← Back to Search

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

Having Hematopoietic Cell Transplantation - Comorbidity Index (HCT-CI) scores of >= 3 (for patients that could be 20 years old and older)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I am being considered for a stem cell transplant to treat my blood disease.

Select...

My health score is 3 or higher, making me eligible for a cell transplant.

Select...

I am 65 years old or older.

Select...

I am over 50 and walk slower than 0.8 meters per second.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in HRQOL (Phase III)

Improvement in health-related quality of life (HRQOL) (Phase II)

Secondary study objectives

Cumulative incidence of disability

Cumulative incidence of frailty

Cumulative incidence of relapse

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1240

0 / 4Eligibility criteria met