Hematopoietic Steam Cell Transplantation (HCT)
Conditions
Brief summary
This is a research study to develop and test a novel protocol to reduce physical and psychological vulnerabilities that contribute to treatment intolerance and treatment-related morbidity and mortality among hematopoietic stem cell transplant (HCT) patients. When the participant enrolls in this study, they will be asked to participate in acceptance and commitment therapy (ACT) as well as complete in-person physical function tests and a cognitive test. They will also receive training on how to use iOS devices (e.g. iPad, iPhone) and activity trackers (e.g. Apple Watch), which will be provided to them during the duration of study participation. The study team will ask you to complete multiple surveys about emotional and cognitive function, diet and social support, and ask the participant to provide feedback about the treatment (e.g., what they liked or did not like). The study team will also ask the participant to provide stool samples for analysis of the bacteria in intestines, skin surface swabs for analysis of the bacteria on skin and blood samples for analysis of biomarkers and metabolites. Biomarkers and metabolites are molecular and cellular parts that deal with genetic makeup, like DNA, RNA, protein, and/or other naturally occurring substances that may be associated with transplant outcomes. Participants can expect to be enrolled in this study for 3 years.
Interventions
BEHAVIORALAcceptance and Commitment Therapy (ACT)
The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient: * Over the age of 18 * Undergoing allogeneic HCT for any cancer or noncancer illness * English speaking * Has a caregiver willing to participate Caregiver: * Over the age of 18 * English speaking
Exclusion criteria
* Under the age of 18 * Non-English speaking * Has a caregiver unwilling to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT) | Baseline (~30 days before HCT), Signoff (~10 days before HCT), Day 90 post-HCT | The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. |
| Hospital Length of Stay, as Measured by Medical Record Review | Up to Day 90 | Hospital length of stay in days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Function, as Measured by 6 Minute Walk Test | Baseline, Day 30, Day 180, Year 1, Year 2, and Year 3 | The baseline for each patient is made through an algorithm that factors the patients age and gender. The patient's score is compared to what a person that is the patient's same age and gender would get. This comparison is then used as a tool to assess aerobic capacity or endurance. |
| Change in Symptom Severity, as Measured by PRO-CTCAE Core Symptom Assessment | Day 0, Year 1 | Assessing changes in severity of core symptoms that are typically associated with HCT |
| Clinical Outcomes, as Assessed by Adverse Events Reporting | Continuous from baseline | Post-HCT clinical outcomes (i.e. GVHD) |
| Acceptability of the Intervention, as Assessed by Exit Interviews | Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | Exit interviews to assess patients' opinion on the ACT program |
| Acceptability of the Intervention, as Assessed by the Acceptability Survey | Baseline, at each ACT session time point | 6-item survey to assess patients' opinion on the ACT program |
| Changes in Flow Cytometry, as Measured by Blood Samples | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | Whole blood samples, will be analyzed and monitored for outcomes such as immune cell differentiation, immune response and development of GVHD. Flow cytometry will be performed. |
| Changes in Metabolomics, as Measured by Blood Samples | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | Approximately 1ml of plasma from the EDTA tube will be used for metabolomics analysis. |
| Changes in Biomarkers, as Measured by Blood Samples | Baseline, Day 14, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | Assays evaluating angiogenic, stromal, and inflammatory markers and markers of aging (the Pepper Panel) are used to assess inflammation and frailty. |
| Change in Microbiome Diversity, as Measured by Skin Swabs | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | Skin swab samples batch sequenced and microbiome analyzed |
| Change in Overall Well-being, as Measured by PROMIS Sleep Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population. |
| Change in Overall Well-being, as Measured by PROMIS Global Health Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population. |
| Change in Caregiver Quality of Life, as Measured by Self-Efficacy and Preparedness for Caregivers Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | 9-item questionnaire to assess preparedness for caregiving |
| Change in Quality of Life, as Measured by Lorig Self-Efficacy Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The Self-Efficacy to Manage Chronic Disease Scale is made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). |
| Change in Quality of Life, as Measured by EQ-5D-5L Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The 5D represents 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Five levels of severity are measured, as indicated by the 5L, ranging from no problems to extreme problems. All scores are converted into a summary index. |
| Change in Caregiver Quality of Life, as Measured by FACT-GP Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | 21 item assessment scored on a 5-point Likert scale |
