Stem Cell TransplantationHEMATOneedsNCT06506396
Rehabilitation Needs for Hematologic Cancer Candidate for Hematopoietic Stem Cell Transplantation or CAR T-Cell Therapy
An observational study of Stem Cell Transplantation and Immunotherapy, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
Hematopoietic Stem Cell Transplantation (HSCT) and CAR T-cell therapy are effective treatments for blood cancers, extending patients lives. However, these treatments can cause side effects like muscle weakness and fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stem Cell Transplantation, Immunotherapy, CAR T-Cell Therapy
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2024to May 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The potential participants will be selected at the Hematology Unit of the Azienda USL-IRCCS di Reggio Emilia among patients undergoing hematopoietic stem cell transplantation or CAR T-cell treatment, identified two months prior to their treatment.
Who may be able to join
- Patients with hematologic cancer scheduled to undergo HSCT or CAR T-cell therapy;
- Age ≥18 years
- Able to provide informed consent to participate in the study
- Able to understand and participate in the study
- Able to understand and communicate in the Italian language
Who cannot join
- Patients who are unable to perform physical tests or have contraindications to movement
Trial locations and contacts
1 site in 1 country.
Italy1 site
AUSL-IRCCS di Reggio Emilia
Reggio Emilia, 42122
Margherita Schiavi, Phd Candidate, +390522522 ext. 441, margherita.schiavi@ausl.re.it
Stefania Costi, PhD, Researcher, +390522522441 ext. 441, stefania.costi@unimore.it
About this study
Official title: Outcomes and Rehabilitation Needs of Patients With Hematologic Cancer Candidate for Hematopoietic Stem Cell Transplantation or CAR T-Cell Therapy: a Prospective Observational Study
Hematopoietic Stem Cell Transplantation (HSCT) and CAR T-cell therapy are effective treatments for blood cancers, extending patients lives. However, these treatments can cause side effects like muscle weakness and fatigue. Recent findings suggest these issues can significantly affect patient quality of life during CAR T-cell therapy.
Patients undergoing HSCT and CAR T-cell therapy often face frequent infections and strong immune responses, requiring long periods of rest. This worsens their physical condition and impacts their quality of life, muscle strength, and fatigue levels. Minimizing these side effects is crucial to improve the well-being of patients undergoing these advanced treatments.
This study aims to assess the physical abilities (main goal) of patients preparing for HSCT or CAR T-cell therapy. It also aims to examine their quality of life and describe the symptoms and complications they may experience. The results will help identify rehabilitation needs for these patients.
Read the detailed description
This is a prospective observational study following STROBE guidelines for observational studies in epidemiology. The study will take place at the Azienda USL-IRCCS di Reggio Emilia, Northern Italy.
Participants will include adults with blood cancer scheduled for HSCT or CAR T-cell therapy. They must be able to understand and speak Italian and make an informed decision to participate in the study.
Patients will be identified at the Hematology Unit of Azienda USL-IRCCS di Reggio Emilia. Medical records will be reviewed to confirm eligibility. Eligible patients will receive detailed information about the study and can decide to participate by signing a consent form.
The study will last 24 months, with an 8-month enrollment period and an 8-month follow-up. Approximately 20 participants will be enrolled based on the number of patients who received HSCT and CAR T-cell therapy in 2023.
Data on participants Sociodemographic and clinical characteristics will be collected at the start of the study. Complications and hospitalizations will be monitored after treatments to understand their impact on patients health.
This study aims to provide valuable insights into the rehabilitation needs of patients undergoing HSCT and CAR T-cell therapy.
- Conditions
- Stem Cell Transplantation, Immunotherapy, CAR T-Cell Therapy
- Keywords
- Functional Status, Quality of life, Needs Assesment, Physical Conditioning, Human, Hematologic Neoplasms
- Medical subject headings
- Motor Activity, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hematologic cancer scheduled to undergo HSCT or CAR T-cell therapy | The participants will be selected at the Hematology Unit of Azienda USL-IRCCS di Reggio Emilia, Northern Italy, two months prior to undergoing transplantation or CAR-T cell treatment. Eligible participants must meet the following inclusion criteria: have hematologic cancer and be scheduled for HSCT or CAR T-cell therapy; be at least 18 years old; able to provide informed consent and actively participate in the study; proficient in understanding and communicating in Italian. Patients who are unable to perform physical tests or have contraindications to movement will be excluded from the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
Time up and go (TUG)
Measured: From enrollment up to 8 months later.
Phyical Function
Short Physical Performance Battery (SPPB)
Measured: From enrollment up to 8 months later.
Secondary outcomes (7)
Strength
Handgrip strength test
Measured: From enrollment up to 8 months later.
Quality of life
European Organization for Research and Treatment of Cancer QoL Questionnaire-C30 -QLQ C30. This questionnaire will be administered to assess participants' quality of life. It comprises one global scale, five functional scales, three symptom scales, and six single item scale.All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems
Measured: From enrollment up to 8 months later.
Fatigue
Functional Assesment of Chronic IIlness Therapy-Fatigue.the total score range is 0 to 52. The general population mean score is 43. Lower scores indicate greater fatigue.
Measured: From enrollment up to 8 months later.
Activity of daily living
Duke Activities Score Index (DASI).The DASI is a 12-item questionnaire that asses daily activities in the following domain: productivity, self-care, and leisure time. Total score ranges from 0 to 58.2. Higher scores indicate higher self-perceived functional ability.
Measured: From enrollment up to 8 months later.
