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Hematopoietic Stem Cell Transplantation Empowerment Program (HSCT-EP)

20. august 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient's demographic and health-relevant Data
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient's Knowledge Assessment Questionnaire
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient's Self-Care Practices Observational Checklist
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2025

Primær fullføring (Faktiske)

1. februar 2026

Studiet fullført (Faktiske)

1. februar 2026

Datoer for studieregistrering

Først innsendt

17. august 2026

Først innsendt som oppfylte QC-kriteriene

20. august 2026

Først lagt ut (Faktiske)

24. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • IRP.437

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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