Breast NeoplasmsNCT02581709
An Intervention Programme to Reduce Cognitive Impairment Due to Cancer
A study testing Countering cognitive impairment in people with Breast Neoplasms and Colorectal Neoplasms, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Colorectal Neoplasms
- What is being tested?
- Countering cognitive impairment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cancer Centre, City Hospital, Belfast HSC Trust
Belfast, Antrim, BT12
About this study
Official title: The Development and Feasibility Testing of an Intervention Programme to Reduce Cognitive Impairment Due to Cancer Treatment
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.
Read the 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.
- Conditions
- Breast Neoplasms, Colorectal Neoplasms
- Being tested
- Countering cognitive impairment
- Keywords
- Feasibility study, Cognition, Chemotherapy, Neoplasms
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Countering cognitive impairmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Countering cognitive impairment | Experimental | 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. Receives: Behavioral: Countering cognitive impairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 27 weeks
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before Chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startMay 2016
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: Very low recruitment and funding was unavailable to support further research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Cancer Research Network
- Responsible party
- Principal investigator, Michael Donnelly, Queen's University, Belfast
- Investigators
- Michael Donnelly, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581709
- Sponsor's protocol ID
- STL/5086/14
- Status last verified
- Dec 2021
- First submitted
- 15 Oct 2015
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Feasibility Testing of an Intervention Programme to Reduce Cognitive Impairment Due to Cancer Treatment
- ClinicalTrials.gov ID
- NCT02581709
- Acronym / sponsor ID
- STL/5086/14
- Conditions
- Breast Neoplasms, Colorectal Neoplasms
- Keywords
- Feasibility study, Cognition, Chemotherapy, Neoplasms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very low recruitment and funding was unavailable to support further research.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Cancer Research Network
- Study start
- May 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Countering cognitive impairment | Experimental | Behavioral: Countering cognitive impairmentEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Countering cognitive impairmentThe 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. | Behavioural | Countering cognitive impairment |
Primary outcome
Feasibility of intervention implementation
Time frame: After 27 weeks
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.
12 secondary outcomes
Hopkins Verbal Learning Test
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
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
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
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
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)
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)
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)
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)
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)
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)
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
Time frame: Before Chemotherapy
Results and safety
The study was stopped early (reason given: Very low recruitment and funding was unavailable to support further research.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Donnelly, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Countering cognitive impairment in people with Breast Neoplasms and Colorectal Neoplasms, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Very low recruitment and funding was unavailable to support further research.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention implementation (time frame: After 27 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.