Metacognitive Strategy Training in Cancer-related Cognitive Impairment

Breast Cancer Female Clinical Trial

Official title:

Feasibility of Using Remotely-delivered Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05505045
• Other study ID #: 2066383
• Status: Completed
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: April 4, 2024

Study information

• Verified date: May 2024
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 4, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Cognitive Dysfunction

Intervention

Behavioral:
• CO-OP Procedures
CO-OP is a metacognitive strategy training intervention that will be used in this study. First, five functional, everyday life goals are identified collaboratively by the participant and interventionist. In the second meeting, we introduce the approach to the subject and teach the global cognitive strategy (i.e., GOAL-PLAN-DO-CHECK). In all subsequent sessions, this strategy is used as the main problem-solving framework to facilitate skill acquisition.The subject identifies a GOAL, and then is guided by the therapist to discover a PLAN to potentially achieve the goal. The subject is then asked to DO the plan (if feasible during the therapy session otherwise asked to complete at home prior to the next treatment session), and subsequently to CHECK to see if the plan worked, i.e. the goal was achieved. This process is repeated until satisfactory performance is met for each established goal.
• Attention Control Procedures
Individuals in the attention control group will have dose-equivalent, weekly virtual contact through the Zoom platform for 12-weeks with a a trained interventionist not involved in CO-OP treatment. The control group will control for interpersonal interaction, maturation effects, and testing effects. The focus of each session will include: (1) social interaction characterized by warmth/empathy and (2) provision of usual care CRCI educational resources (e.g. exercise, using memory aids, minimizing distractions) from MD Anderson Cancer Center. These recommendations will be provided without further instruction. Any questions that arise regarding CRCI the subject is experiencing will be answered. The therapist will debrief with the subject on any changes in CRCI symptoms. The content and duration of each call will be tracked. Each session will be recorded with two randomly selected and reviewed for fidelity.

Locations

Country	Name	City	State
United States	University of Missouri Occupational Therapy Department	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View Citation

Haskins E. Cognitive Rehabilitation Manual: Translating Evidence-Based Recommendations into Practice. Vol 1. Reston, VA: American Congress of Rehabilitation Medicine; 2012.

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility measures	Recruitment rate, retention rate	After study completion, an average of 14 weeks
Primary	Telehealth Usability Questionnaire (TUQ)	Measure of telehealth usability from participant's perspective. Self-report Likert scale of 1 (disagree) to 7 (agree)	After study completion, an average of 14 weeks
Primary	Acceptability of Intervention Measure (AIM)	Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)	After study completion, an average of 14 weeks
Primary	Intervention Appropriateness Measure (IAM)	Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)	After study completion, an average of 14 weeks
Primary	Feasibility of Intervention Measure (FIM)	Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)	After study completion, an average of 14 weeks
Primary	Canadian Occupational Performance Measure (COPM)	Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.	Pre-intervention (week 0) and post-intervention (week 14)
Primary	NeuroQoL Cognitive Function Short Form	Self-report measure of cognition. Maximum = 5 (never), Minimum = 1 (Very often/several times per day). Higher scores mean fewer perceived cognitive challenges.	Pre-intervention (week 0) and post-intervention (week 14)
Secondary	Patient Health Questionnaire (PHQ-9)	Self-report measure of depressive symptoms. Minimum = 0 (not at all), Maximum = 3 (nearly every day). Higher scores indicate increased depressive symptoms.	Pre-intervention (week 0) and post-intervention (week 14)
Secondary	Functional Assessment of Cancer Therapy-Breast (FACT-B)	Self-report measure of quality of life. Domains include questions related to physical, emotional, social, and functional well-being, as well as additional concerns. Minimum = 0 (not at all), Maximum = 4 (very much). Higher scores indicate decreased perceived well-being and quality of life.	Pre-intervention (week 0) and post-intervention (week 14)
Secondary	Montreal Cognitive Assessment (MoCA)	Objective, therapist-rated measure of general cognitive function. Total score is out of 30 points, with 26 points or higher indicating normal cognition.	Pre-intervention (week 0) and post-intervention (week 14)
Secondary	Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference	Objective measure of inhibition and cognitive flexibility. Consists of 4 conditions (color naming, word reading, inhibition, and inhibition/switching). Therapist records client-corrected errors, noncorrected errors, and total time required for each domain. Increased errors and time indicate potential challenges with inhibition and cognitive flexibility.	Pre-intervention (week 0) and post-intervention (week 14)
Secondary	Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number Sequencing, Coding, Symbol Search subtests	Objective measure of inhibition, attention, working memory, and processing speed. Consists of 3 subtests (letter-number sequencing, symbol search, and coding). Increased errors and time indicate potential challenges with inhibition, attention, working memory, and processing speed.	Pre-intervention (week 0) and post-intervention (week 14)
Secondary	Brief Visuospatial Memory Test -Revised	Objective measure of episodic memory. Participant is presented with six geometric figures for 10 seconds on three different occasions, and then asked to draw the six figures on a separate sheet of paper in the correct order. Increased errors may indicate challenges with episodic memory.	Pre-intervention (week 0) and post-intervention (week 14)
Secondary	Paced Auditory Serial Addition Test	Objective measure of working memory. Participant is presented with single digits every 2-3 seconds and asked to add each digit to the one immediately prior to it. Total score is out of 60 points, with increased errors indicating challenges with working memory.	Pre-intervention (week 0) and post-intervention (week 14)
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-57) Profile v2.0	Self-reported changes in anxiety, depression, fatigue, pain, physical function, sleep, and participation. Maximum = 5, Minimum = 1. Higher scores indicate lower perceived symptoms of depression and anxiety, lower fatigue, less pain, and increased perceived independence and participation in functional activities.	Pre-intervention (week 0) and post-intervention (week 14)