An Intervention Programme to Reduce Cognitive Impairment Due to Cancer

NCT02581709 | Terminated

• 1 other identifier: STL/5086/14
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Colorectal Neoplasms

Keywords

Feasibility study; Cognition; Chemotherapy; Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Hopkins Verbal Learning Test

  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

  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

  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

  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

  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).

Study Arms (1)

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.

Behavioral: Countering cognitive impairment

Interventions

Countering cognitive impairment BEHAVIORAL

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.

Countering cognitive impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Belfast Health and Social Care Trust: collaborator
• Cancer Research Network: collaborator

Study Sites (1)

Cancer Centre, City Hospital, Belfast HSC Trust

Belfast, Antrim, BT12, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Michael Donnelly, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Michael Donnelly

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 21, 2015
• Study Start: May 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

GB (1)