Clinical trial NCT05505045: Metacognitive Strategy Training in Cancer-related Cognitive Impairment
Official title: Feasibility of Using Remotely-delivered Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: cancer
metacognition
cognition
Telehealth
activities of daily living
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 46
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After baseline assessment, subjects will be randomized to one of two groups: (1) a 10-session Cognitive Orientation to daily Occupational Performance (CO-OP) intervention; or (2) a 10-session attention control group.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Telehealth Usability Questionnaire (TUQ)
timeFrame: After study completion, an average of 14 weeks
measure: Acceptability of Intervention Measure (AIM)
timeFrame: After study completion, an average of 14 weeks
measure: Intervention Appropriateness Measure (IAM)
timeFrame: After study completion, an average of 14 weeks
measure: Feasibility of Intervention Measure (FIM)
timeFrame: After study completion, an average of 14 weeks
measure: Canadian Occupational Performance Measure (COPM) Trained Goal Performance
timeFrame: Pre-intervention (week 0) and post-intervention (week 14)
measure: NeuroQoL Cognitive Function Short Form
timeFrame: Pre-intervention (week 0) and post-intervention (week 14)
measure: Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction
timeFrame: After study completion, an average of 14 weeks
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy-Breast (FACT-B)
timeFrame: Pre-intervention (week 0) and post-intervention (week 14)
measure: Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest
timeFrame: Pre-intervention (week 0) and post-intervention (week 14)
measure: Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest
timeFrame: Pre-intervention (week 0) and post-intervention (week 14)
measure: Brief Visuospatial Memory Test -Revised Trial 1
timeFrame: Pre-intervention (week 0) and post-intervention (week 14)
measure: Paced Auditory Serial Addition Test
timeFrame: Pre-intervention (week 0) and post-intervention (week 14)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities
timeFrame: Pre-intervention (week 0) and post-intervention (week 14)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Occupational Therapy Department
state: Missouri
Study officials:
affiliation: University of Missouri Occupational Therapy
name: Anna E Boone, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hutchinson AD, Hosking JR, Kichenadasse G, Mattiske JK, Wilson C. Objective and subjective cognitive impairment following chemotherapy for cancer: a systematic review. Cancer Treat Rev. 2012 Nov;38(7):926-34. doi: 10.1016/j.ctrv.2012.05.002. Epub 2012 Jun 2.
citation: O'Farrell E, MacKenzie J, Collins B. Clearing the air: a review of our current understanding of "chemo fog". Curr Oncol Rep. 2013 Jun;15(3):260-9. doi: 10.1007/s11912-013-0307-7.
citation: Reid-Arndt SA, Hsieh C, Perry MC. Neuropsychological functioning and quality of life during the first year after completing chemotherapy for breast cancer. Psychooncology. 2010 May;19(5):535-44. doi: 10.1002/pon.1581.
citation: Reid-Arndt SA, Yee A, Perry MC, Hsieh C. Cognitive and psychological factors associated with early posttreatment functional outcomes in breast cancer survivors. J Psychosoc Oncol. 2009;27(4):415-34. doi: 10.1080/07347330903183117.
citation: Cicerone KD, Dahlberg C, Kalmar K, Langenbahn DM, Malec JF, Bergquist TF, Felicetti T, Giacino JT, Harley JP, Harrington DE, Herzog J, Kneipp S, Laatsch L, Morse PA. Evidence-based cognitive rehabilitation: recommendations for clinical practice. Arch Phys Med Rehabil. 2000 Dec;81(12):1596-615. doi: 10.1053/apmr.2000.19240.
citation: Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
citation: Haskins E. Cognitive Rehabilitation Manual: Translating Evidence-Based Recommendations into Practice. Vol 1. Reston, VA: American Congress of Rehabilitation Medicine; 2012.
citation: Wolf TJ, Doherty M, Kallogjeri D, Coalson RS, Nicklaus J, Ma CX, Schlaggar BL, Piccirillo J. The Feasibility of Using Metacognitive Strategy Training to Improve Cognitive Performance and Neural Connectivity in Women with Chemotherapy-Induced Cognitive Impairment. Oncology. 2016;91(3):143-52. doi: 10.1159/000447744. Epub 2016 Jul 23.