Clinical trial NCT02581709: 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
Overall status: TERMINATED
Phase: NA
Conditions: Breast Neoplasms
Colorectal Neoplasms
Keywords: Feasibility study
Cognition
Chemotherapy
Neoplasms
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Belfast Health and Social Care Trust
name: Cancer Research Network
First posted: 2015-10-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Feasibility of intervention implementation
timeFrame: After 27 weeks
Secondary outcomes:
measure: Hopkins Verbal Learning Test
timeFrame: 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).
measure: Reitan's Trail Making Test (TMT) A and B
timeFrame: 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).
measure: Controlled oral Word Association (COWA) sub-test of the Multilingual Aphasia Examination
timeFrame: 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).
measure: Neuropsychological Assessment Battery Digit Span sub-test
timeFrame: 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).
measure: STROOP test
timeFrame: 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).
measure: Functional Assessment of Cancer Therapy- Cognitive Subscale (FACT-Cog)
timeFrame: 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).
measure: Short form health survey (SF-36)
timeFrame: 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).
measure: Centre for Epidemiological studies Depression- Revised scale (CESD-R)
timeFrame: 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).
measure: Hospital Anxiety and Depression Scale- Anxiety sub-scale (HADS-A)
timeFrame: 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).
measure: Functional Assessment of Chronic Illness Therapy- Fatigue sub-scale (FACIT-F)
timeFrame: 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).
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 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).
measure: Cognitive Reserve Scale
timeFrame: Before Chemotherapy
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Cancer Centre, City Hospital, Belfast HSC Trust
state: Antrim
Study officials:
affiliation: Queen's University, Belfast
name: Michael Donnelly, PhD
role: PRINCIPAL_INVESTIGATOR
References: