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An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer Survivors

2 de fevereiro de 2018 atualizado por: NYU Langone Health

An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer

The main goal of this project is to identify and remediate the cognitive difficulties, including processing speed and attention deficits in individuals who have undergone chemotherapy treatment. Recent research has demonstrated objective cognitive deficits following chemotherapy and that it is not an emotional reaction to the cancer diagnosis as it was once considered. There are a large number of woman diagnosed and treated for breast cancer that experience chemotherapy induced cognitive deficits.

Subjects who participate in the study will be evaluated for cognitive abilities prior to chemotherapy treatment and after completion of chemotherapy. Participants will then have the option to participate in the second phase of the study, which involves the use of a computer-based Brain Fitness Program for 12 weeks. This is followed by another cognitive evaluation.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

11

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • New York
      • New York, New York, Estados Unidos, 10016
        • NYU Perlmutter Cancer Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  1. Diagnosis of breast cancer with adjuvant chemotherapy treatment
  2. all subjects will be between the ages of 18 and 70 years old
  3. free from significant psychiatric history
  4. free of current alcohol or drug abuse.
  5. All participants need to understand and read English and have the capacity to consent.

Exclusion Criteria:

  1. Individuals with pre-exiting neurological disorder (i.e. brain tumors, dementia, Parkinson's disease, multiple sclerosis, seizure disorder) or diagnosed with metastasis cancer.
  2. Individuals younger than 18 years old and older than 70 years old will also be excluded due to developmental changes that occur in those years.
  3. Individuals with a current substance use disorder will also be excluded.
  4. Individuals who lack the capacity to consent will be excluded from this study.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Breast cancer patients receiving chemotherapy treatment
Outro: Brain Fitness Program (BFP)
The program is designed to improve processing speed of auditory information and attention. The BFP is comprised of six computerized subtests that continuously adjust in the level of difficulty to maintain an 85% correct response rate. The subtest exercises include discrimination of confusable syllables, recognition of sequences of syllables, matching pairs of confusable syllables, reconstruction of sequences of verbal instructions and identification of details in a verbally presented story. Participants will participate in 40 one-hour training sessions over a 12 week period to complete all cognitive remediation training sessions. Since this intervention is presented both visually and verbally, noise cancelling headphones will be provided to the participants.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Wechsler Test of Adult Reading (WTAR)
Prazo: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
The WTAR is a measure that reliably estimates levels of intelligence by asking the subject to read aloud the words on an established reading list.
Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Processing Speed (PS)
Prazo: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
1) The Paced Auditory Serial Addition Test (PASAT), which assesses complex mental manipulation of verbally presented single digit numbers. The task requires the participant to mentally add and verbally express the last two numbers presented. There are 60 trials in each of the two sets of numbers that are presented at two different speeds; 2) Symbol-Digit Modality Test requires that the subject copies numbers that are paired with symbols within a specified time limit. The coding subtest involves processing speed, short term visual memory, psychomotor speed, visual perception and visual scanning ability. 3) The Stroop Test has three parts to it: the first task requires the participant to respond to every word as quickly as possible that is presented on the computer screen. The second task requires a response when the color word matches the meaning of the word. The third task requires a response when the color of the word does not match the meaning of the word.
Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Executive Functions
Prazo: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
The Trail Making Test, Part A & B: are measures of visual search efficiency and set shifting while alternating between letters and numbers. Additionally, the Verbal Fluency subtest of the Delis-Kaplan Executive Functioning Scale (D-KEFS) will be used to measure semantic and phonemic fluency through a task of word naming, where subjects are asked to list as many words as they can within 60-second time limit that begin with a specific letter (i.e., F, A, and S), and a task of category naming, where subjects are asked to list as many words as they can within 60-second time limit that fall within a specified category (i.e., animals and boy's names), respectfully. This subtest also measures category switching ability via a task where subjects are asked to list as many words as they can within 60-second time that fall within two alternating categories (i.e., fruits/furniture).
Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Working Memory and Attention
Prazo: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
1) Digit-Span Task, this is a standardized measure of verbal working memory in which participants recall a string of numbers that are verbally presented. 2) The Continuous Performance subtest of the CNS Vital Signs neurocognitive battery. The Continuous Performance test assesses sustained attention and reaction time to targets presented on the computer by requiring the participant to respond only when a specific designated letter is presented during a 5 minute trial. 3) The Shifting Attention subtest of the CNS- Vital Signs neurocognitive battery will be administered to assess the participant's ability to maintain attention while switching between sets of target. 4) Four-Parts Continuous performance subtest of the CNS Vital Signs neurocognitive battery, which is a measure of working memory and sustained attention.
Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Visual and Verbal Memory
Prazo: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Verbal memory will be assessed with the California Verbal Learning Test (CVLT-II) which assesses learning and rote memory of verbal material. Subjects are verbally presented with a list of words that are assessed immediately and after a 20-minute delay with and without cues. The short form version of this test will be used. The Visual Memory subtest of the CNS- Vital Signs neurocognitive battery will be administered to assess non-verbal memory of immediate and delayed recall.
Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Depression
Prazo: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Beck Depression Inventory -II: This is a standardized instrument for the assessment of depression with a self-report questionnaire. Participants will endorse the level of disturbance which best describe their mood over 21 items that are characteristic of depression.
Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Anxiety
Prazo: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Beck Anxiety Inventory (BAI): The BAI is a self-report instrument for the assessment of anxiety. The BAI consists of 21 items, each describing a common symptom of anxiety on which the respondent rates how much they have been bothered by the symptoms over the last week.
Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Frontal Systems Behavior Scale (FRSBE)
Prazo: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
A validated self-report of three frontal systems behavioral syndromes: apathy, disinhibition, and executive dysfunction.
Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Cognitive Self-Report Questionnaire (CSRQ)
Prazo: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
A validated self-report questionnaire that assesses perceptions of cognition and mood related to everyday experiences for the past two weeks
Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Functional Assessment of Cancer Therapy-Cognitive Scale (FACT-Cog)
Prazo: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Measures patient's perceived cognitive functioning as a result of their diagnosis and cancer therapy.
Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
Change in Functional Assessment of Cancer Therapy - Fatigue scale (FACIT-F)
Prazo: Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
A measure of one's perception of their level of Fatigue as a result to cancer therapy.
Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

NYU Langone Health

Investigadores

  • Investigador principal: Gerald Voelbel, PhD, New York University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de setembro de 2013

Conclusão Primária (Real)

1 de agosto de 2016

Conclusão do estudo (Real)

1 de janeiro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

28 de julho de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de agosto de 2015

Primeira postagem (Estimativa)

4 de agosto de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de fevereiro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de fevereiro de 2018

Última verificação

1 de fevereiro de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 13-00146

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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