Hematopoietic and Lymphoid Cell NeoplasmNCT04914338
A Multidisciplinary Approach to Improve the Health of Older Adults With Blood Cancers After Stem Cell Transplantation
A study testing Health Promotion, Quality-of-Life Assessment and Questionnaire Administration in people with Hematopoietic and Lymphoid Cell Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This clinical trial studies the usefulness and process of a multidisciplinary intervention, where patients see multiple healthcare professionals, aimed at improving fitness and the ability to bounce back after transplant for older adults with blood cancers planned for stem cell transplantation. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Health Promotion, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2021to 2 Feb 2027
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Documented informed consent of the participant
- >= 65 years at time of planned HCT infusion
- Anticipated to be candidate for allogeneic transplant per treating physician at the time of enrollment
- Ability to read English, Spanish or Mandarin. Other languages will be acceptable with principal investigator (PI) agreement if surveys are available and language does not preclude completing study procedures
- Any conditioning regimen and allogeneic donor permitted
- Hematologic malignancy or disease as indication for HCT
- Willing and able to complete study requirements
Who cannot join
- Prior allogeneic stem cell transplant
- Syngeneic donors for HCT
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Nedical Center
Duarte, California, 91010
About this study
Official title: Feasibility of a Multidisciplinary Approach to Circumvent Healthspan Decline After Allogeneic Hematopoietic Cell Transplantation in Older Patients
This clinical trial studies the usefulness and process of a multidisciplinary intervention, where patients see multiple healthcare professionals, aimed at improving fitness and the ability to bounce back after transplant for older adults with blood cancers planned for stem cell transplantation. Using a multidisciplinary team approach may increase patients' ability to withstand the transplant by optimizing health to better prepare patients for the expected complications after stem cell transplantation.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate the feasibility of delivering a geriatric assessment guided by a multi-disciplinary team (MDT) intervention before allogeneic hematopoietic cell transplantation (HCT) in older patients.
SECONDARY OBJECTIVES:
- Establish successful dose intensity of resiliency bolstering. II. Describe HCT utilization among enrolled patients. III. Create a standardized and exportable library of MDT-facilitated interventions.
IV. Estimate the benefit derived from the MDT approach compared to historic controls for day +100 outcomes of falls, delirium and functional decline.
- Quantify early functionally independent survival (FIS) to estimate HCT-associated health span decline.
EXPLORATORY OBJECTIVES:
- Characterize reasons patients do not undergo HCT after MDT intervention. II. Associate early FIS with 1-year non-relapse mortality (NRM) and overall survival (OS).
III. Integrate virtual assessment and interventions. IV. Correlate image defined sarcopenia with objective function. V. Biobank blood and stool for future studies of accelerated aging.
OUTLINE:
Patients participate in the MDT-intervention including access to a HCT physician, a geriatrician, physical or occupational therapist, dietician, and a social worker for three months before HCT and up to 100 days after HCT.
After completion of study, patients are followed up for up to 1 year.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Being tested
- Health Promotion, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health PromotionOther
Also called Health Promotion (Salutogenesis), Health Promotion and Wellness, Mindfulness Health Promotion, Salutogenesis
Participate in MDT-intervention
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (MDT-intervention) | Experimental | Patients participate in the MDT-intervention including access to a HCT physician, a geriatrician, physical or occupational therapist, dietician, and a social worker for three months before HCT and up to 100 days after HCT. Receives: Other: Health Promotion; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of multidisciplinary team (MDT) (met 90 percent threshould, yes / no)
Patients are expected to see 6 providers. Success is defined as enrolled patients seen at least 4 out of six providers. The study will meet feasibility endpoint if 90 percent or more of the enrolled patients are flagged as successful. Each patient will be measured as success or failure according to these rules.
Measured: Up to 1 year
Secondary outcomes (4)
Dose intensity of resiliency bolstering
Adequate dose intensity arbitrarily will be defined as completion of at least 11 of 16 process metrics (i.e, approximately 70 percent of more of process measures).
Measured: Up to 1 year
Rate of hematopoietic cell transplantation (HCT) utilization
Measured by summarizing proportion of patients proceeding to allogeneic HCT.
Measured: Up to 1 year
Library of MDT-facilitated intervention
Will provide a standardized library of evaluation and interventions from the MDT approach. A manual of procedures will be created and a database to capture metrics. Will be categorized by the MDT in a Likert scale to the following question: "Is the library of MDT-facilitated interventions ready to be exposure for a randomized controlled trial".
