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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA222014 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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This research study is evaluating the impact of early involvement of a palliative care team working with the transplant oncology team will have on the quality of life, symptoms, and mood of patients undergoing stem cell transplantation.
The Participant has a type of blood cancer and will be undergoing stem cell transplantation. Frequently people undergoing stem cell transplantation experience physical and emotional symptoms during the course of their hospitalization for stem cell transplantation. These can be very distressing to both patient and the family members. The study doctors want to know if the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these distressing symptoms may improve the participant overall care.
This team of clinicians is called the palliative care team and they focus on ways to improve the participant pain and other symptom management (nausea, fatigue, shortness of breath, anxiety, etc.) and to assist the participant and the participant's family in coping with the emotional and social issues associated with your diagnosis. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness.
The main purpose of this study is to compare two types of care - standard transplant oncology care and standard transplant oncology care with early involvement of palliative care clinicians to see which is better for improving the experience of patients and families with blood cancers undergoing stem cell transplantation.
The purpose of this research study is to find out whether introducing patients and families undergoing stem cell transplantation to the palliative care team that specializes in symptom management can improve the physical and psychological symptoms that patients and families experience during hospitalization for stem cell transplantation.
The study will use a series of questionnaires to measure the participant and the participant 's caregivers' quality of life, physical symptoms, and mood. Study questionnaires will be completed in the hospital or clinic with assistance provided as need.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inpatient Palliative Care Intervention | Experimental |
|
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| Transplant Care Alone | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Care Intervention | Other | team of clinicians that specialize in the lessening (palliation) of many distressing symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Quality of Life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) | Compare patient QOL using the Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) scores at week 2 between the study groups Score range 0-164 with higher score indicating better quality of life | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' Quality of Life (QOL) Longitudinally: FACT-BMT | Compare patients' QOL using Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) longitudinally between the study groups Score range 0-164, with higher score indicating better quality of life | up to 6 months |
| Patients' Symptom Burden |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Coping | Compare patient coping using the Brief Cope questionnaire between the study groups We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy. | up to 1 year |
Inclusion Criteria:
Patient Inclusion Criteria
Caregiver Eligibility Criteria:
Exclusion Criteria:
Patient Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Areej El-Jawahri, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40549982 | Derived | El-Jawahri A, LeBlanc TW, Kavanaugh A, Webb J, Fausto J, Traeger L, Greer JA, Jackson V, Horick N, Rabideau DJ, Fenech A, Newcomb R, Ufere NN, Caruso E, Pepper J, DeFilipp Z, Chen YB, Lee SJ, Temel JS. Multisite Randomized Trial of Inpatient Palliative Care Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation. J Clin Oncol. 2025 Aug 20;43(24):2700-2711. doi: 10.1200/JCO-25-00378. Epub 2025 Jun 23. | |
| 39908568 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Inpatient Palliative Care Intervention Patients |
|
| FG001 | Transplant Care Alone Patients |
Standard Transplant Care: Standard care per hospital guidelines |
| FG002 | Inpatient Palliative Care Caregivers | Patients enrolled in the study and randomized to inpatient palliative care can identify a caregiver who is willing to participate in the study. Patients without an eligible caregiver are still eligible to participate. Caregivers will receive the palliative care intervention based on the patient assignment. Caregivers will be allowed to attend palliative care visits with the patients. |
| FG003 | Transplant Care Alone Caregivers | Caregivers of patients randomized to transplant care alone will receive standard transplant care offered by the hospital. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inpatient Palliative Care Intervention - Patients |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient-reported Quality of Life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) | Compare patient QOL using the Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) scores at week 2 between the study groups Score range 0-164 with higher score indicating better quality of life | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
