Back to resultsAn Intervention Programme to Reduce Cognitive Impairment Due to Cancer
Primary Purpose
Breast Neoplasms, Colorectal Neoplasms
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Countering cognitive impairment
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Neoplasms focused on measuring Feasibility study, Cognition, Chemotherapy, Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Aged >18 years
- 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:
- Treatment plan does not include chemotherapy.
- 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.
Sites / Locations
- Cancer Centre, City Hospital, Belfast HSC Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Countering cognitive impairment
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Cognitive Reserve Scale
This scale is used to capture engagement in cognitive activities throughout the lifespan.
Full Information
NCT ID
NCT02581709
First Posted
October 15, 2015
Last Updated
December 6, 2021
Sponsor
Queen's University, Belfast
Collaborators
Belfast Health and Social Care Trust, Cancer Research Network
1. Study Identification
Unique Protocol Identification Number
NCT02581709
Brief Title
An Intervention Programme to Reduce Cognitive Impairment Due to Cancer
Official Title
The Development and Feasibility Testing of an Intervention Programme to Reduce Cognitive Impairment Due to Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Very low recruitment and funding was unavailable to support further research.
Study Start Date
May 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
Belfast Health and Social Care Trust, Cancer Research Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Colorectal Neoplasms
Keywords
Feasibility study, Cognition, Chemotherapy, Neoplasms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Countering cognitive impairment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Countering cognitive impairment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of intervention implementation
Description
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
Secondary Outcome Measure Information:
Title
Hopkins Verbal Learning Test
Description
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).
Title
Reitan's Trail Making Test (TMT) A and B
Description
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).
Title
Controlled oral Word Association (COWA) sub-test of the Multilingual Aphasia Examination
Description
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.
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).
Title
Neuropsychological Assessment Battery Digit Span sub-test
Description
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).
Title
STROOP test
Description
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).
Title
Functional Assessment of Cancer Therapy- Cognitive Subscale (FACT-Cog)
Description
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).
Title
Short form health survey (SF-36)
Description
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).
Title
Centre for Epidemiological studies Depression- Revised scale (CESD-R)
Description
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).
Title
Hospital Anxiety and Depression Scale- Anxiety sub-scale (HADS-A)
Description
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).
Title
Functional Assessment of Chronic Illness Therapy- Fatigue sub-scale (FACIT-F)
Description
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).
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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).
Title
Cognitive Reserve Scale
Description
This scale is used to capture engagement in cognitive activities throughout the lifespan.
Time Frame
Before Chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged >18 years
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:
Treatment plan does not include chemotherapy.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Donnelly, PhD
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Centre, City Hospital, Belfast HSC Trust
City
Belfast
State/Province
Antrim
ZIP/Postal Code
BT12
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
An Intervention Programme to Reduce Cognitive Impairment Due to Cancer
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