Metacognitive Strategy Training in Cancer-related Cognitive Impairment

University of Missouri (MU)

Status: Completed

Conditions: Breast Cancer Female

Treatments: Behavioral: Attention Control Procedures; Behavioral: CO-OP Procedures

Study type: Interventional

Funder types: Other

Identifiers

NCT05505045

2066383

Details and patient eligibility

About

The first aim of this study is to determine the feasibility of delivering CO-OP remotely to breast cancer survivors, who self-report cancer-related cognitive impairment (CRCI), in preparation for a future R01 trial. The second aim of this study is to assess the effect of CO-OP on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI. The research team hypothesizes that effect size estimations will indicate that CO-OP will have a greater positive effect, compared to attention control, on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI.

Full description

Breast cancer survivors often self-report cognitive changes after treatment for cancer (e.g. cancer-related cognitive impairment (CRCI)). These cognitive changes have a devastating impact on everyday life activities, such as work/productivity, community involvement, driving, and financial management. While CRCI would likely be amenable to rehabilitation services, breast cancer survivors face two primary barriers to adequate rehabilitation, including (1) inadequate access to rehabilitation services, and (2) limited effective interventions to address CRCI.

Breast cancer survivors have inadequate access to rehabilitation services to address CRCI. A recent report sponsored by the National Cancer Institute (NCI) concluded that most NCI-designated cancer centers do not have integrated cancer rehabilitation services. Even if comprehensive rehabilitation services were provided by these centers, millions of cancer survivors live in rural areas outside close proximity to a cancer center and are more likely to experience poorer outcomes compared to urban counterparts. If rehabilitation services were provided, proximity to facilities may be a limiting factor in individuals from rural communities receiving rehabilitative care. Access to services has been further curtailed amid the COVID-19 pandemic, with calls building from national organizations for improvements in remote delivery of services.

Metacognitive strategy training (MCST) is a practice standard to address cognitive impairment in other conditions, such as traumatic brain injury and stroke. The Cognitive-Orientation to daily Occupational Performance (CO-OP) approach is a MCST intervention in which subjects are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to engage in an activity. The investigators' preliminary data suggest that CO-OP may have a positive impact on activity performance, subjective and objective cognition, and quality of life in breast cancer survivors with CRCI. While current evidence supports the remote delivery of strategy-based interventions like CO-OP, this intervention has not been evaluated in breast cancer survivors with CRCI.

The investigators' overall research hypothesis is that CO-OP can feasibly be administered remotely and will improve activity performance, subjective and objective cognition, and subjective quality of life in breast cancer survivors with CRCI.

Enrollment: 46 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• self-reported CRCI (Cognitive Failures Questionnaire (CFQ) score >30)
• completed full course of chemotherapy at least 6 months, but no later than 3 years, prior to participation
• able to read, write, and speak English fluently
• able to provide valid informed consent
• have a life expectancy of greater than 6 months at time of enrollment
• diagnosed with breast cancer (invasive ductal or lobular BrCA Stages I, II, or III) and completed chemotherapy within the preceding three years
• on stable doses of medications (i.e., no changes in past 60 days)

Exclusion criteria

• prior cancer diagnoses of other sites with evidence of active disease within the past year
• active diagnoses of any acute or chronic brain-related neurological conditions that can alter normal brain function (e.g., Parkinson's disease, dementia, cerebral infarcts, traumatic brain injury)
• severe depressive symptoms (Personal Health Questionnaire (PHQ-9) score of ≥21)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Treatment Group: Cognitive Orientation to daily Occupational Performance (CO-OP)

Experimental group

Description:

Each CO-OP session will last 60 minutes and subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.

Treatment:

Behavioral: CO-OP Procedures

Attention Control Group

Active Comparator group

Description:

Each session will last 60 minutes and subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.

Treatment:

Behavioral: Attention Control Procedures