- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT06545045
Reabilitação cognitiva após tratamento do câncer de mama
Teste piloto de treinamento de estratégia metacognitiva para abordar o comprometimento cognitivo relacionado ao câncer no câncer de mama
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Anna E. Boone, PhD, OTR/L
- Número de telefone: 5738827023
- E-mail: booneae@umsystem.edu
Estude backup de contato
- Nome: Juliana H. Earwood, OTD, OTR/L
- Número de telefone: 5738846681
- E-mail: jmhudson@health.missouri.edu
Locais de estudo
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Missouri
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Columbia, Missouri, Estados Unidos, 65211
- Recrutamento
- University of Missouri
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Contato:
- Anna E Boone
- Número de telefone: 5738827023
- E-mail: booneae@umsystem.edu
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Contato:
- Juliana H Earwood
- Número de telefone: 5738846681
- E-mail: jmhudson@health.missouri.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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. |
|
Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Feasibility measures
Prazo: 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
Prazo: 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
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Cognitive Failures Questionnaire (CFQ)
Prazo: 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)
Prazo: 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)
|
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Trail Making Test (TMT)
Prazo: 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)
Prazo: 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)
Prazo: Pre-intervention (week 0) and post-intervention (week 12)
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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)
Prazo: 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)
Prazo: Pre-intervention (week 0) and post-intervention (week 12)
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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)
Prazo: 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)
Prazo: Pre-intervention (week 0) and post-intervention (week 12)
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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)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anna E Boone, PhD, OTR/L, University of Missouri Occupational Therapy
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2101565
- 1R21CA286404 (Concessão/Contrato do NIH dos EUA)
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