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Hematopoietic Stem Cell Transplantation Empowerment Program (HSCT-EP)

20 de agosto de 2026 atualizado por: ola ebrahim elsherbiny, Mansoura University

The Impact of an Empowerment Program for Patients Undergoing Stem Cell Transplantation on Their Clinical Outcomes

The goal of this study is to evaluate the impact of an empowerment program for patients undergoing stem cell transplantation on their clinical outcomes.

The research hypothesis are:

  • Patients who participate in the proposed empowerment program will exhibit a significant improvement in their knowledge related to stem cell transplantation than those who don't.
  • Patients who participate in the proposed empowerment program will exhibit a significant improvement in their self-care practices than those who don't.
  • Patients who participate in the proposed empowerment program will exhibit a significant improvement in their health-related quality of life than those who don't.

The study sample was divided into control and study groups. Study group (A) who was received routine care in addition to empowerment program, while control group (B) who was received routine care only.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

Research design: Quasi-experimental pre\post research design using control group will be utilized.

This study will be conducted in stem cell transplantation unite at Oncology Center affiliated to Mansoura University Hospitals.

A purposive sample will be recruited from the previously mentioned setting according to the following criteria:

  • Conscious, adult patients at the age of 20-60 years from both genders.
  • Able to communicate verbally and exhibited a willingness to participate in the

The study sample will be randomly divided into two equal groups as follow:

  • The control group who will receive standard hospital care only.
  • The study group who will receive standard hospital care in addition to an empowerment program that includes education, counseling, and support.

Data collection process:

Phase I: Preparatory phase:

  • An Ethical approval will be obtained from the Research Scientific Ethical Committee of the Faculty of Nursing, Mansoura University.
  • An official written permission to carry out the study will be obtained from the responsible authorities of the oncology center in Mansoura University Hospital, to obtain his approval to conduct the study after an explanation of the purpose of the study.
  • The researcher will meet the health care providers including nursing staff of the stem cell transplantation unit to coordinate the study process that will be conducted among patients.

Phase II: The operational phase/ Filed work:

The framework of the study will be carried out in four stages as the following:

  1. Assessment phase:

    • Once the necessary permission will be granted to proceed with the proposed study, the patients who will undergo SCT and who met the sampling criteria and agreed to participate in the study will be interviewed at SCT unit of the oncology center by the researcher to collect the necessary data pertinent to the study.
    • Pretest assessment will be performed at the beginning of the study and consider as base line data for latter comparison with future posttest. Each patient of both control and study groups will be interviewed individually by researcher in the 1st week before applying the planned empowerment program to collect the baseline data using all the study tools.
    • Data collection will be started by assessing demographic data, health-relevant data, through interviewing with each patient using the tool I.
    • The researcher will assess the patient's Knowledge using the tool II to assess the educational needs of each patient to consider it when preparing the empowerment program.
    • The researcher will assess the patient's self-practice using the tool III. Every patient will be observed to collect data of observational check list during the morning and afternoon shift.
  2. Planning phase:

    - Based on the findings of the assessment phase, the researcher will design the proposed empowerment program in a simple Arabic language after reviewing recent relevant literatures.

  3. Implementation phase:

    • The study sample will be divided into control and study groups. Study group (A) who will receive routine care in addition to empowerment program, while control group (B) who will receive routine care only.
    • In study group (A) the empowerment program for patients undergoing SCT will be implemented in a slow speed, regular rhythm and depths:
    • The empowerment program sessions will take 30-45 minutes on the average.
    • Each patient will have 3-4 sessions of the empowerment program in pre-transplant period.
    • The content of the program will included an educational and a training component. The educational part will consisted of stem cell transplantation procedure, advantages and risks, preparatory instructions for SCT, symptoms management, complications of SCT, and post -SCT follow up instructions. Practical or training part will include (hand and oral hygiene, early ambulation, etc).
  4. Evaluation phase:

The final step of data collection is evaluating the patient's response to the proposed program and the extent to which the outcomes have been achieved.

  • Posttest assessment will carry out after implementation of the empowerment program to identify its impact on patient's knowledge and clinical outcomes by use tool II, III & tool IV for both groups.
  • Follow up assessment will carry out after three months to identify the impact of the empowerment program on patient's knowledge and clinical outcomes using the study tools.

Ethical consideration: All relevant possible aspects will be considered. Written consent will be obtained from each patient enrolled in the study after providing comprehensive information about the nature of the study, aim, benefits and risks. The researcher will emphasize that participation is absolutely voluntary. Participants will be informed that they have the right to refuse to participate in the study and withdrawn at any time and the refusal to participate in the study will not affect their care. Anonymity, privacy, safety, and confidentiality will be assure

Tipo de estudo

Intervencional

Inscrição (Real)

30

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

    • Dakhlia
      • Al Mansurah, Dakhlia, Egito, 35516
        • Faculty of nursing

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

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Conscious, adult patients at the age of 20-60 years from both genders.
  • Able to communicate verbally and exhibited a willingness to participate in the study.

Exclusion criteria:

  • Patients with physical or mental limitations.
  • Patients involved in other programs.

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: Control and study groups
The study sample was divided into control and study groups. Study group (A) who was received routine care in addition to empowerment program, while control group (B) who was received routine care only.
A structured nursing-led empowerment program designed to improve patients' knowledge, self-care skills, and quality of life.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Patient's demographic and health-relevant Data
Prazo: Baseline (pre-intervention)
A structured interview questionnaire developed by the researcher will be used to collect patients' demographic and health-relevant characteristics. Demographic data will include age, sex, occupation, marital status, and educational level. Health-relevant data will include diagnosis, current and previous medical history, genetic diseases, source and type of stem cell transplantation, and family history of previous stem cell transplantation.
Baseline (pre-intervention)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Patient's Knowledge Assessment Questionnaire
Prazo: Baseline, immediately post-intervention, and 3 months post-intervention
A researcher-developed Patient's Knowledge Assessment Questionnaire will be used to assess patients' knowledge regarding stem cell transplantation. The questionnaire will be developed based on recent and relevant literature and will cover the stem cell transplantation procedure, benefits and risks, pre-transplant preparatory instructions, symptom management, potential complications, and post-transplant care instructions. Each item will be scored as 1 for a correct answer and 0 for an incorrect answer or "don't know" response. Higher scores indicate greater knowledge.
Baseline, immediately post-intervention, and 3 months post-intervention

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Patient's Self-Care Practices Observational Checklist
Prazo: Baseline, immediately post-intervention, and 3 months post-intervention
A researcher-developed observational checklist will be used to assess patients' self-care practices during the stem cell transplantation process. The checklist consists of five domains with a total of 81 observational items. The researcher will assess patients' self-care practices through direct observation. Each item will be scored as 1 for "done" and 0 for "not done." Higher scores indicate better self-care practices.
Baseline, immediately post-intervention, and 3 months post-intervention

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Ola Ebrahim Elsherbiny, Assistant professor, Faculty of Nursing, Mansoura 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 janeiro de 2025

Conclusão Primária (Real)

1 de fevereiro de 2026

Conclusão do estudo (Real)

1 de fevereiro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

17 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de agosto de 2026

Primeira postagem (Real)

24 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • IRP.437

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared with other researchers because the study involves confidential participant health information and will be maintained in accordance with ethical and institutional requirements.

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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