Up to 6 months after enrollment
Given that this is a supportive care study, the protocol a priori specified that only averse events that are related to the study intervention or treatment would be reported. This is standard for supportive care trial in high-risk population where outcomes such as hospitalization/death are expected, but are not related to the study. That is how adverse events were defined and reported in this trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inpatient Palliative Care Intervention Patient |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Areej El-Jawahri | Massachusetts General Hospital | 617-724-4000 | ael-jawahri@mgb.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2020 | Oct 2, 2023 | Prot_SAP_000.pdf |
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| Standard Transplant Care | Other | Standard care per hospital guidelines |
|
Compare patients' symptoms using the revised Edmonton Symptom Assessment Scale (ESAS) scores between the study groups score range 0-100 with higher score indicating worse symptom burden |
| up to 6 months |
| Patients' Fatigue | Compare patients' fatigue using Functional Assessment of Cancer Therapy- Fatigue (FACT-fatigue) scores between the study groups score range from 0-52 with higher scores indicating lower fatigue symptoms | up to 6 months |
| Patients' Psychological Distress | Compare patients' depression and anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS) between the study groups The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress) | up to 6 months |
| Patients' Depression | Compare patients' depression using Patient-Health Questionnaire - 9 (PHQ-9) between the study groups the PHQ-9 score ranges from 0-27, with higher score indicative more depressive symptoms | up to 6 months |
| Patients' Post-traumatic Stress Symptoms (PTSD) | Compare patients' post-traumatic stress symptoms using the PTSD Checklist- Civilian version (PCL-C) between the study groups PCL-C score ranges from 17-85 with higher scores indicating worse PTSD symptoms | up to 6 months |
| Caregiver QOL: CARGOQOL | Compare caregivers' QOL using caregiver oncology QOL questionnaire (CARGOQOL) scores between the study groups the caregiver oncology QOL questionnaire ranges from 0-116 with higher scores indicating better caregiver QOL. | up to 6 months |
| Caregiver Psychological Distress | Compare caregivers' psychological distress using hospital anxiety and depression scale (HADS) between the study groups the HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress) | up to 6 months |
| Caregiver Depression | Compare caregivers' depression symptoms using the Patient Health Questionnaire - 9 (PHQ-9) between the study groups the PHQ-9 score ranges from 0-27 with higher scores indicating worse depression symptoms. | up to 6 months |
| Caregiver Coping | compare caregiver coping (Brief Cope) between the study groups. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy. | up to 1 year |
| Mediation Analysis (Symptom Burden and Coping) as Mediators of Improvement in Patient-reported QOL | mediation analysis (mediation analyses are common in these types of studies, there is no novel new outcome measure here, but rather examining mediation) | 2 week |
| Moderation Analysis to Examine Whether Patient or Transplant Related Characteristics Are Moderators of the Effect of the Intervention on Patient-reported QOL | moderation analysis (moderation analyses are common in these types of studies. there is no new novel outcome measure here, bur rather examining moderation) | 2 week |
| Durham |
| North Carolina |
| 27705 |
| United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Newcomb R, Amonoo HL, Kavanaugh AR, Wharton KC, Rowland M, Fausto J, Webb J, Jackson V, Greer JA, Temel JS, Lark P, Rabideau DJ, O'Brien K, LeBlanc TW, Lee SJ, El-Jawahri A. Factors associated with early quality-of-life response to palliative care during hematopoietic cell transplantation. Blood Adv. 2025 May 13;9(9):2033-2043. doi: 10.1182/bloodadvances.2024014574. |
| 38280483 | Derived | Yang D, Newcomb R, Kavanaugh AR, Khalil D, Greer JA, Chen YB, DeFilipp Z, Temel J, Lee SJ, LeBlanc TW, El-Jawahri A. Protocol for multi-site randomized trial of inpatient palliative care for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation. Contemp Clin Trials. 2024 Mar;138:107460. doi: 10.1016/j.cct.2024.107460. Epub 2024 Jan 26. |
| 38181820 | Derived | Newcomb R, Amonoo HL, Nelson AM, Choe J, Holmbeck K, Nabily A, Lee SJ, LeBlanc TW, El-Jawahri A. Coping in patients with hematologic malignancies undergoing hematopoietic cell transplantation. Blood Adv. 2024 Mar 26;8(6):1369-1378. doi: 10.1182/bloodadvances.2023011081. |
| BG001 | Transplant Care Alone - Patients |
Standard Transplant Care: Standard care per hospital guidelines |
| BG002 | Inpatient Palliative Care - Caregivers | - Caregivers will be randomized based on the patient's randomization. they complete baseline assessment. if the patient is randomized to the palliative care intervention, the caregiver is also considered in this arm. they are permitted to attend the palliative care visits with the patients during hospitalization for transplant. |
