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Identifying Best Approach in Improving Quality of Life and Survival After a Donor Stem Cell Transplant in Older, Medically Infirm, or Frail Patients With Blood Diseases

NCT03870750 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2026-01-12

No results posted yet for this study

Summary

This phase II/III trial studies the best approach in improving quality of life and survival after a donor stem cell transplant in older, weak, or frail patients with blood diseases. Patients who have undergone a transplant often experience increases in disease and death. One approach, supportive and palliative care (SPC), focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects. While a second approach, clinical management of comorbidities (CMC) focuses on managing multiple diseases, other than cancer, such as heart or lung diseases through physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education. Giving SPC, CMC, or a combination of both may work better in improving quality of life and survival after a donor stem cell transplant compared to standard of care in patients with blood diseases.

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Non-Neoplastic Hematologic and Lymphocytic Disorder

Interventions

OTHER

Supportive Palliative Care

focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects

OTHER

Clinical Management

physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education

OTHER

Best Practice

Given standard of care

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo HCT

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Survey Administration

Complete surveys

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Mohamed Sorror, MD, MSc · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03870750 on ClinicalTrials.gov