Duke University Adult Bone Marrow Transplant Clinic
Durham, North Carolina, 27705, United States
NCT Number: NCT03823651
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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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Durham, North Carolina, 27705, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver inclusion criteria
Caregiver exclusion criteria
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.
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.
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
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
Time frame: 6 months
Participants were asked to record or report their exercise sessions.
Time frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
Time frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
Time frame: 1 year
Scored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe)
Time frame: 1 year
Scored from 0 (least severe) to 4 (most severe)
Time frame: 1 year
Time frame: 1 year
Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Time frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730
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
Time frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
Time frame: 1 year
Assessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe)
Time frame: 1 year
Assessment is scored from 1 (least severe) to 5 (most severe)
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 1 year
Assessment is scored from 1 (least severe) to 5 (most severe)
Time frame: 1 year
Assessment is scored from 5 (least severe) to 1 (most severe)
Time frame: 1 year
Assessment is scored from 5 (least severe) to 1 (most severe)
Time frame: day 180
CPET is scored by measuring changes in V02 max
Duke University
Other
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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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