| Change in Quality of Life, as Measured by FACT-BMT Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | 50 item assessment. Higher total and domain scores indicate greater quality of life. |
| Change in Overall Well-being, as Measured by OARS IADLs Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | OARS IADL is a 7 item assessment that asks what level of assistance is needed to do 7 different activities of daily living |
| Change in Overall Well-being, as Measured by Fried Frailty Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The scores of all of the sections are added and if the patient has a score greater or equal to three this assessment deems that the patients is frail. If the patient has a score between 1-2 the patient is deemed pre-frail. |
| Change in Financial Status, as Measured by Financial Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | 22-item questionnaire to assess how a patient's care as affected their finances |
| Change in Caregiver Socioeconomic Status, as Measured by SES Assessment | Baseline, D180, Year 1, Year 2, and Year 3 | Questionnaire to assess caregiver socioeconomic status |
| Change in Financial Status, as Measured by COST-FACIT Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | COST-FACIT is an 11-item questionnaire that assesses a patient's financial toxicity |
| Change in Social Well-being, as Measured by CMS Social Determinants of Health (SDOH) Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | CMS SDOH is a 10 item survey that assesses 5 domains of social needs |
| Change in Nutrition, as Measured by ASA-24 Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | ASA-24 is a self-administered 24-hour diet recall |
| Change in Nutrition, as Measured by PG-SGA/Clinician SGA Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | Scores for each section can range from 0-4 depending on severity and nutritional impact. The sum of all scores provides the Total PG-SGA score, which can be used to indicate the need for intervention (Bauer et al., 2002) |
| Change in Nutrition, as Measured by Perioperative Nutrition Screen (PONS) | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | PONS analyzes BMI, weight loss, and food intake to screen for preoperative nutrition risk |
| Change in Nutrition, as Measured by Body Mass Index (BMI) | Continuous from baseline | BMI can be associated with a patient's nutritional health |
| Change in Nutrition, as Measured by Albumin Values | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | Albumin levels can be associated with a patient's nutritional health |
| Change in Mental Health, as Measured by Brief COPE Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | Scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style. |
| Change in Mental Health, as Measured by HHI-12 Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The HHI-12 is an adapted 12 question version of the Hearth Hope Scale that assesses a patient's sense of hope |
| Change in Mental Health, as Measured by PROMIS Social Isolation Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population. |
| Change in Mental Health, as Measured by PROMIS Emotional Support Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population. |
| Change in Mental Health, as Measured by PROMIS Anxiety Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population. |
| Change in Mental Health, as Measured by PROMIS Depression Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population. |
| Change in Mental Health, as Measured by PC-PTSD/PCL-5 Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | PC-PTSD is a 5 item screen to identify patients with probable PTSD. If the patient screens positive, they then take the PCL-5. The PCL-5 is a 20 item screen to assess symptoms of PTSD. |
| Target Engagement (Process of Change), as Assessed by Valuing Questionnaire (VQ) | Baseline, Day 90 | The VQ is a 10-item self-report questionnaire that assesses how closely a person is living in align with their values over the last week. Progress (range = 0 to 30) is defined as enactment and perseverance in living consistently with one's values; higher scores represent a closer alignment between one's internal values and one's actions. Obstruction (range = 0 to 30) represents the extent to which various disruptions got in the way of valued living; higher scores represent more interference with living consistently with one's values. The baseline and day 90 VQ scores are reported. |
| Change in Depression Score, as Measured by PHQ-9 Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The PHQ-9 consists of 9 items, each of which is scored 0 to 3, giving a 0 to 27 severity score |
| Change in Cognitive Function, as Measured by PROMIS Cognitive Function Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population. |
| Change in Cognitive Function, as Measured by Montreal Cognitive Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | This administered assessment is subdivided into visuospatial/executive (5pts), naming (3pts), memory (no points), attention(5pts), language(3pts), abstraction(2pts), delayed recall(5pts), and orientation(6pts). All the subdivided sections have as many questions as they have points. For analysis, the cut point is if the patient has less than 26 points. |
| Change in Physical Function, as Measured by PROMIS Physical Function Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population. |
