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
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| ClinicalTrials.gov Identifier: NCT03870750 |
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Recruitment Status :
Recruiting
First Posted : March 12, 2019
Last Update Posted : November 26, 2021
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Sponsor:
Fred Hutchinson Cancer Research Center
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm Non-Neoplastic Hematologic and Lymphocytic Disorder | Other: Supportive Palliative Care Other: Clinical Management Other: Best Practice Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Other: Questionnaire Administration Other: Quality-of-Life Assessment Other: Survey Administration | Phase 2 Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Supportive Care |
| Official Title: | 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 |
| Actual Study Start Date : | August 15, 2019 |
| Estimated Primary Completion Date : | June 30, 2025 |
| Estimated Study Completion Date : | June 30, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Blood Disorders
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I (SPC)
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.
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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 Names:
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Undergo HCT
Other Names:
Other: Questionnaire Administration Ancillary studies Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Survey Administration Ancillary studies |
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Experimental: Arm II (CMC)
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..
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Other: Clinical Management
physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Undergo HCT
Other Names:
Other: Questionnaire Administration Ancillary studies Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Survey Administration Ancillary studies |
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Experimental: Arm III (SPC and CMC)
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.
|
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 Names:
Other: Clinical Management physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Undergo HCT
Other Names:
Other: Questionnaire Administration Ancillary studies Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Survey Administration Ancillary studies |
|
Active Comparator: Arm IV (standard of care)
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.
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Other: Best Practice
Given standard of care
Other Names:
Other: Questionnaire Administration Ancillary studies Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Survey Administration Ancillary studies |
Primary Outcome Measures :
- Improvement in health-related quality of life (HRQOL) (Phase II) [ Time Frame: First 90 days after HCT ]The arm with the largest mean change in Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) from baseline to day 90. The Wilcoxon rank-sum test will be used to compare change in FACT-BMT between arms, and this will also be the test to be used in computation of the conditional power at the end of phase II.
- Survival after hematopoietic cell transplantation (HCT) (Phase III) [ Time Frame: At 1 year after HCT ]
- Change in HRQOL (Phase III) [ Time Frame: Baseline to 90 days post-HCT ]Will be measured by the FACT-BMT.
Secondary Outcome Measures :
- Rate of overall survival [ Time Frame: Up to 1 year ]Overall survival will be compared between each of the experimental arms and the usual care only (UCO) arm using the log-rank test. Arms that do not survive the screening phase will also be included for comparison.
- Non-relapse mortality [ Time Frame: At 90 days and up to 1 year ]Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; analysis of variance (ANOVA) or Kruskal-Wallis test for comparisons involving more than two groups). Will use generalized estimating equations (GEEs) approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
- Cumulative incidence of relapse [ Time Frame: Up to 1 year ]Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
- Relapse-free survival [ Time Frame: Up to 1 year ]Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
- Cumulative incidence of frailty [ Time Frame: Up to 1 year ]Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
- Cumulative incidence of disability [ Time Frame: Up to 1 year ]Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
- Frequency of hospitalization [ Time Frame: Up to 90 days after HCT ]Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
- Duration of each hospitalization [ Time Frame: Up to 90 days after HCT ]Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
- Number of admissions to intensive care unit [ Time Frame: Up to 90 days after HCT ]Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
- Duration of admissions to intensive care unit [ Time Frame: Up to 90 days after HCT ]Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
- Days out of hospital alive [ Time Frame: Up to 90 days after HCT ]Will be compared between arms using appropriate tests for continuous data (two-sample t-test or Wilcoxon rank-sum test, as appropriate for two-group comparisons; ANOVA or Kruskal-Wallis test for comparisons involving more than two groups). Will use GEEs approach for regression models, which can accommodate the within patient correlation structure and arbitrary patterns of missing data and also allow for the population average interpretation.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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Vulnerable patients as defined by one or more of the following criteria
- Age 65 years or older
- Having Hematopoietic Cell Transplantation - Comorbidity Index (HCT-CI) scores of >= 3 (for patients that could be 20 years old and older)
- Having frailty as determined by walk speed of < 0.8 m/s using 4-meter walk test (for patients that could be 40 years old and older)
- Patients considered or referred for allogeneic HCT to treat a hematological malignant or non-malignant disease
- Able to speak and read English - interaction with the interventionist trainer and endpoint measurement must occur in English
- Willing and able to provide informed consent
- 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
- Able to exercise at low to moderate intensity, specifically taking into consideration the rare circumstances where subjects are not able to exercise due to either birth deformity or prior traumatic injury that affects their gait
- Adequate cardiopulmonary reserve, as judged by data from the patient's electronic medical record as to whether a patient could walk up one flight of stairs, no need for supplemental oxygen, and/or physician judgment
Exclusion Criteria:
- Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility
- Participation in another intervention clinical trial with HRQOL as a primary endpoint
- Planned donor lymphocyte infusion (DLI) within 90 days post-transplant
- Planned anti-cytotoxic therapies, other than tyrosine kinase inhibitors or single-agent monoclonal antibody, or FLT-3 inhibitors within 90 days of post-transplant unless pre-approved by the protocol principal investigator (PI)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870750
Contacts
| Contact: Mohamed Sorror | 206-667-6298 | msorror@fredhutch.org |
Locations
| United States, California | |
| Stanford Cancer Institute Palo Alto | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Laura Johnston 650-723-0822 | |
| Principal Investigator: Laura Johnston | |
| United States, Michigan | |
| Wayne State University/Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Joseph Uberti 313-576-8760 ubertij@karmanos.org | |
| Principal Investigator: Joseph Uberti | |
| United States, Minnesota | |
| University of Minnesota/Masonic Cancer Center | Active, not recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Hassan Alkhateeb Alkhateeb.Hassan@mayo.edu | |
| Principal Investigator: Hassan Alkhateeb | |
| United States, Oregon | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Rachel Cook 503-494-8945 | |
| Principal Investigator: Rachel Cook | |
| United States, Washington | |
| Fred Hutch/University of Washington Cancer Consortium | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Mohamed Sorror 206-667-6298 msorror@fredhutch.org | |
| Principal Investigator: Mohamed Sorror | |
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Investigators
| Principal Investigator: | Mohamed Sorror | Fred Hutch/University of Washington Cancer Consortium |
| Responsible Party: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT03870750 |
| Other Study ID Numbers: |
RG1004746 NCI-2019-01097 ( Registry Identifier: NCI / CTRP ) 9885 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) R01CA227092 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 12, 2019 Key Record Dates |
| Last Update Posted: | November 26, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Hematologic Diseases |