Quality of LifeQOL-ONE PRO-CTNCT07289087
Patient-Reported Outcomes in Allogeneic Stem Cell Transplantation and CAR-T Therapy
An observational study of Quality of Life and Patient Reported Outcome (PRO), run by Associazione Qol-one.
Trial summary
3.1. Overview Prospective, multicenter, observational cohort study comparing short-term PROs measured with the HM-PRO between two exposure groups: patients undergoing allogeneic stem cell transplantation (allo-SCT) and patients receiving CAR-T cell therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Patient Reported Outcome (PRO), Allogeneic Blood and Marrow Transplantation (BMT)
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults (≥18 years) with a hematologic malignancy admitted for either (a) allo-SCT or (b) CAR-T cell therapy.
Who may be able to join
- Diagnosed with a hematologic malignancy (e.g., leukemia, lymphoma, multiple myeloma)
- Undergoing either allogeneic SCT or CAR-T therapy
- Able and willing to provide written informed consent
- Sufficient Italian proficiency to complete the HM-PRO
- Signed informed consent
Who cannot join
- Cognitive or physical impairments that preclude the ability to complete questionnaires
- Estimated life expectancy < 7 days at the time of admission
About this study
Official title: A Real-World Observational Study on Patient-Reported Outcomes in Allogeneic Stem Cell Transplantation (Allo-SCT) and CAR-T Therapy
3.1. Overview Prospective, multicenter, observational cohort study comparing short-term PROs measured with the HM-PRO between two exposure groups: patients undergoing allogeneic stem cell transplantation (allo-SCT) and patients receiving CAR-T cell therapy. Patients will be enrolled at hospital admission for the index inpatient procedure and followed through the inpatient stay (admission → discharge). The study is non-randomized and designed to describe trajectories of symptoms and HRQoL and to estimate the between-group difference in deterioration of HM-PRO scores (primary estimand: mean difference in change score, CAR-T vs allo-SCT).
- Conditions
- Quality of Life, Patient Reported Outcome (PRO), Allogeneic Blood and Marrow Transplantation (BMT), CAR T Cell Therapy
- Keywords
- Quality of Life, CAR-T cell therapy, Allogenic BMT, Patient Reported Outcome, Leukemia, Multiple Myeloma, Lymphoma
- Medical subject headings
- Leukemia, Multiple Myeloma, Lymphoma
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 |
|---|---|---|
| CAR-T | Not described | |
| ALLO-SCT | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess and compare short-term patient-reported outcomes [PROs (symptom burden and QoL impact)] between patients receiving allo-SCT and CAR-T therapy using the HM-PRO questionnaire (Impact Scale, Symptoms Scale) from admission to hospital discharge
The primary outcome aims to evaluate the impact of CAR-T therapy and allogeneic transplantation on patients' quality of life using a specific questionnaire (HM-PRO), which assesses PROs (quality of life and symptoms) in hematologic patients, with the goal of determining whether there are differences between the two patient groups.
In the HM-PRO questionnaire values range from 0 to 100. Lower values correspond to a better quality of life and a lower symptom burden.
Measured: 3 MONTHS
Secondary outcomes (5)
To describe PRO trajectories during hospitalization
Patient-reported outcomes will be assessed using the Hematological Malignancy Patient-Reported Outcome (HM-PRO) instrument, which includes an Impact Scale and a Symptoms Scale. HM-PRO assessments will be performed at five predefined time points during hospitalization: T1 (hospital admission), T2 (day of infusion), T3 (day 3 post-infusion), T4 (day 10 post-infusion), and T5 (day of discharge). The secondary outcome will describe within-patient trajectories of HM-PRO scores over these time points. Data will be summarized using mean scores and mean changes from baseline (T1) for total and domain scores, to characterize changes in symptom burden and QoL impact throughout hospitalization.
Measured: 3 MONTHS
To assess differences in PROs based on disease type (e.g., Leukemia, lymphoma, myeloma)
Since patients with different hematologic diseases are involved, the quality-of-life and symptom outcomes may vary for each condition.
Measured: 3 MONTHS
To assess differences in PROs based on disease status (remission vs progression)
Patients at enrollment may be in remission or in disease progression. the quality-of-life and symptom outcomes may vary for each condition.
Measured: 3 MONTHS
To assess differences in PROs based on treatment line (first-line vs multiple lines)
At enrollment, patients may have received first vs multiple lines of treatment. the quality-of-life and symptom outcomes may vary for each condition.
Measured: 3 MONTHS
To validate the use of the HM-PRO in the context of inpatient care for advanced therapies.
