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

September 17, 2024 updated by: Duke University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions
Time Frame: 6 months
Participants were asked to record or report their exercise sessions.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
1 year
Disease-free survival
Time Frame: 1 year
1 year
Hospital length of stay
Time Frame: 1 year
1 year
Physical activity as measured by Cardiopulmonary exercise testing (CPET)
Time Frame: day 180
CPET is scored by measuring changes in V02 max
day 180
Physical function as assessed by PROMIS physical function questionnaire
Time Frame: 1 year
Assessment is scored from 5 (least severe) to 1 (most severe)
1 year
Cognitive function as assessed by PROMIS cognitive questionnaire
Time Frame: 1 year
Assessment is scored from 5 (least severe) to 1 (most severe)
1 year
Mental health as assessed by PROMIS depression questionnaire
Time Frame: 1 year
Assessment is scored from 1 (least severe) to 5 (most severe)
1 year
Nutrition as assessed by the 24 hour food recall survey
Time Frame: 30 days
30 days
Diet as assessed by the TRU-BMT digital application
Time Frame: 30 days
30 days
Diet as assessed by the food group tracking digital application
Time Frame: 30 days
30 days
Social support as assessed by the PROMIS social isolation questionnaire
Time Frame: 1 year
Assessment is scored from 1 (least severe) to 5 (most severe)
1 year
Caregiver support as assessed by the caregiver strain index questionnaire
Time Frame: 1 year
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
Time Frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
Measuring biomarkers of inflammation/frailty in blood plasma samples
Time Frame: 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
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
baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730
Rate of bacterial infections
Time Frame: 1 year
1 year
Rate of viral infections
Time Frame: 1 year
1 year
Rate of fungal infections
Time Frame: 1 year
1 year
Rate of overall infections
Time Frame: 1 year
1 year
Rate of hospital admission/re-admission
Time Frame: 1 year
1 year
Rate of intensive care unit admission/re-admission
Time Frame: 1 year
1 year
Intensive care unit length of stay
Time Frame: 1 year
1 year
Graft versus host disease (GVHD)
Time Frame: 1 year
1 year
Transplant length of stay
Time Frame: 1 year
1 year
Return to work as assessed by the Work Assessment
Time Frame: 1 year
1 year
Assessing falls
Time Frame: 1 year
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
Time Frame: 1 year
1 year
Quality of life as assessed by the FACT-BMT questionnaire
Time Frame: 1 year
Scored from 0 (least severe) to 4 (most severe)
1 year
Caregiver quality of life as assessed by the Caregiver Strain questionnaire
Time Frame: 1 year
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
Time Frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
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
baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 1 year
1 year
Disease-free Survival
Time Frame: 1 year
1 year
Transplant Length of Stay
Time Frame: 1 year
1 year
Hospital Length of Stay
Time Frame: 1 year
1 year
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
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
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
Time Frame: 1 year
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
Time Frame: 1 year
Scored from 0 (least severe) to 4 (most severe)
1 year
Delirium as Measured by the DOS Assessment
Time Frame: 1 year
1 year
Assessing Falls
Time Frame: 1 year
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
Time Frame: 1 year
1 year
Graft Versus Host Disease (GVHD)
Time Frame: 1 year
1 year
Intensive Care Unit Length of Stay
Time Frame: 1 year
1 year
Rate of Intensive Care Unit Admission/Re-admission
Time Frame: 1 year
1 year
Rate of Hospital Admission/Re-admission
Time Frame: 1 year
1 year
Rate of Overall Infections
Time Frame: 1 year
1 year
Rate of Fungal Infections
Time Frame: 1 year
1 year
Rate of Viral Infections
Time Frame: 1 year
1 year
Rate of Bacterial Infections
Time Frame: 1 year
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
baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730
Measuring Biomarkers of Inflammation/Frailty in Blood Plasma Samples
Time Frame: 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
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
baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
Caregiver Support as Assessed by the Caregiver Strain Index Questionnaire
Time Frame: 1 year
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
Time Frame: 1 year
Assessment is scored from 1 (least severe) to 5 (most severe)
1 year
Diet as Assessed by the Food Group Tracking Digital Application
Time Frame: 30 days
30 days
Diet as Assessed by the TRU-BMT Digital Application
Time Frame: 30 days
30 days
Nutrition as Assessed by the 24 Hour Food Recall Survey
Time Frame: 30 days
30 days
Mental Health as Assessed by PROMIS Depression Questionnaire
Time Frame: 1 year
Assessment is scored from 1 (least severe) to 5 (most severe)
1 year
Cognitive Function as Assessed by PROMIS Cognitive Questionnaire
Time Frame: 1 year
Assessment is scored from 5 (least severe) to 1 (most severe)
1 year
Physical Function as Assessed by PROMIS Physical Function Questionnaire
Time Frame: 1 year
Assessment is scored from 5 (least severe) to 1 (most severe)
1 year
Physical Activity as Measured by Cardiopulmonary Exercise Testing (CPET)
Time Frame: day 180
CPET is scored by measuring changes in V02 max
day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anthony Sung, MD, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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