Hematologic Malignancy
Conditions
Brief summary
The purpose of this study is to evaluate the feasibility and outcomes of a research pre- and peri-transplant optimization program (R-PPOP) to improve multiple domains of health including physical function, cognitive function, mental health, and diet and nutrition for patients planning to undergo or undergoing hematopoietic stem cell transplantation (HCT).
Interventions
BEHAVIORALInterval training
Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise.
BEHAVIORALPsychiatric consult
Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
BEHAVIORALNutrition/diet evaluation
PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
BEHAVIORALReferral to Social Worker
Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: * Plan to undergo an allogeneic hematopoietic stem cell transplant for any cancer or non-cancer illness within the next 6 months * Age 18-80 years Patient
Exclusion criteria
* Both patient and caregiver are unable to read and follow directions in English (ok if only patient cannot read and follow directions in English as caregiver will be able to help). * Any absolute contraindications to exercise: * recent (\< 6 months) acute cardiac event; * unstable angina; * uncontrolled dysrhythmias causing symptoms or hemodynamic compromise; * symptomatic aortic stenosis; * uncontrolled symptomatic heart failure; * acute pulmonary embolus; * acute myocarditis or pericarditis; * suspected or known dissecting aneurism; or * coronary artery disease. * Functional impairment resulting in inability to exercise Caregiver inclusion criteria * Identified by patient as their primary caregiver * Age 18-80 years Caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions | 6 months | Participants were asked to record or report their exercise sessions. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 1 year | — |
| Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Transplant Patients | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730 | — |
| Measuring Changes in the Skin Flora (Microbiome) in Caregivers | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365 | — |
| Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Caregivers | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365 | — |
| Caregiver Quality of Life as Assessed by the Caregiver Strain Questionnaire | 1 year | Scored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe) |
| Quality of Life as Assessed by the FACT-BMT Questionnaire | 1 year | Scored from 0 (least severe) to 4 (most severe) |
| Delirium as Measured by the DOS Assessment | 1 year | — |
| Assessing Falls | 1 year | Participants will answer Yes/No to whether they have had any falls in the preceding 6 months |
| Return to Work as Assessed by the Work Assessment | 1 year | — |
| Transplant Length of Stay | 1 year | — |
| Graft Versus Host Disease (GVHD) | 1 year | — |
| Intensive Care Unit Length of Stay | 1 year | — |
| Hospital Length of Stay | 1 year | — |
| Rate of Intensive Care Unit Admission/Re-admission | 1 year | — |
| Rate of Hospital Admission/Re-admission | 1 year | — |
| Disease-free Survival | 1 year | — |
| Rate of Fungal Infections | 1 year | — |
| Rate of Viral Infections | 1 year | — |
| Rate of Bacterial Infections | 1 year | — |
| Measuring Biomarkers of Inflammation/Frailty in Blood Plasma Samples | 1 year | Biomarker panel to be analyzed: CRP, Eotaxin, Eotaxin-3, FGF (basic), Flt-1/VEGFR-1, GM-CSF, ICAM-1, IFN-γ, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17B, IL-17C, IL-17D, IL-1RA, IL-1α, IL-1β, IL-2, IL-21, IL-22, IL-23, IL-27, IL-3, IL-31, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-9, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, MIP-3α, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, TSLP, VCAM-1, VEGF-A, VEGF-C, VEGF-D |
| Measuring Changes in the Skin Flora (Microbiome) in Transplant Patients | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365 | — |
| Caregiver Support as Assessed by the Caregiver Strain Index Questionnaire | 1 year | Assessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe) |
| Social Support as Assessed by the PROMIS Social Isolation Questionnaire | 1 year | Assessment is scored from 1 (least severe) to 5 (most severe) |
| Diet as Assessed by the Food Group Tracking Digital Application | 30 days | — |
| Diet as Assessed by the TRU-BMT Digital Application | 30 days | — |
| Nutrition as Assessed by the 24 Hour Food Recall Survey | 30 days | — |
| Mental Health as Assessed by PROMIS Depression Questionnaire | 1 year | Assessment is scored from 1 (least severe) to 5 (most severe) |
| Cognitive Function as Assessed by PROMIS Cognitive Questionnaire | 1 year | Assessment is scored from 5 (least severe) to 1 (most severe) |
| Physical Function as Assessed by PROMIS Physical Function Questionnaire | 1 year | Assessment is scored from 5 (least severe) to 1 (most severe) |
| Physical Activity as Measured by Cardiopulmonary Exercise Testing (CPET) | day 180 | CPET is scored by measuring changes in V02 max |
| Rate of Overall Infections | 1 year | — |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Duke Adult Bone Marrow Transplant program between May 2019 and November 2021. The first subject was consented on May 6, 2019 and the last subject was consented on November 2, 2021.
