An interventional study of Interval training and Psychiatric consult in Hematologic Malignancy, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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).
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 29 is below the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver inclusion criteria
Caregiver exclusion criteria
These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Behavioral: Interval training · Behavioral: Psychiatric consult · Behavioral: Nutrition/diet evaluation · Behavioral: Referral to Social Worker
These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Behavioral: Psychiatric consult · Behavioral: Nutrition/diet evaluation · Behavioral: Referral to Social Worker
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.
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.
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
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
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
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
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
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
Quality of Life as Assessed by the FACT-BMT Questionnaire
Scored from 0 (least severe) to 4 (most severe)
Time frame: 1 year
Delirium as Measured by the DOS Assessment
Time frame: 1 year
Assessing Falls
Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
Time frame: 1 year
Return to Work as Assessed by the Work Assessment
Time frame: 1 year
Transplant Length of Stay
Time frame: 1 year
Graft Versus Host Disease (GVHD)
Time frame: 1 year
Intensive Care Unit Length of Stay
Time frame: 1 year
Hospital Length of Stay
Time frame: 1 year
Rate of Intensive Care Unit Admission/Re-admission
Time frame: 1 year
Rate of Hospital Admission/Re-admission
Time frame: 1 year
Rate of Overall Infections
Time frame: 1 year
Rate of Fungal Infections
Time frame: 1 year
Rate of Viral Infections
Time frame: 1 year
Rate of Bacterial Infections
Time frame: 1 year
Disease-free Survival
Time frame: 1 year
Overall Survival
Time frame: 1 year
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
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
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
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
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
Diet as Assessed by the Food Group Tracking Digital Application
Time frame: 30 days
Diet as Assessed by the TRU-BMT Digital Application
Time frame: 30 days
Nutrition as Assessed by the 24 Hour Food Recall Survey
Time frame: 30 days
Mental Health as Assessed by PROMIS Depression Questionnaire
Assessment is scored from 1 (least severe) to 5 (most severe)
Time frame: 1 year
Cognitive Function as Assessed by PROMIS Cognitive Questionnaire
Assessment is scored from 5 (least severe) to 1 (most severe)
Time frame: 1 year
Physical Function as Assessed by PROMIS Physical Function Questionnaire
Assessment is scored from 5 (least severe) to 1 (most severe)
Time frame: 1 year
Physical Activity as Measured by Cardiopulmonary Exercise Testing (CPET)
CPET is scored by measuring changes in V02 max
Time frame: day 180
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.
| Milestone | Patient | Caregiver |
|---|---|---|
| Started | 13 | 11 |
| Completed | 7 | 5 |
| Not completed | 6 | 6 |
| Withdrew: Death | 5 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Caregiver to patient who died | 0 | 5 |
| Withdrew: Caregiver to patient who was withdrawn due to physician decision | 0 | 1 |
Participants were asked to record or report their exercise sessions.
| Participants | Patient |
|---|---|
| Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions | 9 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Scored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe)
Results for this outcome have not been posted.
Scored from 0 (least severe) to 4 (most severe)
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Assessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe)
Results for this outcome have not been posted.
Assessment is scored from 1 (least severe) to 5 (most severe)
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Assessment is scored from 1 (least severe) to 5 (most severe)
Results for this outcome have not been posted.
Assessment is scored from 5 (least severe) to 1 (most severe)
Results for this outcome have not been posted.
Assessment is scored from 5 (least severe) to 1 (most severe)
Results for this outcome have not been posted.
CPET is scored by measuring changes in V02 max
Results for this outcome have not been posted.
Collected over Adverse event data was collected for participants from enrollment through 1 year post-transplant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient | 5/13 (38.5%) | 0/13 (0%) | 2/13 (15.4%) |
| Caregiver | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Event | Patient | Caregiver |
|---|---|---|
| Cardiac ArrhythmiaCardiac disorders | 1/13 | 0/11 |
| Hip FractureInjury, poisoning and procedural complications | 1/13 | 0/11 |
| Surgery for hip fractureSurgical and medical procedures | 1/13 | 0/11 |
| Age, Continuous(Years) | Patient | Caregiver | Total |
|---|---|---|---|
| Mean | 59 ± 11.6 | 55 ± 13.8 | 56 ± 12.6 |
| Sex: Female, Male(Participants) | Patient | Caregiver | Total |
|---|---|---|---|
| Female | 3 | 9 | 12 |
| Male | 10 | 2 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Patient | Caregiver | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 13 | 11 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Patient | Caregiver | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 10 | 8 | 18 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| BMI (body mass index)(kg/m2) | Patient | Caregiver | Total |
|---|---|---|---|
| Mean | 29.5 ± 4.8 | — | 29.5 ± 4.8 |
| Weight(kg) | Patient | Caregiver | Total |
|---|---|---|---|
| Mean | 90.8 ± 19.7 | — | 90.8 ± 19.7 |
| Diagnosis(Participants) | Patient | Caregiver | Total |
|---|---|---|---|
| Myelodysplastic syndrome | 5 | — | 5 |
| Acute myeloid leukemia | 3 | — | 3 |
| Diffuse large B-cell lymphoma | 2 | — | 2 |
| Acute lymphoblastic leukemia | 1 | — | 1 |
| Chronic lymphocytic leukemia | 1 | — | 1 |
| Peripheral T-cell lymphoma | 1 | — | 1 |
| Receiving chemotherapy during intervention(Participants) | Patient | Caregiver | Total |
|---|---|---|---|
| Yes | 10 | — | 10 |
| No | 3 | — | 3 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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