Stem Cell Transplantation, HematopoieticHSCT-EPNCT07781046
Hematopoietic Stem Cell Transplantation Empowerment Program
A study testing Empowerment program in people with Stem Cell Transplantation, Hematopoietic, run by Mansoura University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Stem Cell Transplantation, Hematopoietic
- What is being tested?
- Empowerment program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with physical or mental limitations.
- Patients involved in other programs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the 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
- Conditions
- Stem Cell Transplantation, Hematopoietic
- Being tested
- Empowerment program
- Keywords
- Stem Cell Transplantation, Hematopoietic, Empowerment program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment programBehavioural
A structured nursing-led empowerment program designed to improve patients' knowledge, self-care skills, and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Control and study groups | Experimental | 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. Receives: Behavioral: Empowerment program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's demographic and health-relevant Data
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.
Measured: Baseline (pre-intervention)
Secondary outcomes (1)
Patient's Knowledge Assessment Questionnaire
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.
Measured: Baseline, immediately post-intervention, and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Jan 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplantation, HematopoieticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a quasi-experimental, two-group pretest-posttest design
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ola ebrahim elsherbiny, Mansoura University
- Investigators
- Ola Ebrahim Elsherbiny, Assistant professor, Principal investigator, Faculty of Nursing, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781046
- Sponsor's protocol ID
- IRP.437
- Acronym
- HSCT-EP
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Empowerment Program for Patients Undergoing Stem Cell Transplantation on Their Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07781046
- Acronym / sponsor ID
- HSCT-EP / IRP.437
- Conditions
- Stem Cell Transplantation, Hematopoietic
- Keywords
- Stem Cell Transplantation, Hematopoietic, Empowerment program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a quasi-experimental, two-group pretest-posttest design
| Arm | Type | Receives |
|---|---|---|
| Control and study groups | Experimental | Behavioral: Empowerment programThe 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with physical or mental limitations.
- Patients involved in other programs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowerment programA structured nursing-led empowerment program designed to improve patients' knowledge, self-care skills, and quality of life. | Behavioural | Control and study groups |
Primary outcome
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.
1 secondary outcome
Patient's Knowledge Assessment Questionnaire
Time frame: Baseline, immediately post-intervention, and 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ola Ebrahim Elsherbiny, Assistant professor principal investigator
Faculty of Nursing, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment program in people with Stem Cell Transplantation, Hematopoietic, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's demographic and health-relevant Data (time frame: Baseline (pre-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.