乳がん治療後の認知リハビリテーション
乳がんにおけるがん関連の認知障害に対処するためのメタ認知戦略トレーニングのパイロットテスト
The goal of this proposed project is to evaluate the feasibility and preliminary effect of metacognitive strategy training to improve activity performance, cognition, and quality of life in breast cancer survivors with cancer-related cognitive impairment (CRCI). The other goal of this proposed project is to examine the effects of CO-OP on resting (rsFC)- and task-state functional connectivity as compared to an inactive control group.
調査の概要
詳細な説明
Breast cancer survivors often self-report cognitive deficits, primarily in executive functioning (planning, problem solving, multitasking), memory, and processing speed after cancer treatment, i.e., cancer-related cognitive impairment (CRCI). The prevalence of CRCI following breast cancer is as high as 78% and can persist chronically after treatment has ended. In other health conditions associated with cognitive impairment, such as traumatic brain injury, the only evidence-based recommended practice standard for deficits in executive function is metacognitive strategy training (MCST). In this approach, participants are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to successfully engage in an activity. While the cognitive deficits identified in and described by breast cancer survivors seem quite amenable to MCST, there is no study in the published literature which measures the efficacy of MCST on CRCI. 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. Preliminary data suggest that CO-OP may have a positive impact on subjective and objective cognitive performance in breast cancer survivors with CRCI. Further, this study will evaluate the neurophysiological underpinnings associated with treatment changes through the use of neuroimaging methods.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Anna E. Boone, PhD, OTR/L
- 電話番号:5738827023
- メール:booneae@umsystem.edu
研究連絡先のバックアップ
- 名前:Juliana H. Earwood, OTD, OTR/L
- 電話番号:5738846681
- メール:jmhudson@health.missouri.edu
研究場所
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Missouri
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Columbia、Missouri、アメリカ、65211
- 募集
- University of Missouri
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コンタクト:
- Anna E Boone
- 電話番号:5738827023
- メール:booneae@umsystem.edu
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コンタクト:
- Juliana H Earwood
- 電話番号:5738846681
- メール:jmhudson@health.missouri.edu
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- self-reported CRCI (Global Rating of Cognition dysfunction as "Moderately" "Strongly "or "Extremely" AND a Cognitive Failures Questionnaire1 (CFQ) score >30)
- completed treatment for active cancer diagnosis (invasive ductal or lobular BrCA Stages I, II, or III) at least 6 months but not greater 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
- on stable doses (i.e., no changes in past 90 days) of medications that are known to impact cognitive function (i.e., anti-depressants)
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 anatomy or function (e.g., Parkinson's disease, dementia, cerebral infarcts) dementia symptoms as indicated by a score of <23 on the Montreal Cognitive Assessment (MoCA)
- severe depressive symptoms (Personal Health Questionnaire-9 (PHQ-9) score of ≥21)
- history of severe traumatic brain injury, prolonged loss of consciousness (e.g., coma)
- conditions contraindicated for MRI (e.g., electrical implants, pumps, claustrophobia)
- blue-yellow colorblindness
- pregnancy
The screening methods identified in parentheses next to appropriate inclusion/exclusion criteria will be used to verify appropriate selection of study participants.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Metacognitive strategy training (MCST)
Each MCST session will be follow the procedures of Cognitive Orientation to daily Occupational Performance (CO-OP) intervention. There will be 10, 45-minute, weekly sessions. All sessions will be delivered in-person with a trained occupational therapist. |
The MCST group will follow procedures for the Cognitive Orientation to daily Occupational Performance intervention. First, five functional, everyday life goals are identified collaboratively by the participant and interventionist. In the second meeting, the therapist introduces the approach to the subject and teach a 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. |
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アクティブコンパレータ:Inactive Control Group
Participants will receive a weekly phone call from study staff to maintain contact and monitor changes in activity. |
Weekly contact will be made via telephone call to (1) maintain study engagement, (2) introduce weekly social contact with researchers, mimicking some of the potential incidental effects of the experimental group, and (3) ascertain what, if any, additional steps participants have taken to reduce cognitive symptoms. The content of each of these meetings will be tracked in intervention notes. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility measures
時間枠:After study completion, an average of 12 weeks
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Recruitment rate, retention rate |
After study completion, an average of 12 weeks
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Canadian Occupational Performance Measure (COPM) Performance
時間枠:Pre-intervention (week 0) and post-intervention (week 12)
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Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance. |
Pre-intervention (week 0) and post-intervention (week 12)
|
