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

Primary Purpose

Hematologic Malignancy

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interval training
Psychiatric consult
Nutrition/diet evaluation
Referral to Social Worker
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Adult Bone Marrow Transplant Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient

Caregiver

Arm Description

These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and 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.

Outcomes

Primary Outcome Measures

Number of subjects who complete at least half of their high intensity interval training sessions

Secondary Outcome Measures

Physical activity as measured by Cardiopulmonary exercise testing (CPET)
CPET is scored by measuring changes in V02 max
Physical function as assessed by PROMIS physical function questionnaire
Assessment is scored from 5 (least severe) to 1 (most severe)
Cognitive function as assessed by PROMIS cognitive questionnaire
Assessment is scored from 5 (least severe) to 1 (most severe)
Mental health as assessed by PROMIS depression questionnaire
Assessment is scored from 1 (least severe) to 5 (most severe)
Nutrition as assessed by the 24 hour food recall survey
Diet as assessed by the TRU-BMT digital application
Diet as assessed by the food group tracking digital application
Social support as assessed by the PROMIS social isolation questionnaire
Assessment is scored from 1 (least severe) to 5 (most severe)
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)
Measuring Changes in the skin flora (microbiome) in transplant patients
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
Changes in fecal samples as measured by 16s rRNA sequencing in transplant patients
Overall survival
Disease-free survival
Rate of bacterial infections
Rate of viral infections
Rate of fungal infections
Rate of overall infections
Rate of hospital admission/re-admission
Rate of intensive care unit admission/re-admission
Hospital length of stay
Intensive care unit length of stay
Graft versus host disease (GVHD)
Transplant length of stay
Return to work as assessed by the Work Assessment
Assessing falls
Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
Delirium as measured by the DOS assessment
Quality of life as assessed by the FACT-BMT questionnaire
Scored from 0 (least severe) to 4 (most severe)
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)
Changes in fecal samples as measured by 16s rRNA sequencing in caregivers
Measuring Changes in the skin flora (microbiome) in caregivers

Full Information

First Posted
January 28, 2019
Last Updated
December 16, 2022
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03823651
Brief Title
A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)
Official Title
A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
October 27, 2022 (Actual)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Experimental
Arm Description
These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Arm Title
Caregiver
Arm Type
Experimental
Arm Description
These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Intervention Type
Behavioral
Intervention Name(s)
Interval training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychiatric consult
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition/diet evaluation
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Referral to Social Worker
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of subjects who complete at least half of their high intensity interval training sessions
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Physical activity as measured by Cardiopulmonary exercise testing (CPET)
Description
CPET is scored by measuring changes in V02 max
Time Frame
day 180
Title
Physical function as assessed by PROMIS physical function questionnaire
Description
Assessment is scored from 5 (least severe) to 1 (most severe)
Time Frame
1 year
Title
Cognitive function as assessed by PROMIS cognitive questionnaire
Description
Assessment is scored from 5 (least severe) to 1 (most severe)
Time Frame
1 year
Title
Mental health as assessed by PROMIS depression questionnaire
Description
Assessment is scored from 1 (least severe) to 5 (most severe)
Time Frame
1 year
Title
Nutrition as assessed by the 24 hour food recall survey
Time Frame
30 days
Title
Diet as assessed by the TRU-BMT digital application
Time Frame
30 days
Title
Diet as assessed by the food group tracking digital application
Time Frame
30 days
Title
Social support as assessed by the PROMIS social isolation questionnaire
Description
Assessment is scored from 1 (least severe) to 5 (most severe)
Time Frame
1 year
Title
Caregiver support as assessed by the caregiver strain index questionnaire
Description
Assessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe)
Time Frame
1 year
Title
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
Title
Measuring biomarkers of inflammation/frailty in blood plasma samples
Description
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
Title
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
Title
Overall survival
Time Frame
1 year
Title
Disease-free survival
Time Frame
1 year
Title
Rate of bacterial infections
Time Frame
1 year
Title
Rate of viral infections
Time Frame
1 year
Title
Rate of fungal infections
Time Frame
1 year
Title
Rate of overall infections
Time Frame
1 year
Title
Rate of hospital admission/re-admission
Time Frame
1 year
Title
Rate of intensive care unit admission/re-admission
Time Frame
1 year
Title
Hospital length of stay
Time Frame
1 year
Title
Intensive care unit length of stay
Time Frame
1 year
Title
Graft versus host disease (GVHD)
Time Frame
1 year
Title
Transplant length of stay
Time Frame
1 year
Title
Return to work as assessed by the Work Assessment
Time Frame
1 year
Title
Assessing falls
Description
Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
Time Frame
1 year
Title
Delirium as measured by the DOS assessment
Time Frame
1 year
Title
Quality of life as assessed by the FACT-BMT questionnaire
Description
Scored from 0 (least severe) to 4 (most severe)
Time Frame
1 year
Title
Caregiver quality of life as assessed by the Caregiver Strain questionnaire
Description
Scored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe)
Time Frame
1 year
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 exclusion criteria None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Sung, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Adult Bone Marrow Transplant Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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