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

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ClinicalTrials.gov Identifier: NCT03823651
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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).

Condition or disease Intervention/treatment Phase
Hematologic Malignancy Behavioral: Interval training Behavioral: Psychiatric consult Behavioral: Nutrition/diet evaluation Behavioral: Referral to Social Worker Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

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




Primary Outcome Measures :
  1. Number of subjects who complete at least half of their high intensity interval training sessions [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Physical activity as measured by Cardiopulmonary exercise testing (CPET) [ Time Frame: day 180 ]
    CPET is scored by measuring changes in V02 max

  2. Physical function as assessed by PROMIS physical function questionnaire [ Time Frame: 1 year ]
    Assessment is scored from 5 (least severe) to 1 (most severe)

  3. Cognitive function as assessed by PROMIS cognitive questionnaire [ Time Frame: 1 year ]
    Assessment is scored from 5 (least severe) to 1 (most severe)

  4. Mental health as assessed by PROMIS depression questionnaire [ Time Frame: 1 year ]
    Assessment is scored from 1 (least severe) to 5 (most severe)

  5. Nutrition as assessed by the 24 hour food recall survey [ Time Frame: 30 days ]
  6. Diet as assessed by the TRU-BMT digital application [ Time Frame: 30 days ]
  7. Diet as assessed by the food group tracking digital application [ Time Frame: 30 days ]
  8. 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)

  9. 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)

  10. 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 ]
  11. 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

  12. 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 ]
  13. Overall survival [ Time Frame: 1 year ]
  14. Disease-free survival [ Time Frame: 1 year ]
  15. Rate of bacterial infections [ Time Frame: 1 year ]
  16. Rate of viral infections [ Time Frame: 1 year ]
  17. Rate of fungal infections [ Time Frame: 1 year ]
  18. Rate of overall infections [ Time Frame: 1 year ]
  19. Rate of hospital admission/re-admission [ Time Frame: 1 year ]
  20. Rate of intensive care unit admission/re-admission [ Time Frame: 1 year ]
  21. Hospital length of stay [ Time Frame: 1 year ]
  22. Intensive care unit length of stay [ Time Frame: 1 year ]
  23. Graft versus host disease (GVHD) [ Time Frame: 1 year ]
  24. Transplant length of stay [ Time Frame: 1 year ]
  25. Return to work as assessed by the Work Assessment [ Time Frame: 1 year ]
  26. Assessing falls [ Time Frame: 1 year ]
    Participants will answer Yes/No to whether they have had any falls in the preceding 6 months

  27. Delirium as measured by the DOS assessment [ Time Frame: 1 year ]
  28. Quality of life as assessed by the FACT-BMT questionnaire [ Time Frame: 1 year ]
    Scored from 0 (least severe) to 4 (most severe)

  29. 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)

  30. 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 ]
  31. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823651


Locations
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United States, North Carolina
Duke University Adult Bone Marrow Transplant Clinic Recruiting
Durham, North Carolina, United States, 27705
Contact: Krista Rowe-Nichols, RN    919-684-7115    krista.rowe@duke.edu   
Contact: Jennifer Loftis, RN    919-668-1939    jennifer.loftis@duke.edu   
Principal Investigator: Anthony Sung, MD         
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03823651     History of Changes
Other Study ID Numbers: Pro00092963
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No