NCT03870750

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

Seamless Phase II-Phase III Randomized Clinical Trial to Identify and Confirm the Most Promising Novel Intervention to Alleviate Morbidity and Mortality After Allogeneic Hematopoietic Cell Transplantation Among Older, Medically Infirm, or Frail Patients With Hematological Diseases

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 458 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OUTLINE: Patients are randomized to 1 of 4 arms. ARM I: Patients undergo SPC on days -15 before to +56 after transplant. ARM II: Patients undergo a CMC program on days -15 before to +56 after transplant. ARM III: Patients undergo interventions as outlined in Arm I and Arm II. ARM IV: Patients receive standard of care. In all arms, patients undergo HCT on day 0 and complete questionnaires and surveys at enrollment and 30, 90, 180, and 365 days post HCT. In all arms 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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-08-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2019-03-12
• Last updated: 2026-01-12

Locations

11 sites across 1 country: United States