Trial Outcomes & Findings for Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation (NCT NCT03244826)

Last Updated: 2024-08-16

Results Overview

Functional Assessment of Cancer Therapy - Bone Marrow Transplantation TOTAL score. The TOTAL score is a summed combination of the Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB) and Bone Marrow Transplant Subscales (BMTS). Higher scores (range: 0 - 148) represent better transplant-related quality of life. It was selected by a consensus of patient stakeholders as a patient-reported outcome (PRO) for the trial.

Recruitment status

COMPLETED

Study phase

Target enrollment

404 participants

Primary outcome timeframe

180 days

Results posted on

2024-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	Shared Care * For the first 90 days, patients alternate between local oncologist and DFCI for weekly visits. * From 90 to 180 days, patients alternate between local and DFCI every 2-3 weeks. * Shared Care include the following * Formal Care Coordination Plan * Patient Engagement and Education * Local Oncologist Engagement and Education * Patient/Local Oncologist/Transplant Oncologist Web Portal Shared Care: Shared Care involves four specific strategies to allow patients to have a portion of their care locally after HCT, where clinic and laboratory visits are equally shared between the local oncologist and primary HCT team	Usual Care * Patients receive all follow-up care at DFCI only, which is currently the Standard Care. * Majority of routine visits in first 180 days will be at DFCI. Standard Care: The usual care provided by the transplant center at DFCI.
Overall Study STARTED	166	160
Overall Study COMPLETED	152	150
Overall Study NOT COMPLETED	14	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Shared Care * For the first 90 days, patients alternate between local oncologist and DFCI for weekly visits. * From 90 to 180 days, patients alternate between local and DFCI every 2-3 weeks. * Shared Care include the following * Formal Care Coordination Plan * Patient Engagement and Education * Local Oncologist Engagement and Education * Patient/Local Oncologist/Transplant Oncologist Web Portal Shared Care: Shared Care involves four specific strategies to allow patients to have a portion of their care locally after HCT, where clinic and laboratory visits are equally shared between the local oncologist and primary HCT team	Usual Care * Patients receive all follow-up care at DFCI only, which is currently the Standard Care. * Majority of routine visits in first 180 days will be at DFCI. Standard Care: The usual care provided by the transplant center at DFCI.
Overall Study Withdrawal by Subject	2	0
Overall Study Transplant delayed or withdrawn	12	10

Baseline Characteristics

Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Shared Care n=152 Participants * For the first 90 days, patients alternate between local oncologist and DFCI for weekly visits. * From 90 to 180 days, patients alternate between local and DFCI every 2-3 weeks. * Shared Care include the following * Formal Care Coordination Plan * Patient Engagement and Education * Local Oncologist Engagement and Education * Patient/Local Oncologist/Transplant Oncologist Web Portal Shared Care: Shared Care involves four specific strategies to allow patients to have a portion of their care locally after HCT, where clinic and laboratory visits are equally shared between the local oncologist and primary HCT team	Usual Care n=150 Participants * Patients receive all follow-up care at DFCI only, which is currently the Standard Care. * Majority of routine visits in first 180 days will be at DFCI. Standard Care: The usual care provided by the transplant center at DFCI.	Total n=302 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	62 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	64 Participants n=7 Participants	117 Participants n=5 Participants
Sex: Female, Male Male	99 Participants n=5 Participants	86 Participants n=7 Participants	185 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	141 Participants n=5 Participants	136 Participants n=7 Participants	277 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	152 participants n=5 Participants	150 participants n=7 Participants	302 participants n=5 Participants
Human leukocyte antigen (HLA) type Matched Unrelated	87 Participants n=5 Participants	94 Participants n=7 Participants	181 Participants n=5 Participants
Human leukocyte antigen (HLA) type Matched Related	28 Participants n=5 Participants	19 Participants n=7 Participants	47 Participants n=5 Participants
Human leukocyte antigen (HLA) type Mismatched	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Human leukocyte antigen (HLA) type Unknown/Other	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: 180 days

Population: Participants with complete FACT-BMT responses sufficient to calculate the total FACT-BMT score.

Outcome measures

Outcome measures
Measure	Shared Care n=86 Participants * For the first 90 days, patients alternate between local oncologist and DFCI for weekly visits. * From 90 to 180 days, patients alternate between local and DFCI every 2-3 weeks. * Shared Care include the following * Formal Care Coordination Plan * Patient Engagement and Education * Local Oncologist Engagement and Education * Patient/Local Oncologist/Transplant Oncologist Web Portal Shared Care: Shared Care involves four specific strategies to allow patients to have a portion of their care locally after HCT, where clinic and laboratory visits are equally shared between the local oncologist and primary HCT team	Usual Care n=86 Participants * Patients receive all follow-up care at DFCI only, which is currently the Standard Care. * Majority of routine visits in first 180 days will be at DFCI. Standard Care: The usual care provided by the transplant center at DFCI.
Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) at Day 180	110.68 score on a scale Standard Deviation 18.34	106.89 score on a scale Standard Deviation 20.42

PRIMARY outcome

Timeframe: 180 days

Population: Participants with complete EORTC QLQ-C30 response sufficient to calculate global score.

