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Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue (PEI)

27 de julho de 2020 atualizado por: William H. Redd, Icahn School of Medicine at Mount Sinai

Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue During Hematopoetic Stem Cell Transplantation for Multiple Myeloma

A sample of 60 patients scheduled for HSCT in the treatment of MM will be recruited in the weeks to months prior to their hospitalization. Light therapy incorporating ambient Programmed Environmental Illumination (PEI) will be used in patient hospital rooms (during scheduled transplant) to control cancer-related fatigue (CRF). The FDA has certified that light therapy, like that used in this study, is a low-risk intervention. When admitted to the hospital for a stem cell transplant, there will be a light fixture in the hospital room which the researchers will be testing to see how it may affect cancer related fatigue, sleep quality, and other negative side effects often seen with the transplant and subsequent treatment. The light fixture will turn on and off by itself in the morning. There are two treatment arms used in the study, each of the arms uses different light intensities. The study treatment received, i.e. which of the two lights, will be chosen by chance, like flipping a coin. There is an equal chance of being given each study treatment. Participants will not be told which study treatment they are getting until after the study is completed. Each light will be turned on from 7 AM to 10AM every day during transplantation. While in the hospital, assessment of fatigue, sleep activity, depression, circadian rhythms, and quality of life will continue through the course of hospitalization (14-21 days of treatment, to determine immediate impact of sPI), then repeat at one month and three months post-discharge follow-ups (to determine lasting effects). Outcomes will be assessed through standardized scales (e.g., FACIT-Fatigue Scale) and objective measures (e.g., actigraphy, daysimeter for light monitoring, melatonin from urine collection, blood inflammatory markers, all explained below). This trial will: 1) be the first randomized clinical trial (RCT) to investigate the effects of sPI to prevent CRF and other biopsychosocial side effects of transplant; 2) focus on a distinct, relatively homogenous patient population (MM-HSCT patients) with high prevalence of CRF; and 3) explore possible circadian rhythm mediation via melatonin analysis and blood analysis. This investigation will have major public health relevance as it will determine if an inexpensive and low patient burden intervention (sPI) is able to control fatigue associated with medical illnesses and related problems.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

73

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, 10029
        • Icahn School of Medicine at Mount Sinai

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

21 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Who will undergo their first autologous HSCT procedure as treatment for multiple myeloma

AND:

  • Who are currently 21 years of age or older
  • English language proficient
  • Able to provide informed consent

Exclusion Criteria:

  • Under age 21
  • Previous HSCT procedure (autologous or allogeneic)Pregnancy
  • Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or retina damage)
  • Secondary cancer diagnosis within the last 5 years
  • Severe sleep disorders (e.g., Narcolepsy)
  • History of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
  • Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months)
  • Previous use of light therapy to alleviate fatigue or depressive symptoms

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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: PEI Experimental Light
Ambient light fixture installed in the patient's hospital room
Dispositivo: PEI Experimental Light
Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
Comparador Ativo: Comparison Light
Ambient light fixture installed in the patient's hospital room
Dispositivo: Comparison Light
Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
FACIT-Fatigue Scale
Prazo: Baseline, Day 2, 7, 14, 28 and 90
The FACIT-Fatigue scale is a13 item scale, full scale 0-52, with higher score indicating better functioning or less fatigue.
Baseline, Day 2, 7, 14, 28 and 90

