An Intervention Programme to Reduce Cognitive Impairment Due to Cancer

Queen's University Belfast

Status: Terminated

Conditions: Breast Neoplasms; Colorectal Neoplasms

Treatments: Behavioral: Countering cognitive impairment

Study type: Interventional

Funder types: Other

Identifiers

NCT02581709

STL/5086/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Countering cognitive impairment

Experimental group

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.

Treatment:

Behavioral: Countering cognitive impairment