be calculated.
Time frame: After chemotherapy (15 weeks since baseline assessment for breast cancer patients and 21 weeks since baseline for colorectal cancer patients) and after the intervention (approximately 27 weeks from baseline assessment).
Pittsburgh Sleep Quality Index (PSQI)
This test is used to measure self-reported sleep disturbances. As this is a feasibility study this measure is not used to assess the effectiveness of the intervention and only means and standard deviations will be calculated.
Time frame: After chemotherapy (15 weeks since baseline assessment for breast cancer patients and 21 weeks since baseline for colorectal cancer patients) and after the intervention (approximately 27 weeks from baseline assessment).
Cognitive Reserve Scale
This scale is used to capture engagement in cognitive activities throughout the lifespan.
Time frame: Before Chemotherapy