Hematological MalignancyNCT07066592
Investigation of the Effects of Prehabilitation Education Delivered Through a Mobile Compatible Website on Quality of Life and Symptoms in Patients Undergoing Hematopoietic Stem Cell Transplantation
A study testing Prehabilitation education provided via mobile compatible website in people with Hematological Malignancy and Prehabilitation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Aim of the Study: The aim of this study is to examine the effect of prehabilitation education delivered via a mobile-compatible website on the quality of life and symptom evaluation of patients undergoing hematopoietic stem cell transplantation (HSCT). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hematological Malignancy, Prehabilitation, Patient Education
- What is being tested?
- Prehabilitation education provided via mobile compatible website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Dec 2024to 15 Aug 2025
- Phase
- Interventional
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing Hematopoietic Stem Cell Transplantation (HSCT) for the first time
- Having no musculoskeletal problems that would prevent physical activity
- Volunteering to participate in the study
- Between 18 and 70 years of age
- Having access to and the ability to use a mobile phone and the internet
- Literate in Turkish (able to read and write in Turkish)
Who cannot join
- Having a condition that prevents effective communication
- Being illiterate (unable to read and write)
- Inability to use technology
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Oncology Training and Research Hospital
Ankara
About this study
Aim of the Study:
The aim of this study is to examine the effect of prehabilitation education delivered via a mobile-compatible website on the quality of life and symptom evaluation of patients undergoing hematopoietic stem cell transplantation (HSCT).
Read more
Research Questions:
What is the effect of prehabilitation education delivered via a mobile-compatible website on the quality of life of stem cell transplant patients? What is the effect of prehabilitation education delivered via a mobile-compatible website on the symptom management of stem cell transplant patients?
Method:
In this study, patients will be randomly assigned to one of two groups:
One group will receive prehabilitation education through a mobile-compatible website.
The other group will receive standard educational procedures.
Read the detailed description
Hematopoietic Stem Cell Transplantation (HSCT) is an intensive treatment with the potential to cure hematologic malignancies and other highly morbid diseases. However, it is also associated with significant risks of morbidity and mortality. Many HSCT patients experience a variety of physical, emotional, and cognitive symptoms, particularly during the acute recovery phase following transplantation. Gastrointestinal symptoms such as nausea, vomiting, loss of appetite, mucositis, and changes in taste often emerge during the pre-transplant conditioning period and may persist for an extended period after the transplant.
Loss of strength and pain are among the most common and severe symptoms during the acute recovery phase. Other frequently encountered symptoms include anorexia, loss of muscle mass, and fatigue. During hospitalization, HSCT patients may also experience clinically significant emotional symptoms such as anxiety, depression, or adjustment disorders. These symptoms can negatively impact patients' subjective symptom burden, treatment adherence, and length of hospital stay.
Therefore, accurate assessment and management of symptoms and risks during hospitalization are essential to minimize the symptom burden in HSCT patients. Since HSCT involves high-dose chemotherapy, prolonged hospital stays, and strict isolation protocols, transplant-specific quality of life (QoL) assessment is crucial. Evaluating QoL in transplant patients can help healthcare professionals understand patients' physical, psychological, and social well-being and identify their rehabilitation needs.
Numerous symptoms caused by the disease and HSCT, as well as transplant-specific complications, significantly reduce patients' quality of life and adversely affect long-term transplant outcomes. For this reason, it is important to prepare patients adequately before undergoing HSCT. In such cases, the concept of prehabilitation is considered essential. Prehabilitation is a clinical model that introduces rehabilitation components to patients before intensive medical interventions, aiming to optimize functionality and improve tolerance to treatment.
Cancer prehabilitation is a part of the cancer rehabilitation care process. It occurs between the time of cancer diagnosis and the start of acute treatment. It includes physical and psychological assessments to establish a baseline functional level, identify impairments, and provide interventions that promote psychological health and physical improvement to reduce the incidence and/or severity of future impairments.
The aim of this study is to investigate the effect of prehabilitation education provided via a mobile-compatible website on the quality of life and symptom evaluation of patients undergoing HSCT. Patients will be randomly assigned to two groups: one group will receive prehabilitation education via a mobile-compatible website, while the other group will receive standard education procedures.