Physical activity
International Physical Activities Questionnarie_Short Form (IPAQ-SF).This self-reported questionnaire provides information on the intensity, duration, and frequency of various physical activities, offering valuable insights into participants' overall activity levels. In addition, Metabolic Equivalent of Tasks (METs) are used to classifies the level of patients' physical activity as low (<600 MET), moderate (from 600 to 3000 MET), or high (≥ 3000 MET)
Measured: From enrollment up to 8 months later.
KInesiophobia
Tampa Scale of Kinesiophobia (TSK)The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia
Measured: From enrollment up to 8 months later.
Walking ability
Functional Ambulation Category (FAC).Clinician-completed tick box of 5 broad categories of walking ability, ranges from independent walking outside (score 5) to non-functional walking (score 0).
Measured: From enrollment up to 8 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell TransplantationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS
- Responsible party
- Principal investigator, Stefania Costi, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506396
- Sponsor's protocol ID
- 2024/0087161_26/06/2024
- Acronym
- HEMATOneeds
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are sensible data and then will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Rehabilitation Needs of Patients With Hematologic Cancer Candidate for Hematopoietic Stem Cell Transplantation or CAR T-Cell Therapy: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06506396
- Acronym / sponsor ID
- HEMATOneeds / 2024/0087161_26/06/2024
- Conditions
- Stem Cell Transplantation, Immunotherapy, CAR T-Cell Therapy
- Keywords
- Functional Status, Quality of life, Needs Assesment, Physical Conditioning, Human, Hematologic Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS
- Study start
- Aug 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 17 Jul 2024 (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.
Hematopoietic Stem Cell Transplantation (HSCT) and CAR T-cell therapy are effective treatments for blood cancers, extending patients lives. However, these treatments can cause side effects like muscle weakness and fatigue. Recent findings suggest these issues can significantly affect patient quality of life during CAR T-cell therapy.
Patients undergoing HSCT and CAR T-cell therapy often face frequent infections and strong immune responses, requiring long periods of rest. This worsens their physical condition and impacts their quality of life, muscle strength, and fatigue levels. Minimizing these side effects is crucial to improve the well-being of patients undergoing these advanced treatments.
This study aims to assess the physical abilities (main goal) of patients preparing for HSCT or CAR T-cell therapy. It also aims to examine their quality of life and describe the symptoms and complications they may experience. The results will help identify rehabilitation needs for these patients.
Detailed description
This is a prospective observational study following STROBE guidelines for observational studies in epidemiology. The study will take place at the Azienda USL-IRCCS di Reggio Emilia, Northern Italy.
Participants will include adults with blood cancer scheduled for HSCT or CAR T-cell therapy. They must be able to understand and speak Italian and make an informed decision to participate in the study.
Patients will be identified at the Hematology Unit of Azienda USL-IRCCS di Reggio Emilia. Medical records will be reviewed to confirm eligibility. Eligible patients will receive detailed information about the study and can decide to participate by signing a consent form.
The study will last 24 months, with an 8-month enrollment period and an 8-month follow-up. Approximately 20 participants will be enrolled based on the number of patients who received HSCT and CAR T-cell therapy in 2023.
Data on participants Sociodemographic and clinical characteristics will be collected at the start of the study. Complications and hospitalizations will be monitored after treatments to understand their impact on patients health.
This study aims to provide valuable insights into the rehabilitation needs of patients undergoing HSCT and CAR T-cell therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hematologic cancer scheduled to undergo HSCT or CAR T-cell therapy | – | –The participants will be selected at the Hematology Unit of Azienda USL-IRCCS di Reggio Emilia, Northern Italy, two months prior to undergoing transplantation or CAR-T cell treatment. Eligible participants must meet the following inclusion criteria: have hematologic cancer and be scheduled for HSCT or CAR T-cell therapy; be at least 18 years old; able to provide informed consent and actively participate in the study; proficient in understanding and communicating in Italian. Patients who are unable to perform physical tests or have contraindications to movement will be excluded from the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The potential participants will be selected at the Hematology Unit of the Azienda USL-IRCCS di Reggio Emilia among patients undergoing hematopoietic stem cell transplantation or CAR T-cell treatment, identified two months prior to their treatment.
Key inclusion criteria (5 listed)
- Patients with hematologic cancer scheduled to undergo HSCT or CAR T-cell therapy;
- Age ≥18 years
- Able to provide informed consent to participate in the study
- Able to understand and participate in the study
- Able to understand and communicate in the Italian language
Key exclusion criteria (1 listed)
- Patients who are unable to perform physical tests or have contraindications to movement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical function
Time frame: From enrollment up to 8 months later.
Time up and go (TUG)
Phyical Function
Time frame: From enrollment up to 8 months later.
Short Physical Performance Battery (SPPB)
7 secondary outcomes
Strength
Time frame: From enrollment up to 8 months later.
Quality of life
Time frame: From enrollment up to 8 months later.
Fatigue
Time frame: From enrollment up to 8 months later.
Activity of daily living
Time frame: From enrollment up to 8 months later.
Physical activity
Time frame: From enrollment up to 8 months later.
KInesiophobia
Time frame: From enrollment up to 8 months later.
Walking ability
Time frame: From enrollment up to 8 months later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: No. IPD are sensible data and then will not be shared
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Transplantation and Immunotherapy, run by University of Modena and Reggio Emilia at 1 site in Italy.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Jul 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margherita Schiavi, PhD Candidate (+390522522441, margherita.schiavi@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function (time frame: From enrollment up to 8 months later.). The study lists 2 primary outcomes in all. 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 19 Jul 2024.