Pre-assignment details
29 subjects (16 patients and 13 caregivers) signed the consent form for this study. 5 subjects (3 patients and 2 caregivers) did not begin the study after signing the consent form. 24 subjects began study activity after signing the consent form.
Participants by arm
| Arm | Count |
|---|---|
| Patient These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Interval training: Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise.
Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up | 13 |
| Caregiver These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up | 11 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Caregiver to patient who died | 0 | 5 |
| Overall Study | Caregiver to patient who was withdrawn due to physician decision | 0 | 1 |
| Overall Study | Death | 5 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Caregiver | Patient |
|---|---|---|---|
| Age, Continuous | 56 Years STANDARD_DEVIATION 12.6 | 55 Years STANDARD_DEVIATION 13.8 | 59 Years STANDARD_DEVIATION 11.6 |
| BMI (body mass index) | 29.5 kg/m2 STANDARD_DEVIATION 4.8 | — | 29.5 kg/m2 STANDARD_DEVIATION 4.8 |
| Diagnosis Acute lymphoblastic leukemia | 1 Participants | — | 1 Participants |
| Diagnosis Acute myeloid leukemia | 3 Participants | — | 3 Participants |
| Diagnosis Chronic lymphocytic leukemia | 1 Participants | — | 1 Participants |
| Diagnosis Diffuse large B-cell lymphoma | 2 Participants | — | 2 Participants |
| Diagnosis Myelodysplastic syndrome | 5 Participants | — | 5 Participants |
| Diagnosis Peripheral T-cell lymphoma | 1 Participants | — | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 11 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Martial Status Married or living with significant other | 23 Participants | 10 Participants | 13 Participants |
| Martial Status Single, never married | 1 Participants | 1 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 | 6 Participants | 3 Participants | 3 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 8 Participants | 10 Participants |
| Receiving chemotherapy during intervention No | 3 Participants | — | 3 Participants |
| Receiving chemotherapy during intervention Yes | 10 Participants | — | 10 Participants |
| Sex: Female, Male Female | 12 Participants | 9 Participants | 3 Participants |
| Sex: Female, Male Male | 12 Participants | 2 Participants | 10 Participants |
| Weight | 90.8 kg STANDARD_DEVIATION 19.7 | — | 90.8 kg STANDARD_DEVIATION 19.7 |
| Work Status Employed Full-Time | 7 Participants | 3 Participants | 4 Participants |
| Work Status Employed Part-Time | 2 Participants | 2 Participants | 0 Participants |
| Work Status Homemaker | 1 Participants | 1 Participants | 0 Participants |
| Work Status Retired | 10 Participants | 4 Participants | 6 Participants |
| Work Status Unemployed/Disabled | 2 Participants | 0 Participants | 2 Participants |
| Work Status Unemployed/Seeking | 1 Participants | 1 Participants | 0 Participants |
| Work Status Unknown/Not Reported | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 13 | 0 / 11 |
| other Total, other adverse events | 2 / 13 | 0 / 11 |
| serious Total, serious adverse events | 0 / 13 | 0 / 11 |
Outcome results
Primary
Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions
Participants were asked to record or report their exercise sessions.