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Multidimensional Fatigue
Prazo: up to 3 months
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Tested for its psychometric properties in cancer patients receiving radiotherapy, patients with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians, it was found to have good Test-retest Reliability (r=0.80) and great Internal Consistency (Cronbach's alpha = 0.92).
up to 3 months
The Pittsburgh Sleep Quality Index
Prazo: Baseline, Day 30 and Day 90
The Pittsburgh Sleep Quality Index consists of 19 self-rated instrument full scale from 0-21, with higher score indicating poorer sleep quality.
Baseline, Day 30 and Day 90
SF-36 Scale
Prazo: Baseline and 30 days post hospital discharge
Quality of life assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Baseline and 30 days post hospital discharge
Number of Participants With Score 16 or Greater on CES-D (Center for Epidemiologic Studies Depression Scale)
Prazo: Baseline, Day 2, Day 7, and Day 14 post transplant
Number of participants with score 16 or greater on CES-D, 20 item questionnaire that reflects major dimensions of depression: depressed mood; feelings of guilt and worthlessness; feelings of helplessness and hopelessness; psychomotor retardation; loss of appetite; and sleep disturbance. Full score from 0- 20, with higher score indicating more symptomology.
Baseline, Day 2, Day 7, and Day 14 post transplant
CES-D (Center for Epidemiologic Studies Depression Scale)
Prazo: Baseline, Day 2, 7, 14, 28, and 90
CES-D, 20 item questionnaire that reflects major dimensions of depression: depressed mood; feelings of guilt and worthlessness; feelings of helplessness and hopelessness; psychomotor retardation; loss of appetite; and sleep disturbance. Full score from 0- 20, with higher score indicating more symptomology.
Baseline, Day 2, 7, 14, 28, and 90
The Positive and Negative Affect Schedule (PANAS)
Prazo: Baseline, Day 30, Day 90
PANAS is a 20-item self-report measure of positive and negative affect. Each item rated on a 5-point scale of 1 (not at all) to 5 (extremely), each subscale from 1-5, full score from 1-5, with higher score indicating more symptoms. Change in PANAS at Day 30 and Day 90 as compared to baseline.
Baseline, Day 30, Day 90
Change in Brief Symptoms Inventory-18 (BSI-18)
Prazo: Baseline and Day 90
Brief Symptom Inventory-18 (BSI-18) - self-report 18-item instrument. Raw scores on the BSI-18 are converted to t-scores based on gender-specific normative data from non-patient community dwelling U.S. adults. A T-score = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating more symptom.
Baseline and Day 90
Fatigue Line Scale
Prazo: baseline, day 2, 7, and 14
Simple numeric graphic rating scale, marked on a line numbering 0-100, with higher score indicating more fatigue. Replaces the FACIT fatigue scale for daily fatigue assessment during inpatient procedures.
baseline, day 2, 7, and 14
Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)
Prazo: Baseline, Day 30 after Discharge, Day 90 after Discharge
Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF) is a 30-item short form of the MFSI that measures five dimensions: general, physical, emotional, mental fatigue, and vigor. Each item is rated on a five-point Likert scale from 0 (not at all) to 4 (extremely). The total MFSI-SF score ranges from 0-4, with a higher score indicating a higher fatigue level.
Baseline, Day 30 after Discharge, Day 90 after Discharge
Sleep Latency
Prazo: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep latency measured by actigraph - Sleep latency is the average period of time between bed time and sleep start time
Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep Efficiency
Prazo: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep efficiency measured by actigraph - Sleep efficiency is defined as the average percentage of time in bed actually spent sleeping
Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Wake Time
Prazo: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Wake time measured by actigraph. Wake time is the average number of minutes the participant spent awake each night during the 5 day period. Baseline assessments were taken before transplant and day 2 is two days after transplant which is at least one week after the baseline.
Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Wake Percent
Prazo: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Wake percent measured by actigraph - Wake percent is the average percent of each night spent awake
Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep Time
Prazo: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep time measured by actigraph. Sleep time - average number of minutes the participant was asleep each night during the 5 day period. Baseline assessments were taken before transplant and day 2 is two days after transplant which is at least one week after the baseline.
Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep Percent
Prazo: Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Sleep percent measured by actigraph. Sleep percent is the percent of time spent in bed that the participant is asleep.
Baseline, Day 2, Day 7, 3rd day post Engraftment, Discharge
Melatonin
Prazo: Baseline and Discharge
Melatonin level
Baseline and Discharge

Colaboradores e Investigadores

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

Patrocinador

Icahn School of Medicine at Mount Sinai

Publicações e links úteis

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Links úteis

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)

22 de julho de 2016

Conclusão Primária (Real)

23 de janeiro de 2019

Conclusão do estudo (Real)

23 de janeiro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

21 de junho de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de junho de 2017

Primeira postagem (Real)

26 de junho de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de agosto de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de julho de 2020

Última verificação

1 de julho de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • GCO 15-2009

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

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

Sim

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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