| Change in Shannon Diversity, as Measured by Stool Samples | Baseline, Day 90 | Stool samples assessed by 16s rRNA sequencing |
| Number of Falls, as Assessed by Falls Questionnaire | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | Participants will answer Yes/No to whether they have had any falls in the preceding 6 months |
| Change in Step Count, as Measured by Activity Tracker | Continuous from baseline up to 3 years | Activity tracker tracks number of steps per day |
| Change in Physical Function, as Measured by 30 Second Sit-stand | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | Subjects will sit in a chair with their arms crossed over their chest and rise to a standing position, then return to seated position. They will repeat this as many times as they can in 30 seconds. |
| Change in Physical Function, as Measured by Short Physical Performance Battery (SPPB) | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | All the task points are added which make the SPPB score. The cut-point for the SPPB is a score of 10. The cumulative and sections scores are assessed individually and comprehensively. This assessment score will be used as a tool for evaluating lower extremity functioning in older persons. |
| Change in Physical Function, as Measured by PROMIS Fatigue Assessment | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population. |
| Hospital Length of Stay, as Measured by Medical Record Review | Up to 3 years | Hospital length of stay in days |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Duke Adult Bone Marrow Transplant program between August 2020 and September 2022. The first subject was consented on October 14, 2020 and the last subject was consented on June 7, 2022.
Pre-assignment details
Five subjects consented to the study but were excluded before starting intervention. One patient's caregiver declined to participate and lack of caregiver participation is an exclusion criteria for this study. One patient was no longer scheduled to receive an allogeneic transplant and they and their caregiver were excluded. One patient relapsed and was no longer getting a transplant and they and their caregiver were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Hematopoietic Stem Cell Transplantation (HCT) Patients 14 HCT patients at Duke
Acceptance and Commitment Therapy (ACT): The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the patient and caregiver. | 14 |
| Caregivers 14 HCT patients' caregivers at Duke
Acceptance and Commitment Therapy (ACT): The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the patient and caregiver. | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Caregiver to patient who died | 0 | 3 |
| Overall Study | Caregiver to patient who withdrew | 0 | 3 |
| Overall Study | Death | 3 | 0 |
| Overall Study | Still on study (but completed primary endpoint) | 8 | 8 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Caregivers | Total | Hematopoietic Stem Cell Transplantation (HCT) Patients |
|---|---|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 11.9 | 55.7 years STANDARD_DEVIATION 13.3 | 53.3 years STANDARD_DEVIATION 14.6 |
| Diagnosis Acute lymphoblastic leukemia | — | 1 Participants | 1 Participants |
| Diagnosis Acute myeloid leukemia | — | 6 Participants | 6 Participants |
| Diagnosis Chronic myeloid leukemia | — | 1 Participants | 1 Participants |
| Diagnosis Diffuse large B cell lymphoma | — | 1 Participants | 1 Participants |
| Diagnosis Myelodysplastic syndrome | — | 2 Participants | 2 Participants |
| Diagnosis Myeloproliferative neoplasm | — | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 24 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 21 Participants | 12 Participants |
| Sex: Female, Male Female | 8 Participants | 15 Participants | 7 Participants |
| Sex: Female, Male Male | 6 Participants | 13 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT)
The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time frame: Baseline (~30 days before HCT), Signoff (~10 days before HCT), Day 90 post-HCT
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Hematopoietic Stem Cell Transplantation (HCT) Patients | Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT) | Day 90 | 478 meters |
| Hematopoietic Stem Cell Transplantation (HCT) Patients | Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT) | Baseline (~30 days before HCT) | 449 meters |
| Hematopoietic Stem Cell Transplantation (HCT) Patients | Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT) | Sign off (~10 days before HCT) | 468 meters |
Primary
Hospital Length of Stay, as Measured by Medical Record Review
Hospital length of stay in days
Time frame: Up to Day 90
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hematopoietic Stem Cell Transplantation (HCT) Patients | Hospital Length of Stay, as Measured by Medical Record Review | 31.4 days | Standard Deviation 27.6 |
Other Pre-specified
Acceptability of the Intervention, as Assessed by Exit Interviews
Exit interviews to assess patients' opinion on the ACT program
Time frame: Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Acceptability of the Intervention, as Assessed by the Acceptability Survey
6-item survey to assess patients' opinion on the ACT program
Time frame: Baseline, at each ACT session time point
Other Pre-specified
Change in Caregiver Quality of Life, as Measured by FACT-GP Assessment
