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Quality of Life Strategies After Stem Cell Transplant for Blood Diseases

Phase 2 & 3
Recruiting
Led By Mohamed Sorror
Research Sponsored by Fred Hutchinson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients considered or referred for allogeneic HCT to treat a hematological malignant or non-malignant disease
Planned allogeneic HCT within 3 weeks - all types of donors and all sorts of conditioning regimens are allowed. Patients with suspected active disease (relatively old disease staging or relatively old intervention) or significant comorbidity (e.g. suspicious untreated pulmonary nodules) based on prior evaluations, that could delay the transplant would be considered for enrollment within a tighter window (10-14 days before allogeneic HCT) to allow for completed pre-HCT work-up evaluations that would confirm readiness to proceed with transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is studying two different approaches to see which one is better in improving quality of life and survival for patients who have undergone a stem cell transplant.

Who is the study for?
This trial is for older, weak, or frail patients with blood diseases who are about to receive a donor stem cell transplant. Participants must be 65+, able to speak and read English, have good heart and lung function without needing extra oxygen, and be willing to consent. They should also have certain health scores indicating comorbidities or frailty based on walking speed tests.Check my eligibility
What is being tested?
The study compares supportive palliative care (SPC), clinical management of comorbidities (CMC), or both against standard care in improving life quality and survival after stem cell transplants. SPC addresses stress relief from illness while CMC manages other diseases through exercise, medication, diet, etc.See study design
What are the potential side effects?
While the trial focuses on non-medication interventions like exercise and stress reduction which typically have minimal side effects compared to drugs, there may still be risks associated with changes in physical activity levels or potential emotional distress from palliative discussions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am being considered for a stem cell transplant to treat my blood disease.
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I am scheduled for a stem cell transplant from a donor within 3 weeks.
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My health score is 3 or higher, making me eligible for a cell transplant.
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I can walk up stairs without needing extra oxygen.
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I am 65 years old or older.
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I am over 50 and walk slower than 0.8 meters per second.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HRQOL (Phase III)
Improvement in health-related quality of life (HRQOL) (Phase II)
Survival after hematopoietic cell transplantation (HCT) (Phase III)
Secondary outcome measures
Cumulative incidence of disability
Cumulative incidence of frailty
Cumulative incidence of relapse
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (SPC and CMC)Experimental Treatment6 Interventions
Patients undergo interventions as outlined in Arm I and Arm II. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT.
Group II: Arm II (CMC)Experimental Treatment5 Interventions
Patients undergo a CMC program on days -15 to 56. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT.
Group III: Arm I (SPC)Experimental Treatment5 Interventions
Patients undergo SPC on days -15 before to +56 after transplant. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT.
Group IV: Arm IV (standard of care)Active Control4 Interventions
Patients receive standard of care. Patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment, 30, 90, 180, and 365 days post HCT. Patients complete a 4-meter walk test, 6-minute walk test, up and go test, measured strength test and cognitive assessment at enrollment, 90, 180, and 365 days post HCT. Patients may also complete surveys on medical and non-medical (transportation, lodging) costs related to transplant after HCT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,342,596 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,685 Previous Clinical Trials
6,930,176 Total Patients Enrolled
2 Trials studying Blood Cancers
207 Patients Enrolled for Blood Cancers
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
147,625 Total Patients Enrolled

Media Library

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT03870750 — Phase 2 & 3
Blood Cancers Research Study Groups: Arm II (CMC), Arm I (SPC), Arm III (SPC and CMC), Arm IV (standard of care)
Blood Cancers Clinical Trial 2023: Allogeneic Hematopoietic Stem Cell Transplantation Highlights & Side Effects. Trial Name: NCT03870750 — Phase 2 & 3
Allogeneic Hematopoietic Stem Cell Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03870750 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people still join this trial program?

"Indeed, this trial is currently looking for 600 patients from 7 different locations, according to the information available on clinicaltrials.gov."

Answered by AI

Could you tell me how many trial sites there are in total?

"Presently, this trial is running in Seattle, Houston, Palo Alto, and 7 other cities. To limit participant burden, it is ideal to pick a location nearest you."

Answered by AI

What are the researchers hoping to learn from this clinical trial?

"The primary objective of this study is to evaluate survival rates after hematopoietic cell transplantation (HCT). Secondary objectives include duration of stay in the intensive care unit (ICU), cumulative incidence of relapse, and overall survival rates. Data will be collected over a period of Baseline to 90 days post-HCT, and comparisons will be made between the different experimental arms and the usual care only (UCO) arm using the log-rank test."

Answered by AI
~133 spots leftby Jun 2025