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
Completed
Conditions
Intervention / Treatment
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:
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.
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.
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).
- 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
Interventional
Enrollment (Actual)
30
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Investigators
- 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)
January 1, 2025
Primary Completion (Actual)
February 1, 2026
Study Completion (Actual)
February 1, 2026
Study Registration Dates
First Submitted
August 17, 2026
First Submitted That Met QC Criteria
August 20, 2026
First Posted (Actual)
August 24, 2026
Study Record Updates
Last Update Posted (Actual)
August 24, 2026
Last Update Submitted That Met QC Criteria
August 20, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Other Study ID 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
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