A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)

Study Overview
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Brief Summary
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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).

Official Title
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A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Behavioral: Interval training
* Behavioral: Psychiatric consult
* Behavioral: Nutrition/diet evaluation
* Behavioral: Referral to Social Worker


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient<br>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<br>* 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.<br>Behavioral: Psychiatric consult<br>* 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.<br>Behavioral: Nutrition/diet evaluation<br>* 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<br>Behavioral: Referral to Social Worker<br>* 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<br>|
| Experimental: Caregiver<br>These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker. | Behavioral: Psychiatric consult<br>* 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.<br>Behavioral: Nutrition/diet evaluation<br>* 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<br>Behavioral: Referral to Social Worker<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who complete at least half of their high intensity interval training sessions |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity as measured by Cardiopulmonary exercise testing (CPET) | CPET is scored by measuring changes in V02 max | day 180 | 
| Physical function as assessed by PROMIS physical function questionnaire | Assessment is scored from 5 (least severe) to 1 (most severe) | 1 year | 
| Cognitive function as assessed by PROMIS cognitive questionnaire | Assessment is scored from 5 (least severe) to 1 (most severe) | 1 year | 
| Mental health as assessed by PROMIS depression questionnaire | Assessment is scored from 1 (least severe) to 5 (most severe) | 1 year | 
| Nutrition as assessed by the 24 hour food recall survey |  | 30 days | 
| Diet as assessed by the TRU-BMT digital application |  | 30 days | 
| Diet as assessed by the food group tracking digital application |  | 30 days | 
| Social support as assessed by the PROMIS social isolation questionnaire | Assessment is scored from 1 (least severe) to 5 (most severe) | 1 year | 
| 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) | 1 year | 
| Measuring Changes in the skin flora (microbiome) in transplant patients |  | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365 | 
| 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 | 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 | 
| Overall survival |  | 1 year | 
| Disease-free survival |  | 1 year | 
| Rate of bacterial infections |  | 1 year | 
| Rate of viral infections |  | 1 year | 
| Rate of fungal infections |  | 1 year | 
| Rate of overall infections |  | 1 year | 
| Rate of hospital admission/re-admission |  | 1 year | 
| Rate of intensive care unit admission/re-admission |  | 1 year | 
| Hospital length of stay |  | 1 year | 
| Intensive care unit length of stay |  | 1 year | 
| Graft versus host disease (GVHD) |  | 1 year | 
| Transplant length of stay |  | 1 year | 
| Return to work as assessed by the Work Assessment |  | 1 year | 
| Assessing falls | Participants will answer Yes/No to whether they have had any falls in the preceding 6 months | 1 year | 
| Delirium as measured by the DOS assessment |  | 1 year | 
| Quality of life as assessed by the FACT-BMT questionnaire | Scored from 0 (least severe) to 4 (most severe) | 1 year | 
| 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) | 1 year | 
| 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 | 
| Measuring Changes in the skin flora (microbiome) in caregivers |  | baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365 |