Metacognitive Strategy Training in Cancer-related Cognitive Impairment

NCT05505045 | Completed Results DMC

• 1 other identifier: 2066383
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

cancer; metacognition; cognition; Telehealth; activities of daily living

Outcome Measures

Primary Outcomes (7)

• Telehealth Usability Questionnaire (TUQ)

  Measure of telehealth usability from participant's perspective. Specifically, the TUQ measures usefulness and utility of technologies including usefulness, ease of use, effectiveness, reliability, and satisfaction. The TUQ uses a self-report Likert scale of 1 (disagree) to 7 (agree).

  After study completion, an average of 14 weeks

• 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

• 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

• 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

• Canadian Occupational Performance Measure (COPM) Trained Goal Performance

  Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

  Pre-intervention (week 0) and post-intervention (week 14)

• NeuroQoL Cognitive Function Short Form

  Self-report measure of cognitive ability in daily life activity. Maximum = 5 (never), Minimum = 1 (Very often/several times per day). The total raw score range is 8-40. The t-score is reported with a mean of 50 and standard deviation of 10. Higher scores mean fewer perceived cognitive challenges.

  Pre-intervention (week 0) and post-intervention (week 14)

• Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction

  Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.

  After study completion, an average of 14 weeks

Secondary Outcomes (6)

• Functional Assessment of Cancer Therapy-Breast (FACT-B)

  Pre-intervention (week 0) and post-intervention (week 14)

• Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest

  Pre-intervention (week 0) and post-intervention (week 14)

• Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest

  Pre-intervention (week 0) and post-intervention (week 14)

• Brief Visuospatial Memory Test -Revised Trial 1

  Pre-intervention (week 0) and post-intervention (week 14)

• Paced Auditory Serial Addition Test

  Pre-intervention (week 0) and post-intervention (week 14)

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: CO-OP Procedures

Attention Control Group

ACTIVE COMPARATOR

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.

Behavioral: Attention Control Procedures

Interventions

CO-OP Procedures BEHAVIORAL

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.

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

Attention Control Procedures BEHAVIORAL

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.

Attention Control Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Occupational Therapy Department

Columbia, Missouri, 65203, United States

Location

Related Publications (8)

• 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.

  PMID: 22658913 BACKGROUND

• 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.

  PMID: 23483375 BACKGROUND

• 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.

  PMID: 19472296 BACKGROUND

• 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.

  PMID: 19813133 BACKGROUND

• 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.

  PMID: 11128897 BACKGROUND

• 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.

  PMID: 21440699 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 27449501 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Anna Boone, PhD
• Organization: University of Missouri

booneae@umsystem.edu

573-882-7023

Study Officials

• Anna E Boone, PhD, OTR/L

  University of Missouri Occupational Therapy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcomes assessors will be blinded to participant study group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: October 11, 2022
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: December 16, 2024
• Results First Posted: December 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)