| BG003 | Transplant Care Alone- Caregivers | Caregivers complete baseline assessments and are randomized based on the random assignment of the patient. if the patient is randomized to standard transplant care, then the caregiver is randomized to standard transplant care. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Transplant Care Alone |
Standard Transplant Care: Standard care per hospital guidelines |
|
|
| Secondary | Patients' Quality of Life (QOL) Longitudinally: FACT-BMT | Compare patients' QOL using Functional Assessment of Cancer Therapy- Bone Marrow Transplant (FACT-BMT) longitudinally between the study groups Score range 0-164, with higher score indicating better quality of life | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
| Secondary | Patients' Symptom Burden | Compare patients' symptoms using the revised Edmonton Symptom Assessment Scale (ESAS) scores between the study groups score range 0-100 with higher score indicating worse symptom burden | at week-2 | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
| Secondary | Patients' Fatigue | Compare patients' fatigue using Functional Assessment of Cancer Therapy- Fatigue (FACT-fatigue) scores between the study groups score range from 0-52 with higher scores indicating lower fatigue symptoms | week-2 analyses | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
| Secondary | Patients' Psychological Distress | Compare patients' depression and anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS) between the study groups The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress) | depression at week-2 | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
| Secondary | Patients' Depression | Compare patients' depression using Patient-Health Questionnaire - 9 (PHQ-9) between the study groups the PHQ-9 score ranges from 0-27, with higher score indicative more depressive symptoms | depression (PHQ-9) by week-2 | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
| Secondary | Patients' Post-traumatic Stress Symptoms (PTSD) | Compare patients' post-traumatic stress symptoms using the PTSD Checklist- Civilian version (PCL-C) between the study groups PCL-C score ranges from 17-85 with higher scores indicating worse PTSD symptoms | analyses at week-2 | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
| Secondary | Caregiver QOL: CARGOQOL | Compare caregivers' QOL using caregiver oncology QOL questionnaire (CARGOQOL) scores between the study groups the caregiver oncology QOL questionnaire ranges from 0-116 with higher scores indicating better caregiver QOL. | at week-2 | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
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| Secondary | Caregiver Psychological Distress | Compare caregivers' psychological distress using hospital anxiety and depression scale (HADS) between the study groups the HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress) | caregiver anxiety at week-2 | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
|
| Secondary | Caregiver Depression | Compare caregivers' depression symptoms using the Patient Health Questionnaire - 9 (PHQ-9) between the study groups the PHQ-9 score ranges from 0-27 with higher scores indicating worse depression symptoms. | week-2 caregiver depression (PHQ-9) | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
|
|
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| Other Pre-specified | Patient Coping | Compare patient coping using the Brief Cope questionnaire between the study groups We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy. | Not Posted | up to 1 year | Participants |
| Other Pre-specified | Caregiver Coping | compare caregiver coping (Brief Cope) between the study groups. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy. | Not Posted | up to 1 year | Participants |
| Other Pre-specified | Mediation Analysis (Symptom Burden and Coping) as Mediators of Improvement in Patient-reported QOL | mediation analysis (mediation analyses are common in these types of studies, there is no novel new outcome measure here, but rather examining mediation) | Not Posted | 2 week | Participants |
| Other Pre-specified | Moderation Analysis to Examine Whether Patient or Transplant Related Characteristics Are Moderators of the Effect of the Intervention on Patient-reported QOL | moderation analysis (moderation analyses are common in these types of studies. there is no new novel outcome measure here, bur rather examining moderation) | Not Posted | 2 week | Participants |
| 0 |
| 180 |
| 0 |
| 180 |
| 0 |
| 180 |
| EG001 | Transplant Care Alone Patient |
Standard Transplant Care: Standard care per hospital guidelines | 0 | 180 | 0 | 180 | 0 | 180 |
| EG002 | Inpatient Palliative Care Intervention Caregiver | - Patients who enroll in the study may identify a caregiver to participate in the trial. The caregiver will follow the randomization of the patient. Caregivers of patients randomized to the palliative care intervention may meet with the palliative care clinicians during the patient's hospitalization for stem cell transplantation | 0 | 101 | 0 | 101 | 0 | 101 |
| EG003 | Transplant Care Alone Caregivers | -patients who enroll in the study may identify a caregiver to participate in the trial. The caregiver will follow the randomization of the patient. Caregivers of patients randomized to transplant care alone will receive usual transplant care per hospital guidelines. | 0 | 85 | 0 | 85 | 0 | 85 |
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