Time frame: 6 months
Population: 13 patients were prescribed the HIIT intervention, but only 9 consistently recorded sessions throughout the duration of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient | Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions | 9 Participants |
Other Pre-specified
Assessing Falls
Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
Time frame: 1 year
Other Pre-specified
Caregiver Quality of Life as Assessed by the Caregiver Strain Questionnaire
Scored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe)
Time frame: 1 year
Other Pre-specified
Caregiver Support as Assessed by the Caregiver Strain Index Questionnaire
Assessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe)
Time frame: 1 year
Other Pre-specified
Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Caregivers
Time frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
Other Pre-specified
Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Transplant Patients
Time frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730
Other Pre-specified
Cognitive Function as Assessed by PROMIS Cognitive Questionnaire
Assessment is scored from 5 (least severe) to 1 (most severe)
Time frame: 1 year
Other Pre-specified
Delirium as Measured by the DOS Assessment
Time frame: 1 year
Other Pre-specified
Diet as Assessed by the Food Group Tracking Digital Application
Time frame: 30 days
Other Pre-specified
Diet as Assessed by the TRU-BMT Digital Application
Time frame: 30 days
Other Pre-specified
Disease-free Survival
Time frame: 1 year
Other Pre-specified
Graft Versus Host Disease (GVHD)
Time frame: 1 year
Other Pre-specified
Hospital Length of Stay
Time frame: 1 year
Other Pre-specified
Intensive Care Unit Length of Stay
Time frame: 1 year
Other Pre-specified
Measuring Biomarkers of Inflammation/Frailty in Blood Plasma Samples
Biomarker panel to be analyzed: CRP, Eotaxin, Eotaxin-3, FGF (basic), Flt-1/VEGFR-1, GM-CSF, ICAM-1, IFN-γ, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17B, IL-17C, IL-17D, IL-1RA, IL-1α, IL-1β, IL-2, IL-21, IL-22, IL-23, IL-27, IL-3, IL-31, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-9, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, MIP-3α, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, TSLP, VCAM-1, VEGF-A, VEGF-C, VEGF-D
Time frame: 1 year
Other Pre-specified
Measuring Changes in the Skin Flora (Microbiome) in Caregivers
Time frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
Other Pre-specified
Measuring Changes in the Skin Flora (Microbiome) in Transplant Patients
Time frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
Other Pre-specified
Mental Health as Assessed by PROMIS Depression Questionnaire
Assessment is scored from 1 (least severe) to 5 (most severe)
Time frame: 1 year
Other Pre-specified
Nutrition as Assessed by the 24 Hour Food Recall Survey
Time frame: 30 days
Other Pre-specified
Overall Survival
Time frame: 1 year
Other Pre-specified
Physical Activity as Measured by Cardiopulmonary Exercise Testing (CPET)
CPET is scored by measuring changes in V02 max
Time frame: day 180
Other Pre-specified
Physical Function as Assessed by PROMIS Physical Function Questionnaire
Assessment is scored from 5 (least severe) to 1 (most severe)
Time frame: 1 year
Other Pre-specified
Quality of Life as Assessed by the FACT-BMT Questionnaire
Scored from 0 (least severe) to 4 (most severe)
Time frame: 1 year
Other Pre-specified
Rate of Bacterial Infections
Time frame: 1 year
Other Pre-specified
Rate of Fungal Infections
Time frame: 1 year
Other Pre-specified
Rate of Hospital Admission/Re-admission
Time frame: 1 year
Other Pre-specified
Rate of Intensive Care Unit Admission/Re-admission
Time frame: 1 year
Other Pre-specified
Rate of Overall Infections
Time frame: 1 year
Other Pre-specified
Rate of Viral Infections
Time frame: 1 year
Other Pre-specified
Return to Work as Assessed by the Work Assessment
Time frame: 1 year
Other Pre-specified
Social Support as Assessed by the PROMIS Social Isolation Questionnaire
Assessment is scored from 1 (least severe) to 5 (most severe)
Time frame: 1 year
Other Pre-specified
Transplant Length of Stay
Time frame: 1 year