21 item assessment scored on a 5-point Likert scale
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Caregiver Quality of Life, as Measured by Self-Efficacy and Preparedness for Caregivers Assessment
9-item questionnaire to assess preparedness for caregiving
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Caregiver Socioeconomic Status, as Measured by SES Assessment
Questionnaire to assess caregiver socioeconomic status
Time frame: Baseline, D180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Cognitive Function, as Measured by Montreal Cognitive Assessment
This administered assessment is subdivided into visuospatial/executive (5pts), naming (3pts), memory (no points), attention(5pts), language(3pts), abstraction(2pts), delayed recall(5pts), and orientation(6pts). All the subdivided sections have as many questions as they have points. For analysis, the cut point is if the patient has less than 26 points.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Cognitive Function, as Measured by PROMIS Cognitive Function Assessment
The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Depression Score, as Measured by PHQ-9 Assessment
The PHQ-9 consists of 9 items, each of which is scored 0 to 3, giving a 0 to 27 severity score
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Financial Status, as Measured by COST-FACIT Assessment
COST-FACIT is an 11-item questionnaire that assesses a patient's financial toxicity
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Financial Status, as Measured by Financial Assessment
22-item questionnaire to assess how a patient's care as affected their finances
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Mental Health, as Measured by Brief COPE Assessment
Scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Mental Health, as Measured by HHI-12 Assessment
The HHI-12 is an adapted 12 question version of the Hearth Hope Scale that assesses a patient's sense of hope
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Mental Health, as Measured by PC-PTSD/PCL-5 Assessment
PC-PTSD is a 5 item screen to identify patients with probable PTSD. If the patient screens positive, they then take the PCL-5. The PCL-5 is a 20 item screen to assess symptoms of PTSD.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Mental Health, as Measured by PROMIS Anxiety Assessment
The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Mental Health, as Measured by PROMIS Depression Assessment
The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Mental Health, as Measured by PROMIS Emotional Support Assessment
The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Mental Health, as Measured by PROMIS Social Isolation Assessment
The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Microbiome Diversity, as Measured by Skin Swabs
Skin swab samples batch sequenced and microbiome analyzed
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Nutrition, as Measured by Albumin Values
Albumin levels can be associated with a patient's nutritional health
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Nutrition, as Measured by ASA-24 Assessment
ASA-24 is a self-administered 24-hour diet recall
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Nutrition, as Measured by Body Mass Index (BMI)
BMI can be associated with a patient's nutritional health
Time frame: Continuous from baseline
Other Pre-specified
Change in Nutrition, as Measured by Perioperative Nutrition Screen (PONS)
PONS analyzes BMI, weight loss, and food intake to screen for preoperative nutrition risk
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Nutrition, as Measured by PG-SGA/Clinician SGA Assessment
Scores for each section can range from 0-4 depending on severity and nutritional impact. The sum of all scores provides the Total PG-SGA score, which can be used to indicate the need for intervention (Bauer et al., 2002)
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Overall Well-being, as Measured by Fried Frailty Assessment
The scores of all of the sections are added and if the patient has a score greater or equal to three this assessment deems that the patients is frail. If the patient has a score between 1-2 the patient is deemed pre-frail.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Overall Well-being, as Measured by OARS IADLs Assessment
OARS IADL is a 7 item assessment that asks what level of assistance is needed to do 7 different activities of daily living
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Overall Well-being, as Measured by PROMIS Global Health Assessment
The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Overall Well-being, as Measured by PROMIS Sleep Assessment
The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Physical Function, as Measured by 30 Second Sit-stand
Subjects will sit in a chair with their arms crossed over their chest and rise to a standing position, then return to seated position. They will repeat this as many times as they can in 30 seconds.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Physical Function, as Measured by 6 Minute Walk Test
The baseline for each patient is made through an algorithm that factors the patients age and gender. The patient's score is compared to what a person that is the patient's same age and gender would get. This comparison is then used as a tool to assess aerobic capacity or endurance.
