- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01565980
Mindfulness Therapy for Individuals With Lung Cancer
A Mindfulness Intervention for Symptom Management in Lung Cancer
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Illinois
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Chicago, Illinois, Estados Unidos, 60208
- Northwestern University
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Michigan
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East Lansing, Michigan, Estados Unidos, 48824
- Michigan State University
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Jackson, Michigan, Estados Unidos, 49201
- Allegiance Health
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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:
- Able to understand and speak English
- at least 21 years old
- active treatment for a diagnosis of non-small cell lung cancer
- Karnofsky score > 80
- have a telephone by which they can be reached
Exclusion Criteria:
- current substance abuse other than tobacco
- active treatment for psychiatric disorders excluding depression, and/or use of antipsychotic medications that would impede study participation.
- cognitive impairment
- active participation in mindfulness-based classes, guided imagery, yoga, or relaxation therapy courses
- diagnosis of small cell lung cancer
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: symptom assessment
6 weeks of symptom assessment phone calls.
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attention control receives a weekly symptom assessment phone interview for 6 weeks.
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Experimental: Mindfulness intervention
Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.
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attention control receives a weekly symptom assessment phone interview for 6 weeks.
Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
M.D. Anderson Symptom Inventory (MDASI)
Prazo: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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Symptom Severity and interference were measured with the M.D. Anderson Symptom Inventory (MDASI) .
The MDASI is a multisymptom patient-reported outcome measure.
The MDASI has 13 core items include symptoms found to have the highest frequency and/or severity in patients with various cancers and treatment types (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness,numbness and tingling.
Patients rate the severity of each symptom "at its worst" using 0-10 numerical rating scales with 0 = "not present" and 10 = "as bad as you can imagine."
The measure includes 5 symptom interference items which ask how much all symptoms, interfere with domains (walking, work, general activity, mood, relations with others, enjoyment of life) also rated on a 0-10 scale (0 = "did not interfere"; 10 = "interfered completely").
The 13 severity (range 0 - 130) and 5 interference items (range 0 - 50) are summed.
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Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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SF-36
Prazo: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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Health-related Quality of Life (HRQOL) Indices (Physical/Emotional Function, Role Function, Pain, General Health, Vitality, Mental/Physical Health)HRQOL(SF-36) calculated using Quality Metric, Inc. an algorithm producing normal scores (1-100 range).
With normed scoring, general population has mean=50, SD=10.
For the minimum and maximum values in each of the scale ranges provided, higher values represent a better outcome.
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Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Center for Epidemiologic Studies Depression (CES-D)
Prazo: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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The score is the sum of the 20 questions.
Each item has a range of 1 - 4 for frequency of a behavior or mental state in the past week ; 1 - Rarely or none of the time (less than 1 day); 2 = Some or a little of the time (1-2 days); 3 = Occasionally or a moderate amount of time (3-4 days); 4 = Most or all of the time (5-7 days).
Possible range is 0-60.
There are 4 reverse-scored items (questions 4, 8, 12, and 16).
A score of 16 points or more is considered depressed.
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Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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Cancer Dyspnea Scale
Prazo: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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The cancer dyspnea scale (CDS) has 12 Likert scale items ( 1 = Not at all, 5 = Very much) that ask questions about breathlessness or difficulty in breathing during the past few days. The CDS has an overall score (range 0-42) and 3 subscales that measure the amount of effort with breathing, anxiety associated with breathing, and discomfort associated with breathing. The 3 subscales are calculated by: 1) effort (items 4+6+8+10+12) - 5 [range 0 (no dyspnea effort)-20 (worst dyspnea effort)]; 2) anxiety (items 5+7+9+11) - 4 [range 0 (no dyspnea anxiety) - 16 (worst dyspnea anxiety)]; 3) discomfort [15 - (items 1+2+3) {range 0 (no dyspnea discomfort) - 12 (worst dyspnea discomfort)}]. The total dyspnea score is derived by adding the total subscale scores. The subscale score subtractions are to make adjustments for 0 as a state of absence of dyspnea (thus total dyspnea summary scores range from 0 to 42). |
Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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Worry (Cancer-related and General)
Prazo: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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Both cancer-related and general worry were measured with 3 item scales.
Cancer-related worry had three statements asking about level of worry related to diagnosis, treatment, and worry interference using a 1 = "not at all" to 5 = "most or all the time" scale, range 3-15.
Items are summed.
General worry used an abbreviated brief Penn State Worry questionnaire with 3 statements that measure how typical that statements are in describing the person.
Uses a 3 item scale with 1 = "not at all typical" to 5 = "very typical".
the range is 3-15.
Items are summed.
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Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)
Prazo: Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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The PSSQ_I has 13 self rated questions.
The first 5 items, used to determine sleep quality (presence; frequency of insomnia problems) are rated [0 = never to 5 = always, 5-7 days per week; (range 0-25)] and items 6 to 13 are aimed at identifying the degree of interference experienced from sleep impairment (rated 0=not at all to 4=extremely on Likert scale; range 0 - 32).
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Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.
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Baseline Values for All Measures.
Prazo: Baseline.
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Description of all measures are described elsewhere.
Provided are the means and standard deviations for baseline comparisons.
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Baseline.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rebecca Lehto, PhD, Michigan State University
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- CTSI grant
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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