Both groups will be assessed using the Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) and the Edmonton Symptom Assessment Scale (ESAS) on the day of hospital admission, the day of transplantation, and the day of discharge.
The web-based educational content consists of 9 sections:
What is stem cell transplantation? Pre-transplant preparation period Stem cell transplantation procedure and engraftment What is oral mucositis (mouth sores)? How to perform oral care? What is the risk of infection? How to protect yourself from infection? Side effects of transplant treatment Nutrition and food preparation after transplantation Returning home after stem cell transplantation and home exercise suggestions before transplant At the end of the study, the test results of the patient groups will be compared both within and between groups. The study aims to determine whether the group receiving prehabilitation education through a mobile-compatible website differs significantly from the group receiving standard education and to evaluate the impact of the educational intervention on patient outcomes.
- Conditions
- Hematological Malignancy, Prehabilitation, Patient Education
- Being tested
- Prehabilitation education provided via mobile compatible website
- Keywords
- prehabilitation, quality of life, bone marrow transplantation, education
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation education provided via mobile compatible websiteBehavioural
The prehabilitation education delivered through a mobile-compatible website was developed specifically for patients who are candidates for stem cell transplantation. Through this platform, patients can easily and quickly access accurate information on managing potential symptoms during the transplant process, as well as guidance on nutrition and exercise aimed at improving their quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation education provided via mobile compatible website | Experimental | Participants will receive access to the educational website containing information on the stem cell transplantation process, consisting of 9 sections, one week prior to hospital admission. Receives: Behavioral: Prehabilitation education provided via mobile compatible website |
| Control | No intervention | Participants will receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom management
Edmonton Symptom Assessment Scale. Each symptom is evaluated using numerical ratings ranging from 0 to 10. A score of 0 indicates that the symptom is absent, while a score of 10 indicates that the symptom is felt very severely. The severity of the symptom increases progressively from 0 to 10. (The changes will be evaluated from the baseline level to the day of transplantation and up to the day of discharge. This period takes approximately 3-4 weeks on average)
Measured: The baseline and average 3-4 weeks
quality of functionality
Functional Assessment of Cancer Therapy-Bone Marrow Transplant (4th version) The minimum score obtainable from the FACT-BMT scale is 0, and the maximum score is 148. Higher scores indicate a better quality of life. (The changes will be evaluated from the baseline level to the day of transplantation and up to the day of discharge. This period takes approximately 3-4 weeks on average)
Measured: The baseline and average 3-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start13 Dec 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hematological MalignancyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Oncology Research and Training Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066592
- Sponsor's protocol ID
- 2024-11/74
- Status last verified
- Dec 2024
- First submitted
- 25 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Normann AJ, Mo CC, Wilson RL, Perez M, Cutler C, Uno H, Thompson LV, Skinner TL, Richardson PG, Marinac CR, Dieli-Conwright CM. Prehabilitation Exercise Training to Target Improved Muscle Strength in Pretransplant Patients Diagnosed With Multiple Myeloma: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 19;13:e64905. doi: 10.2196/64905.
PubMed 39701583Naumann K, Singh B, Bushaway S, Crane R, Deepak S, Hartland A, Konstantopoulos P, Mansell E, Marinelli V, Pallotta V, Tolfts A, Virieux A, Wall M, Wilksch S, Zhuang M, Atkinson M, Maher C. Investigating the impact of multidisciplinary prehabilitation on deconditioning in patients eligible for haematopoietic allogenic stem cell transplantation: protocol for a feasibility trial. BMJ Open. 2024 Sep 5;14(9):e084372. doi: 10.1136/bmjopen-2024-084372.
PubMed 39237275Dennett AM, Porter J, Ting SB, Taylor NF. Prehabilitation to improve function after autologous stem cell transplantation: A pilot randomized controlled trial (PIRATE). Support Care Cancer. 2025 Feb 7;33(3):164. doi: 10.1007/s00520-025-09179-1.
PubMed 39920425