This outcome will evaluate the psychometric properties of the Hematological Malignancy Patient-Reported Outcome (HM-PRO) questionnaire in the inpatient setting of advanced cellular therapies (allo-SCT and CAR-T). HM-PRO assessments are collected at five time points during hospitalization-T1 (admission), T2 (day of infusion), T3 (day 3 post-infusion), T4 (day 10 post-infusion), and T5 (discharge). Psychometric analyses will assess:
Internal consistency reliability of the Impact and Symptoms Scales (Cronbach's alpha).
Construct validity, evaluated through known-groups comparisons (allo-SCT vs CAR-T; remission vs progression).
Responsiveness to clinical change, assessed by changes in HM-PRO scores over time in relation to clinical status and adverse events.
These analyses will determine whether HM-PRO performs adequately for use in routine inpatient clinical practice for advanced therapies.
Measured: 3 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start15 Feb 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associazione Qol-one
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289087
- Sponsor's protocol ID
- QOL-ONE PRO-CT
- Acronym
- QOL-ONE PRO-CT
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Observational Study on Patient-Reported Outcomes in Allogeneic Stem Cell Transplantation (Allo-SCT) and CAR-T Therapy
- ClinicalTrials.gov ID
- NCT07289087
- Acronym / sponsor ID
- QOL-ONE PRO-CT / QOL-ONE PRO-CT
- Conditions
- Quality of Life, Patient Reported Outcome (PRO), Allogeneic Blood and Marrow Transplantation (BMT), CAR T Cell Therapy
- Keywords
- Quality of Life, CAR-T cell therapy, Allogenic BMT, Patient Reported Outcome, Leukemia, Multiple Myeloma, Lymphoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Associazione Qol-oneUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 17 Dec 2025 (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.
3.1. Overview Prospective, multicenter, observational cohort study comparing short-term PROs measured with the HM-PRO between two exposure groups: patients undergoing allogeneic stem cell transplantation (allo-SCT) and patients receiving CAR-T cell therapy. Patients will be enrolled at hospital admission for the index inpatient procedure and followed through the inpatient stay (admission → discharge). The study is non-randomized and designed to describe trajectories of symptoms and HRQoL and to estimate the between-group difference in deterioration of HM-PRO scores (primary estimand: mean difference in change score, CAR-T vs allo-SCT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAR-T | – | – |
| ALLO-SCT | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years) with a hematologic malignancy admitted for either (a) allo-SCT or (b) CAR-T cell therapy.
Key inclusion criteria (5 listed)
- Diagnosed with a hematologic malignancy (e.g., leukemia, lymphoma, multiple myeloma)
- Undergoing either allogeneic SCT or CAR-T therapy
- Able and willing to provide written informed consent
- Sufficient Italian proficiency to complete the HM-PRO
- Signed informed consent
Key exclusion criteria (2 listed)
- Cognitive or physical impairments that preclude the ability to complete questionnaires
- Estimated life expectancy < 7 days at the time of admission
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
To assess and compare short-term patient-reported outcomes [PROs (symptom burden and QoL impact)] between patients receiving allo-SCT and CAR-T therapy using the HM-PRO questionnaire (Impact Scale, Symptoms Scale) from admission to hospital discharge
Time frame: 3 MONTHS
The primary outcome aims to evaluate the impact of CAR-T therapy and allogeneic transplantation on patients' quality of life using a specific questionnaire (HM-PRO), which assesses PROs (quality of life and symptoms) in hematologic patients, with the goal of determining whether there are differences between the two patient groups. In the HM-PRO questionnaire values range from 0 to 100. Lower values correspond to a better quality of life and a lower symptom burden.
5 secondary outcomes
To describe PRO trajectories during hospitalization
Time frame: 3 MONTHS
To assess differences in PROs based on disease type (e.g., Leukemia, lymphoma, myeloma)
Time frame: 3 MONTHS
To assess differences in PROs based on disease status (remission vs progression)
Time frame: 3 MONTHS
To assess differences in PROs based on treatment line (first-line vs multiple lines)
Time frame: 3 MONTHS
To validate the use of the HM-PRO in the context of inpatient care for advanced therapies.
Time frame: 3 MONTHS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Patient Reported Outcome (PRO), run by Associazione Qol-one.
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 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: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
To assess and compare short-term patient-reported outcomes [PROs (symptom burden and QoL impact)] between patients receiving allo-SCT and CAR-T therapy using the HM-PRO questionnaire (Impact Scale, Symptoms Scale) from admission to hospital discharge (time frame: 3 MONTHS). 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 17 Dec 2025.