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Completed

NCT Number: NCT03823651

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Adult Bone Marrow Transplant Clinic

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interval Training

Behavioral

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.

Psychiatric consult

Behavioral

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.

Nutrition/diet evaluation

Behavioral

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

Referral to Social Worker

Behavioral

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 outcomes

  1. 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.

Other outcomes

  1. 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

  2. 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

  3. 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)

  4. Quality of Life as Assessed by the FACT-BMT Questionnaire

    Time frame: 1 year

    Scored from 0 (least severe) to 4 (most severe)

  5. Delirium as Measured by the DOS Assessment

    Time frame: 1 year

  6. Assessing Falls

    Time frame: 1 year

    Participants will answer Yes/No to whether they have had any falls in the preceding 6 months

  7. Return to Work as Assessed by the Work Assessment

    Time frame: 1 year

  8. Transplant Length of Stay

    Time frame: 1 year

  9. Graft Versus Host Disease (GVHD)

    Time frame: 1 year

  10. Intensive Care Unit Length of Stay

    Time frame: 1 year

  11. Hospital Length of Stay

    Time frame: 1 year

  12. Rate of Intensive Care Unit Admission/Re-admission

    Time frame: 1 year

  13. Rate of Hospital Admission/Re-admission

    Time frame: 1 year

  14. Rate of Overall Infections

    Time frame: 1 year

  15. Rate of Fungal Infections

    Time frame: 1 year

  16. Rate of Viral Infections

    Time frame: 1 year

  17. Rate of Bacterial Infections

    Time frame: 1 year

  18. Disease-free Survival

    Time frame: 1 year

  19. Overall Survival

    Time frame: 1 year

  20. 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

  21. 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

  22. 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

  23. 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)

  24. 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)

  25. Diet as Assessed by the Food Group Tracking Digital Application

    Time frame: 30 days

  26. Diet as Assessed by the TRU-BMT Digital Application

    Time frame: 30 days

  27. Nutrition as Assessed by the 24 Hour Food Recall Survey

    Time frame: 30 days

  28. Mental Health as Assessed by PROMIS Depression Questionnaire

    Time frame: 1 year

    Assessment is scored from 1 (least severe) to 5 (most severe)

  29. Cognitive Function as Assessed by PROMIS Cognitive Questionnaire

    Time frame: 1 year

    Assessment is scored from 5 (least severe) to 1 (most severe)

  30. Physical Function as Assessed by PROMIS Physical Function Questionnaire

    Time frame: 1 year

    Assessment is scored from 5 (least severe) to 1 (most severe)

  31. Physical Activity as Measured by Cardiopulmonary Exercise Testing (CPET)

    Time frame: day 180

    CPET is scored by measuring changes in V02 max

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2024
First posted
Jan 30, 2019
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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