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Individualized Education for Bortezomib-Related Symptom Management in Multiple Myeloma

19 de agosto de 2026 atualizado por: Can Lafci

Investigation of the Effect of Education Given to Patients With Multiple Myeloma on Symptom Severity

This study evaluated an individualized, nurse-delivered education program for managing treatment-related symptoms in patients with newly diagnosed multiple myeloma receiving bortezomib for the first time. A total of 40 patients participated. Twenty patients received two individual education sessions in addition to routine care, while 20 patients in the control group received routine care. The education focused on recognition, prevention, and management of common bortezomib-related symptoms, including peripheral neuropathy, pain, nausea, vomiting, diarrhea, constipation, fatigue, anemia, bleeding risk, infection risk, and dyspnea. Treatment-related symptoms were assessed before treatment and education (baseline), on day 21, and on day 63. The study aimed to evaluate whether individualized patient education was associated with differences in the occurrence and severity of treatment-related symptoms over time.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

49

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

  • Turquia (Türkiye)
    • Istanbul
      • İzmir, Istanbul, Turquia (Türkiye), 34854
        • Ege University Faculty of Medicine, Berna Türek Chemotherapy 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

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Age 18 years or older
  • Newly diagnosed with multiple myeloma
  • Scheduled to receive bortezomib 1.3 mg/m² on days 1, 4, 8, and 11
  • Able to communicate
  • Able to read and write
  • Willing to participate in the study

Exclusion Criteria:

  • Younger than 18 years
  • Presence of a disease or condition that could affect the nervous system, such as brain metastasis or diabetes
  • Cognitive impairment
  • Unstable vital signs
  • History of alcohol use
  • Communication impairment
  • Unwilling to participate in the 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: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Individualized Education Group
Participants received two individualized, nurse-delivered education sessions in addition to routine care. The education addressed recognition, prevention, and management of common bortezomib-related symptoms. Written and visual educational materials were used, and participants were encouraged to monitor symptoms and contact the researcher when needed.
Comportamental: Individualized Nurse-Delivered Education Program
The intervention consisted of two individualized education sessions delivered by the researcher using a Care and Treatment Guide for Patients and Families. The program addressed multiple myeloma and management of bortezomib-related peripheral neuropathy, pain, nausea, vomiting, diarrhea, constipation, fatigue, anemia, bleeding risk, infection risk, and dyspnea. Written and visual materials were used. The second session reinforced topics that were not fully understood, encouraged symptom monitoring with a diary, and provided telephone access to the researcher.
Sem intervenção: Routine Care Control Group
Participants received routine care during the study follow-up period without the individualized education intervention. The education booklet was provided after the final study assessment on day 63.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Motor Neuropathy Severity Assessed by NCI-CTC Version 2.0
Prazo: Baseline before treatment and education, Day 21, and Day 63
Motor neuropathy severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 motor neuropathy grading scale. Severity was graded from 0 to 4, with 0 indicating no motor neuropathy and higher grades indicating greater severity; grade 4 indicates paralysis.
Baseline before treatment and education, Day 21, and Day 63
Sensory Neuropathy Severity Assessed by NCI-CTC Version 2.0
Prazo: Baseline before treatment and education, Day 21, and Day 63
Sensory neuropathy severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 sensory neuropathy grading scale. Severity was graded from 0 to 4, with 0 indicating no sensory neuropathy and higher grades indicating greater symptom severity.
Baseline before treatment and education, Day 21, and Day 63
Abdominal Pain Severity Assessed by NCI-CTC Version 2.0
Prazo: Baseline before treatment and education, Day 21, and Day 63
Abdominal pain severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 abdominal pain grading scale. Severity was graded from 0 to 4, with 0 indicating no abdominal pain and higher grades indicating greater severity; grade 4 indicates life-threatening severity.
Baseline before treatment and education, Day 21, and Day 63
Nausea Severity Assessed by NCI-CTC Version 2.0
Prazo: Baseline before treatment and education, Day 21, and Day 63
Nausea severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 nausea grading scale. Severity was graded from 0 to 3, with 0 indicating no nausea and higher grades indicating greater symptom severity.
Baseline before treatment and education, Day 21, and Day 63
Vomiting Severity Assessed by NCI-CTC Version 2.0
Prazo: Baseline before treatment and education, Day 21, and Day 63
Vomiting severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 vomiting grading scale. Severity was graded from 0 to 4, with 0 indicating no vomiting and higher grades indicating greater symptom severity; grade 4 indicates life-threatening severity.
Baseline before treatment and education, Day 21, and Day 63
Diarrhea Severity Assessed by NCI-CTC Version 2.0
Prazo: Baseline before treatment and education, Day 21, and Day 63
Diarrhea severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 diarrhea grading scale. Severity was graded from 0 to 4, with 0 indicating no diarrhea and higher grades indicating greater symptom severity.
Baseline before treatment and education, Day 21, and Day 63
Constipation Severity Assessed by NCI-CTC Version 2.0
Prazo: Baseline before treatment and education, Day 21, and Day 63
Constipation severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 constipation grading scale. Severity was graded from 0 to 4, with 0 indicating no constipation and higher grades indicating greater symptom severity; grade 4 indicates obstruction or toxic megacolon.
Baseline before treatment and education, Day 21, and Day 63
Fatigue Severity Assessed by NCI-CTC Version 2.0
Prazo: Baseline before treatment and education, Day 21, and Day 63
Fatigue severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 fatigue grading scale. Severity was graded from 0 to 4, with 0 indicating no fatigue and higher grades indicating greater symptom severity.
Baseline before treatment and education, Day 21, and Day 63
Dyspnea Severity Assessed by NCI-CTC Version 2.0
Prazo: Baseline before treatment and education, Day 21, and Day 63
Dyspnea severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 dyspnea grading scale. Severity was graded from 0 to 4, with 0 indicating no dyspnea and higher grades indicating greater symptom severity; grade 4 indicates dyspnea at rest or a need for ventilatory support.
Baseline before treatment and education, Day 21, and Day 63

Colaboradores e Investigadores

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

Patrocinador

Can Lafci

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)

5 de fevereiro de 2018

Conclusão Primária (Real)

31 de agosto de 2018

Conclusão do estudo (Real)

31 de agosto de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

15 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de agosto de 2026

Primeira postagem (Real)

19 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • EGE-MASTER_CL_35

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data are not planned to be shared.

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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