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

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).

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Behavioral: Interval training; Behavioral: Psychiatric consult; Behavioral: Nutrition/diet evaluation; Behavioral: Referral to Social Worker

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Adult Bone Marrow Transplant Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Behavioral: 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.; Behavioral: 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; Behavioral: 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
Experimental: Caregiver; These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.	Behavioral: 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.; Behavioral: 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; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		1 year
Disease-free survival		1 year
Hospital length of stay		1 year
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival		1 year
Disease-free Survival		1 year
Transplant Length of Stay		1 year
Hospital Length of Stay		1 year
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	Scored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe)	1 year
Quality of Life as Assessed by the FACT-BMT Questionnaire	Scored from 0 (least severe) to 4 (most severe)	1 year
Delirium as Measured by the DOS Assessment		1 year
Assessing Falls	Participants will answer Yes/No to whether they have had any falls in the preceding 6 months	1 year
Return to Work as Assessed by the Work Assessment		1 year
Graft Versus Host Disease (GVHD)		1 year
Intensive Care Unit Length of Stay		1 year
Rate of Intensive Care Unit Admission/Re-admission		1 year
Rate of Hospital Admission/Re-admission		1 year
Rate of Overall Infections		1 year
Rate of Fungal Infections		1 year
Rate of Viral Infections		1 year
Rate of Bacterial Infections		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 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
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	Assessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe)	1 year
Social Support as Assessed by the PROMIS Social Isolation Questionnaire	Assessment is scored from 1 (least severe) to 5 (most severe)	1 year
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	Assessment is scored from 1 (least severe) to 5 (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
Physical Function as Assessed by PROMIS Physical Function Questionnaire	Assessment is scored from 5 (least severe) to 1 (most severe)	1 year
Physical Activity as Measured by Cardiopulmonary Exercise Testing (CPET)	CPET is scored by measuring changes in V02 max	day 180

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Anthony Sung, MD, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Actual): October 27, 2022
• Study Completion (Actual): April 27, 2024

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: Pro00092963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No