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer GLOBAL health status subscale. Higher values (range: 0 to 100) represent higher quality of life. This was selected by a consensus of patient stakeholders.

Outcome measures

Outcome measures
Measure	Shared Care n=70 Participants * For the first 90 days, patients alternate between local oncologist and DFCI for weekly visits. * From 90 to 180 days, patients alternate between local and DFCI every 2-3 weeks. * Shared Care include the following * Formal Care Coordination Plan * Patient Engagement and Education * Local Oncologist Engagement and Education * Patient/Local Oncologist/Transplant Oncologist Web Portal Shared Care: Shared Care involves four specific strategies to allow patients to have a portion of their care locally after HCT, where clinic and laboratory visits are equally shared between the local oncologist and primary HCT team	Usual Care n=73 Participants * Patients receive all follow-up care at DFCI only, which is currently the Standard Care. * Majority of routine visits in first 180 days will be at DFCI. Standard Care: The usual care provided by the transplant center at DFCI.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30) at Day 180	68.93 score on a scale Standard Deviation 20.6	67.01 score on a scale Standard Deviation 20.76

PRIMARY outcome

Timeframe: 100 days

Non-relapse mortality is a common measure to assess early outcomes for stem cell transplant, given that there can be a high level of early mortality from the transplant itself even in the absence of relapse. It is defined as a death occurring while in continuous remission. NRM is reported as a binary outcome.

Outcome measures

Outcome measures
Measure	Shared Care n=152 Participants * For the first 90 days, patients alternate between local oncologist and DFCI for weekly visits. * From 90 to 180 days, patients alternate between local and DFCI every 2-3 weeks. * Shared Care include the following * Formal Care Coordination Plan * Patient Engagement and Education * Local Oncologist Engagement and Education * Patient/Local Oncologist/Transplant Oncologist Web Portal Shared Care: Shared Care involves four specific strategies to allow patients to have a portion of their care locally after HCT, where clinic and laboratory visits are equally shared between the local oncologist and primary HCT team	Usual Care n=150 Participants * Patients receive all follow-up care at DFCI only, which is currently the Standard Care. * Majority of routine visits in first 180 days will be at DFCI. Standard Care: The usual care provided by the transplant center at DFCI.
100-day Non-relapse Mortality (NRM) for Patients in Shared Care Versus Usual Care	4 Participants	4 Participants

Adverse Events

Shared Care

Serious events: 0 serious events

Other events: 47 other events

Deaths: 9 deaths

Usual Care

Serious events: 0 serious events

Other events: 45 other events

Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Shared Care n=152 participants at risk * For the first 90 days, patients alternate between local oncologist and DFCI for weekly visits. * From 90 to 180 days, patients alternate between local and DFCI every 2-3 weeks. * Shared Care include the following * Formal Care Coordination Plan * Patient Engagement and Education * Local Oncologist Engagement and Education * Patient/Local Oncologist/Transplant Oncologist Web Portal Shared Care: Shared Care involves four specific strategies to allow patients to have a portion of their care locally after HCT, where clinic and laboratory visits are equally shared between the local oncologist and primary HCT team	Usual Care n=150 participants at risk * Patients receive all follow-up care at DFCI only, which is currently the Standard Care. * Majority of routine visits in first 180 days will be at DFCI. Standard Care: The usual care provided by the transplant center at DFCI.
Blood and lymphatic system disorders Grade II-IV aGVHD D100	17.1% 26/152 • Number of events 26 • Acute graft-versus-host disease (aGVHD), all-cause mortality and non-relapse mortality (NRM) was collected for the first 100 days of participation (until Day 100). Adverse event collection was limited to collection of aGVHD and NRM and graded on clinical scales. No other adverse events were collected.	14.7% 22/150 • Number of events 22 • Acute graft-versus-host disease (aGVHD), all-cause mortality and non-relapse mortality (NRM) was collected for the first 100 days of participation (until Day 100). Adverse event collection was limited to collection of aGVHD and NRM and graded on clinical scales. No other adverse events were collected.
Blood and lymphatic system disorders Grade I aGVHD D100	13.8% 21/152 • Number of events 21 • Acute graft-versus-host disease (aGVHD), all-cause mortality and non-relapse mortality (NRM) was collected for the first 100 days of participation (until Day 100). Adverse event collection was limited to collection of aGVHD and NRM and graded on clinical scales. No other adverse events were collected.	15.3% 23/150 • Number of events 23 • Acute graft-versus-host disease (aGVHD), all-cause mortality and non-relapse mortality (NRM) was collected for the first 100 days of participation (until Day 100). Adverse event collection was limited to collection of aGVHD and NRM and graded on clinical scales. No other adverse events were collected.

Additional Information

Dr. Gregory Abel (Principal Investigator)

Dana-Farber Cancer Institute

Phone: 617-632-1906

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place