Hematopoietic Stem Cell Transplantation Empowerment Program (HSCT-EP)

August 20, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Empowerment program
A structured nursing-led empowerment program designed to improve patients' knowledge, self-care skills, and quality of life.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient's demographic and health-relevant Data
Time Frame: 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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient's Knowledge Assessment Questionnaire
Time Frame: 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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient's Self-Care Practices Observational Checklist
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ola Ebrahim Elsherbiny, Assistant professor, Faculty of Nursing, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRP.437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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