Quality of Life Interventions During Cervical Cancer Treatment
25 de maio de 2021 atualizado por: Susan Lutgendorf, University of Iowa
The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side effects, and immunosuppression.
This prospective randomized clinical trial proposes to examine the effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation.
Tipo de estudo
Intervencional
Inscrição (Real)
60
Estágio
- Não aplicável
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 100 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Women with stage I-IVa cervical cancer pursuing concurrent chemotherapy and radiation therapy.
Exclusion Criteria:
- Greater than Stage IVa cervical cancer
- Metastatic or recurrent cervical cancer
- Patients receiving only chemotherapy or only radiation therapy
- History of cancer of any site
- History of a transplant
- Diagnosed with any immunosupressive disorder (HIV, AIDS).
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Relaxation training following daily radiation
All relaxation sessions will be given individually, and will be provided by trained nurses or research assistants.
Patients receiving relaxation will learn exercises to release tension through muscle relaxation, breathing, and imagery
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Muscle relaxation training
Outros nomes:
Subjects in all groups will give 4 blood samples during the study
Outros nomes:
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Experimental: Healing touch therapy following daily radiation
All Healing Touch sessions will be given individually, and will be provided by trained nurses or research assistants.
Patients receiving Healing Touch will receive a series of standardized therapeutic techniques designed to promote optimal flow of energy throughout the body.
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Subjects in all groups will give 4 blood samples during the study
Outros nomes:
Healing Touch (HT) therapy
Outros nomes:
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Comparador Ativo: No intervention
The no intervention group will receive no special intervention other than standard medical care, which includes the regular medical care given by the patient's physician and health care professionals.
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Subjects in all groups will give 4 blood samples during the study
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in natural killer cell cytotoxicity (NKCC)
Prazo: 6 weeks
|
Compare change in natural killer cell cytotoxicity of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw. Fresh peripheral blood mononuclear cells tested for cytolytic activity against the NK-sensitive K562 cells and the NK-resistant LAK-sensitive ZKBL cells in a standard 4-h 51Chromium- release assay. |
6 weeks
|
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Number of chemoradiation-related toxicities
Prazo: 6 weeks
|
Compare number of reported side effects of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care as measured by the Common Toxicity Criteria Manual Version 2.0
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6 weeks
|
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Number of days of treatment delay due to chemoradiation-related toxicities
Prazo: 6 weeks
|
Compare number of days in treatment delay due to chemoradiation-related toxicity for participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care
|
6 weeks
|
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Change in participant reports of depression
Prazo: 6 weeks
|
Compare changes in depression scores of participants receiving HT to participants receiving relaxation training or usual care during radiation and chemotherapy as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) in which higher scores indicate worse depression (range 0-60)
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6 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in participant reports of anxiety
Prazo: 6 weeks
|
Compare changes in reported anxiety of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Profile of Mood States- Anxiety Subscale (POMS-SF) (range 0-28)
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6 weeks
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Change in white blood cell counts
Prazo: 6 weeks
|
Compare change in white blood cell counts of participants receiving HT during radiation and chemotherapy vs. patients receiving relaxation training or usual care during this time hemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw. |
6 weeks
|
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Change in red blood cell counts
Prazo: 6 weeks
|
Compare change in red blood cell counts of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment collected via blood draw.
|
6 weeks
|
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Change in participant reports of quality of life
Prazo: 6 weeks
|
Compare change in reported quality of life of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Functional assessment of Cancer therapies (FACT).
Higher scores indicate better quality of life.
Range= (0-136).
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6 weeks
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Change in participant reports of fatigue
Prazo: 6 weeks
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Compare reported fatigue of participants receiving HT during radiation and chemotherapy to participants receiving relaxation training or usual care during radiation and chemotherapy treatment as measured by the Fatigue Severity Inventory (FSI).
Mean fatigue intensity (range 0-10) with higher scores indicating more fatigue, and fatigue duration in days last week experiencing fatigue (0-7 days) with greater number of days indicating greater fatigue duration.
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6 weeks
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Change in metabolomic measures
Prazo: 6 weeks
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Compare metabolic profile of participants receiving HT during radiation and chemotherapy treatment to participants receiving relaxation training or usual care.
Samples were assayed using Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectroscopy (UPLC-MS/MS).
The metabolomic profiling analysis measures the quantity of specific compounds in the plasma vs. a platform of 844 known metabolites in a commercial platform powered by Metabolon, Inc.
For any specific metabolite, higher levels indicates greater presence of the metabolite.
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6 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Susan Lutgendorf, PhD, University of Iowa
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Hart LK, Freel MI, Haylock PJ, Lutgendorf SK. The use of healing touch in integrative oncology. Clin J Oncol Nurs. 2011 Oct;15(5):519-25. doi: 10.1188/11.CJON.519-525.
- Lutgendorf SK, Mullen-Houser E, Russell D, Degeest K, Jacobson G, Hart L, Bender D, Anderson B, Buekers TE, Goodheart MJ, Antoni MH, Sood AK, Lubaroff DM. Preservation of immune function in cervical cancer patients during chemoradiation using a novel integrative approach. Brain Behav Immun. 2010 Nov;24(8):1231-40. doi: 10.1016/j.bbi.2010.06.014. Epub 2010 Jun 30.
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)
4 de junho de 2001
Conclusão Primária (Real)
15 de março de 2008
Conclusão do estudo (Real)
1 de julho de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
20 de maio de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de maio de 2021
Primeira postagem (Real)
27 de maio de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de maio de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de maio de 2021
Última verificação
1 de maio de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 200105058
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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
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