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Canadian Occupational Performance Measure (COPM) Satisfaction
時間枠:Pre-intervention (week 0) and post-intervention (week 12)
|
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance. |
Pre-intervention (week 0) and post-intervention (week 12)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cognitive Failures Questionnaire (CFQ)
時間枠:Pre-intervention (week 0) and post-intervention (week 12)
|
Self-report measure of lapses in motor function memory and perception. This questionnaire contains 25 items and scores range from 0 to 100. Higher scores = greater perceived impairment. |
Pre-intervention (week 0) and post-intervention (week 12)
|
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Dysexecutive Questionnaire (DEX)
時間枠:Pre-intervention (week 0) and post-intervention (week 12)
|
Self-report measure of the functional impact of executive dysfunction. It consists of 20 items within four domains: (1) emotional, (2) motivational, (3) behavioral, and (4) cognitive. Each item is rated for frequency using a 5-point Likert scale ranging from 0 (never) to 4 (very often). |
Pre-intervention (week 0) and post-intervention (week 12)
|
|
Trail Making Test (TMT)
時間枠:Pre-intervention (week 0) and post-intervention (week 12)
|
Part A is an attention, visual search, and motor speed task that involves connecting a series of numbers in ascending order. Part B requires alternating between numbers and letters to assess set shifting and executive abilities. |
Pre-intervention (week 0) and post-intervention (week 12)
|
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Controlled Oral Word Association (COWA)
時間枠:Pre-intervention (week 0) and post-intervention (week 12)
|
Measure of verbal fluency that requires spontaneous word production for a different letter of the alphabet across three different trials. |
Pre-intervention (week 0) and post-intervention (week 12)
|
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The Activity Card Sort (ACS)
時間枠:Pre-intervention (week 0) and post-intervention (week 12)
|
Self-report measure of participation in various everyday life activities that are in the categories of low demand leisure, high demand leisure, instrumental activities of daily living, and social activity. Cards are sorted according to if the subject is performing each activity as much, less than, or more as compared to before experiencing cancer-related cognitive impairment. |
Pre-intervention (week 0) and post-intervention (week 12)
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Functional Assessment of Cancer Therapy-Breast (FACT-B)
時間枠:Pre-intervention (week 0) and post-intervention (week 12)
|
A quality-of-life measure across five domains: Physical, social, emotional, functional well-being, and breast-cancer subscale. |
Pre-intervention (week 0) and post-intervention (week 12)
|
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Participation Strategies Self Efficacy Scale (PS-SES)
時間枠:Pre-intervention (week 0) and post-intervention (week 12)
|
Self-report measure of self-efficacy in using participation strategies. The subject rates confidence across 35 items within six subscales: (1) managing home participation, (2) staying organized, (3) planning and managing community participation, (4) managing work and productivity), (5) managing communication, and (6) advocating for resources. |
Pre-intervention (week 0) and post-intervention (week 12)
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Paced Auditory Serial Addition Test (PASAT)
時間枠:Pre-intervention (week 0) and post-intervention (week 12)
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Measure of working memory and attention in which a series of single digit numbers are presented audibly individuals. The most recent two digits are to be summed prior to the next digit presented. Two commonly used subversions use a 2 second or 3 second inter-stimulus interval. |
Pre-intervention (week 0) and post-intervention (week 12)
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Hopkins Verbal Learning Test-Revised (HVLT-R)
時間枠:Pre-intervention (week 0) and post-intervention (week 12)
|
Measure of verbal learning and memory in which a list of 12 words is to be recalled. Three learning trials with free recall followed by a delayed recall at 20 minutes and a recognition trial. |
Pre-intervention (week 0) and post-intervention (week 12)
|
協力者と研究者
捜査官
- 主任研究者:Anna E Boone, PhD, OTR/L、University of Missouri Occupational Therapy
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- Schagen SB, Wefel JS. Chemotherapy-related changes in cognitive functioning. EJC Suppl. 2013 Sep;11(2):225-32. doi: 10.1016/j.ejcsup.2013.07.007. No abstract available.
- Myers JS. Chemotherapy-related cognitive impairment. Clin J Oncol Nurs. 2009 Aug;13(4):413-21. doi: 10.1188/09.CJON.413-421.
- Janelsins MC, Kohli S, Mohile SG, Usuki K, Ahles TA, Morrow GR. An update on cancer- and chemotherapy-related cognitive dysfunction: current status. Semin Oncol. 2011 Jun;38(3):431-8. doi: 10.1053/j.seminoncol.2011.03.014.
- Janelsins MC, Kesler SR, Ahles TA, Morrow GR. Prevalence, mechanisms, and management of cancer-related cognitive impairment. Int Rev Psychiatry. 2014 Feb;26(1):102-13. doi: 10.3109/09540261.2013.864260.
- Haskins E. Cognitive Rehabilitation Manual: Translating Evidence-Based Recommendations into Practice. vol 1. American Congress of Rehabilitation Medicine; 2012.
- Wefel JS, Schagen SB. Chemotherapy-related cognitive dysfunction. Curr Neurol Neurosci Rep. 2012 Jun;12(3):267-75. doi: 10.1007/s11910-012-0264-9.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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