An Intervention Programme to Reduce Cognitive Impairment Due to Cancer

Breast Neoplasms Clinical Trial

Official title:

The Development and Feasibility Testing of an Intervention Programme to Reduce Cognitive Impairment Due to Cancer Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02581709
• Other study ID #: STL/5086/14
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: October 2017

Study information

• Verified date: December 2021
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Cognitive Dysfunction
• Colorectal Neoplasms
• Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United Kingdom	Cancer Centre, City Hospital, Belfast HSC Trust	Belfast	Antrim

Sponsors (3)

Lead Sponsor	Collaborator
Queen's University, Belfast	Belfast Health and Social Care Trust, Cancer Research Network

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After 27 weeks
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	Cognitive Reserve Scale	This scale is used to capture engagement in cognitive activities throughout the lifespan.	Before Chemotherapy