An Intervention Programme to Reduce Cognitive Impairment Due to Cancer
NCT ID: NCT02581709
Last Updated: 2021-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
15 participants
INTERVENTIONAL
2016-05-31
2017-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Countering cognitive impairment
Each participant will complete neuropsychological assessments at baseline (prior to chemotherapy) and after chemotherapy. Patients identified as experiencing cognitive decline measured using Reliable Change Index on at least one cognitive function measure from before until after chemotherapy will be offered the intervention. Participants in the interventions will complete a neuropsychological assessment after completion of the intervention. Questionnaires to assess other non-cognitive factors e.g. quality-of-life will be administered at the end of chemotherapy to all participants and after the intervention to participants in the intervention.
Countering cognitive impairment
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.
Interventions
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Countering cognitive impairment
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.
Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of early stage breast or colorectal cancer (Stage I-III disease)
* Are planned to receive standard care adjuvant chemotherapy.
* Able to complete Neuropsychological test assessment pre- and post- chemotherapy receipt.
* Proficiency in the English language
* Able to provide informed consent
* Patients with breast cancer can be receiving standard care hormonal therapy or radiotherapy
Exclusion Criteria
* Diagnosed with metastatic cancer
* Treatment plan includes cranial radiation, brain surgery or intrathecal therapy.
* History of previous cancer, as previous treatment or experience may contribute to cognitive impairments (with the exception of non-melanoma skin cancer).
* History of cranial radiation, brain surgery or intrathecal therapy due to the direct impact on the brain.
* History of, or, comorbid condition which may alter cognitive function tests i.e. stroke, head injury, epilepsy, Parkinson's disease, Huntington's disease, Alzheimer's disease, encephalitis, substance abuse, bipolar disorder, psychosis, schizophrenia and learning disability.
* Current use of psycho-stimulant medication e.g. Methylphenidate which increases activity in the central nervous system, or central nervous system (CNS) depressant medication e.g. Benzodiazepines and Barbiturates due to slowing down of cognitive processes. Use of commonly prescribed anti-depressants e.g. Monoamine Oxidase Inhibitors (MAOIs), Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin Noradrenaline Reuptake Inhibitors (SNRIs) or Tricyclic Antidepressants (TCAs) is permitted.
* Have a Mini-Mental Status Examination score ≤23 indicative of substantial cognitive impairment including dementia.
* Current uncontrolled mood disorder e.g. Major depression.
18 Years
ALL
No
Sponsors
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Belfast Health and Social Care Trust
OTHER
Cancer Research Network
OTHER
Queen's University, Belfast
OTHER
Responsible Party
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Michael Donnelly
Professor Michael Donnelly
Principal Investigators
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Michael Donnelly, PhD
Role: PRINCIPAL_INVESTIGATOR
Queen's University, Belfast
Locations
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Cancer Centre, City Hospital, Belfast HSC Trust
Belfast, Antrim, United Kingdom
Countries
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Other Identifiers
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STL/5086/14
Identifier Type: -
Identifier Source: org_study_id