Measured: Up to 1 year
Functional independent survival (FIS)
FIS will be calculated as with first observed failure events of intensive care unit admissions, delirium, falls, or frail 4 meter walk at day 30 or day 100. Functional impairment will use the milestones of day 30, day 60 day 100.
Measured: Days 30, 60, 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start3 Jun 2021
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andrew S Artz, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914338
- Sponsor's protocol ID
- 21026
- Other IDs
- NCI-2021-03939, 21026, P30CA033572
- Status last verified
- Mar 2026
- First submitted
- 24 May 2021
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Multidisciplinary Approach to Circumvent Healthspan Decline After Allogeneic Hematopoietic Cell Transplantation in Older Patients
- ClinicalTrials.gov ID
- NCT04914338
- Acronym / sponsor ID
- 21026
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 4 Jun 2021 (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.
This clinical trial studies the usefulness and process of a multidisciplinary intervention, where patients see multiple healthcare professionals, aimed at improving fitness and the ability to bounce back after transplant for older adults with blood cancers planned for stem cell transplantation. Using a multidisciplinary team approach may increase patients' ability to withstand the transplant by optimizing health to better prepare patients for the expected complications after stem cell transplantation.
Detailed description
PRIMARY OBJECTIVE:
- Evaluate the feasibility of delivering a geriatric assessment guided by a multi-disciplinary team (MDT) intervention before allogeneic hematopoietic cell transplantation (HCT) in older patients.
SECONDARY OBJECTIVES:
- Establish successful dose intensity of resiliency bolstering. II. Describe HCT utilization among enrolled patients. III. Create a standardized and exportable library of MDT-facilitated interventions.
IV. Estimate the benefit derived from the MDT approach compared to historic controls for day +100 outcomes of falls, delirium and functional decline.
- Quantify early functionally independent survival (FIS) to estimate HCT-associated health span decline.
EXPLORATORY OBJECTIVES:
- Characterize reasons patients do not undergo HCT after MDT intervention. II. Associate early FIS with 1-year non-relapse mortality (NRM) and overall survival (OS).
III. Integrate virtual assessment and interventions. IV. Correlate image defined sarcopenia with objective function. V. Biobank blood and stool for future studies of accelerated aging.
OUTLINE:
Patients participate in the MDT-intervention including access to a HCT physician, a geriatrician, physical or occupational therapist, dietician, and a social worker for three months before HCT and up to 100 days after HCT.
After completion of study, patients are followed up for up to 1 year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (MDT-intervention) | Experimental | Other: Health Promotion, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients participate in the MDT-intervention including access to a HCT physician, a geriatrician, physical or occupational therapist, dietician, and a social worker for three months before HCT and up to 100 days after HCT. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Documented informed consent of the participant
- >= 65 years at time of planned HCT infusion
- Anticipated to be candidate for allogeneic transplant per treating physician at the time of enrollment
- Ability to read English, Spanish or Mandarin. Other languages will be acceptable with principal investigator (PI) agreement if surveys are available and language does not preclude completing study procedures
- Any conditioning regimen and allogeneic donor permitted
Key exclusion criteria (3 listed)
- Prior allogeneic stem cell transplant
- Syngeneic donors for HCT
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
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 |
|---|---|---|
| Health PromotionAlso: Health Promotion (Salutogenesis), Health Promotion and Wellness, Mindfulness Health Promotion, SalutogenesisParticipate in MDT-intervention | Other | Supportive care (MDT-intervention) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (MDT-intervention) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (MDT-intervention) |
Primary outcome
Feasibility of multidisciplinary team (MDT) (met 90 percent threshould, yes / no)
Time frame: Up to 1 year
Patients are expected to see 6 providers. Success is defined as enrolled patients seen at least 4 out of six providers. The study will meet feasibility endpoint if 90 percent or more of the enrolled patients are flagged as successful. Each patient will be measured as success or failure according to these rules.
4 secondary outcomes
Dose intensity of resiliency bolstering
Time frame: Up to 1 year
Rate of hematopoietic cell transplantation (HCT) utilization
Time frame: Up to 1 year
Library of MDT-facilitated intervention
Time frame: Up to 1 year
Functional independent survival (FIS)
Time frame: Days 30, 60, 100
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 5 Mar 2026.
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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.
Andrew S Artz principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Promotion, Quality-of-Life Assessment and Questionnaire Administration in people with Hematopoietic and Lymphoid Cell Neoplasm, run by City of Hope Medical Center at 1 site in United States.
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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 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 United States. 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?
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?
Feasibility of multidisciplinary team (MDT) (met 90 percent threshould, yes / no) (time frame: Up to 1 year). 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 5 Mar 2026.