Stem Cell Transplant
Conditions
Keywords
Cancer Care
Brief summary
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.
Detailed description
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.
Interventions
team of clinicians that specialize in the lessening (palliation) of many distressing symptoms
Standard care per hospital guidelines
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria * adult patients (≥ 18 years) with hematologic malignancy admitted for autologous or allogeneic HCT. * ability to read and respond to questions in English or Spanish or to complete questionnaires with assistance from an interpreter. Caregiver Eligibility Criteria: * adult (≥ 18 years) relative or a friend of a patient who agrees to participate in the study whom the patient identified as living with them or having in-person contact with him or her at least twice per week. * ability to read and respond to questions in English or Spanish or to complete questionnaires with the assistance of an interpreter.
Exclusion criteria
Patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Quality of Life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) | 2 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' Psychological Distress | up to 6 months | 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) |
| Patients' Post-traumatic Stress Symptoms (PTSD) | up to 6 months | 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 |
| Caregiver QOL: CARGOQOL | up to 6 months | 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. |
| Caregiver Psychological Distress | up to 6 months | 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 Depression | up to 6 months | 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. |
| Patients' Quality of Life (QOL) Longitudinally: FACT-BMT | up to 6 months | 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 |
| Patients' Symptom Burden | up to 6 months | 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 |
| Patients' Fatigue | up to 6 months | 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 |
| Patients' Depression | up to 6 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mediation Analysis (Symptom Burden and Coping) as Mediators of Improvement in Patient-reported QOL | 2 week | mediation analysis (mediation analyses are common in these types of studies, there is no novel new outcome measure here, but rather examining mediation) |
| Moderation Analysis to Examine Whether Patient or Transplant Related Characteristics Are Moderators of the Effect of the Intervention on Patient-reported QOL | 2 week | moderation analysis (moderation analyses are common in these types of studies. there is no new novel outcome measure here, bur rather examining moderation) |
| Caregiver Coping | up to 1 year | 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. |
| Patient Coping | up to 1 year | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inpatient Palliative Care Intervention - Patients * Patients will complete baseline self-report assessments at the time of obtaining informed consent
* Patients randomized to the intervention will receive the palliative care intervention during their hospitalization for transplant in addition to standard transplant care. the palliative care intervention entails having palliative care clinicians see patients at least twice weekly during hospitalization for transplant. | 180 |
| Transplant Care Alone - Patients * Patients will complete baseline self-report assessments at the time of obtaining informed consent.
* Standard Transplant Care
Standard Transplant Care: Standard care per hospital guidelines | 180 |
| 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. | 101 |
| 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. | 85 |
| Total | 546 |
Baseline characteristics
| Characteristic | Inpatient Palliative Care Intervention - Patients | Total | Transplant Care Alone- Caregivers | Inpatient Palliative Care - Caregivers | Transplant Care Alone - Patients |
|---|---|---|---|---|---|
| Age, Continuous | 55.3 years | 55.4 years | 55.1 years | 54.7 years | 55.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 7 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 33 Participants | 3 Participants | 10 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 51 Participants | 3 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 18 Participants | 3 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 11 Participants | 2 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 134 Participants | 425 Participants | 74 Participants | 75 Participants | 142 Participants |
| Sex: Female, Male Female | 72 Participants | 282 Participants | 67 Participants | 78 Participants | 65 Participants |
| Sex: Female, Male Male | 108 Participants | 264 Participants | 18 Participants | 23 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 180 | 0 / 180 | 0 / 101 | 0 / 85 |
| other Total, other adverse events | 0 / 180 | 0 / 180 | 0 / 101 | 0 / 85 |
| serious Total, serious adverse events | 0 / 180 | 0 / 180 | 0 / 101 | 0 / 85 |
Outcome results
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
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inpatient Palliative Care Intervention | Patient-reported Quality of Life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) | 94.69 score on a scale | Standard Deviation 22.5 |
| Transplant Care Alone | Patient-reported Quality of Life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) | 90.09 score on a scale | Standard Deviation 18.76 |
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.
Time frame: up to 6 months
Population: week-2 caregiver depression (PHQ-9)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inpatient Palliative Care Intervention | Caregiver Depression | 4.64 score on a scale | Standard Deviation 4.54 |
| Transplant Care Alone | Caregiver Depression | 4.73 score on a scale | Standard Deviation 4 |
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)
Time frame: up to 6 months
Population: caregiver anxiety at week-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inpatient Palliative Care Intervention | Caregiver Psychological Distress | 6.82 score on a scale | Standard Deviation 4.24 |
| Transplant Care Alone | Caregiver Psychological Distress | 7.84 score on a scale | Standard Deviation 9.13 |
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.
Time frame: up to 6 months
Population: at week-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inpatient Palliative Care Intervention | Caregiver QOL: CARGOQOL | 73.86 score on a scale | Standard Deviation 12.88 |
| Transplant Care Alone | Caregiver QOL: CARGOQOL | 73.51 score on a scale | Standard Deviation 12.53 |
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
Time frame: up to 6 months
Population: depression (PHQ-9) by week-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inpatient Palliative Care Intervention | Patients' Depression | 6.70 score on a scale | Standard Deviation 5.2 |
| Transplant Care Alone | Patients' Depression | 7.07 score on a scale | Standard Deviation 4.91 |
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
Time frame: up to 6 months
Population: week-2 analyses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inpatient Palliative Care Intervention | Patients' Fatigue | 28.3 score on a scale | Standard Deviation 12.65 |
| Transplant Care Alone | Patients' Fatigue | 25.96 score on a scale | Standard Deviation 11.91 |
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
Time frame: up to 6 months
Population: analyses at week-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inpatient Palliative Care Intervention | Patients' Post-traumatic Stress Symptoms (PTSD) | 26.04 score on a scale | Standard Deviation 9.37 |
| Transplant Care Alone | Patients' Post-traumatic Stress Symptoms (PTSD) | 28.17 score on a scale | Standard Deviation 10.91 |
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)
Time frame: up to 6 months
Population: depression at week-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inpatient Palliative Care Intervention | Patients' Psychological Distress | 6.17 score on a scale | Standard Deviation 7.89 |
| Transplant Care Alone | Patients' Psychological Distress | 6.63 score on a scale | Standard Deviation 4.2 |
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
Time frame: up to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inpatient Palliative Care Intervention | Patients' Quality of Life (QOL) Longitudinally: FACT-BMT | 107.8 score on a scale | Standard Deviation 23.85 |
| Transplant Care Alone | Patients' Quality of Life (QOL) Longitudinally: FACT-BMT | 108.8 score on a scale | Standard Deviation 19.64 |
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
Time frame: up to 6 months
Population: at week-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inpatient Palliative Care Intervention | Patients' Symptom Burden | 35.63 score on a scale | Standard Deviation 21.51 |
| Transplant Care Alone | Patients' Symptom Burden | 39.86 score on a scale | Standard Deviation 20.83 |
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.
Time frame: up to 1 year
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)
Time frame: 2 week
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)
Time frame: 2 week
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.
Time frame: up to 1 year