Time frame: Baseline, Day 30, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Physical Function, as Measured by PROMIS Fatigue Assessment
The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Physical Function, as Measured by PROMIS Physical Function Assessment
The questions are asked as interval format with 0-Never through 5-Always. Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Physical Function, as Measured by Short Physical Performance Battery (SPPB)
All the task points are added which make the SPPB score. The cut-point for the SPPB is a score of 10. The cumulative and sections scores are assessed individually and comprehensively. This assessment score will be used as a tool for evaluating lower extremity functioning in older persons.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Quality of Life, as Measured by EQ-5D-5L Assessment
The 5D represents 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Five levels of severity are measured, as indicated by the 5L, ranging from no problems to extreme problems. All scores are converted into a summary index.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Quality of Life, as Measured by FACT-BMT Assessment
50 item assessment. Higher total and domain scores indicate greater quality of life.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Quality of Life, as Measured by Lorig Self-Efficacy Assessment
The Self-Efficacy to Manage Chronic Disease Scale is made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident).
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Shannon Diversity, as Measured by Stool Samples
Stool samples assessed by 16s rRNA sequencing
Time frame: Baseline, D0, D7, D14, D21, Day 30, Day 60, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Shannon Diversity, as Measured by Stool Samples
Stool samples assessed by 16s rRNA sequencing
Time frame: Baseline, Day 90
Other Pre-specified
Change in Social Well-being, as Measured by CMS Social Determinants of Health (SDOH) Assessment
CMS SDOH is a 10 item survey that assesses 5 domains of social needs
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Change in Step Count, as Measured by Activity Tracker
Activity tracker tracks number of steps per day
Time frame: Continuous from baseline up to 3 years
Other Pre-specified
Change in Symptom Severity, as Measured by PRO-CTCAE Core Symptom Assessment
Assessing changes in severity of core symptoms that are typically associated with HCT
Time frame: Day 0, Year 1
Other Pre-specified
Changes in Biomarkers, as Measured by Blood Samples
Assays evaluating angiogenic, stromal, and inflammatory markers and markers of aging (the Pepper Panel) are used to assess inflammation and frailty.
Time frame: Baseline, Day 14, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Changes in Flow Cytometry, as Measured by Blood Samples
Whole blood samples, will be analyzed and monitored for outcomes such as immune cell differentiation, immune response and development of GVHD. Flow cytometry will be performed.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Changes in Metabolomics, as Measured by Blood Samples
Approximately 1ml of plasma from the EDTA tube will be used for metabolomics analysis.
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Clinical Outcomes, as Assessed by Adverse Events Reporting
Post-HCT clinical outcomes (i.e. GVHD)
Time frame: Continuous from baseline
Other Pre-specified
Hospital Length of Stay, as Measured by Medical Record Review
Hospital length of stay in days
Time frame: Up to 3 years
Other Pre-specified
Number of Falls, as Assessed by Falls Questionnaire
Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
Time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Other Pre-specified
Target Engagement (Process of Change), as Assessed by Valuing Questionnaire (VQ)
The VQ is a 10-item self-report questionnaire that assesses how closely a person is living in align with their values over the last week. Progress (range = 0 to 30) is defined as enactment and perseverance in living consistently with one's values; higher scores represent a closer alignment between one's internal values and one's actions. Obstruction (range = 0 to 30) represents the extent to which various disruptions got in the way of valued living; higher scores represent more interference with living consistently with one's values. The baseline and day 90 VQ scores are reported.
Time frame: Baseline, Day 90