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Hematopoietic Stem Cell Transplantation Empowerment Program (HSCT-EP)

2026년 8월 20일 업데이트: 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.

연구 개요

상태

완전한

상세 설명

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

연구 유형

중재적

등록 (실제)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Patient's demographic and health-relevant Data
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Patient's Knowledge Assessment Questionnaire
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Patient's Self-Care Practices Observational Checklist
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Ola Ebrahim Elsherbiny, Assistant professor, Faculty of Nursing, Mansoura University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 1월 1일

기본 완료 (실제)

2026년 2월 1일

연구 완료 (실제)

2026년 2월 1일

연구 등록 날짜

최초 제출

2026년 8월 17일

QC 기준을 충족하는 최초 제출

2026년 8월 20일

처음 게시됨 (실제)

2026년 8월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 20일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • IRP.437

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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