Clinical trial NCT03823651: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Measuring Changes in the Skin Flora (Microbiome) in Caregivers
timeFrame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
measure: Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Caregivers
timeFrame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
measure: Caregiver Quality of Life as Assessed by the Caregiver Strain Questionnaire
timeFrame: 1 year
measure: Quality of Life as Assessed by the FACT-BMT Questionnaire
timeFrame: 1 year
measure: Delirium as Measured by the DOS Assessment
timeFrame: 1 year
measure: Assessing Falls
timeFrame: 1 year
measure: Return to Work as Assessed by the Work Assessment
timeFrame: 1 year
measure: Transplant Length of Stay
timeFrame: 1 year
measure: Graft Versus Host Disease (GVHD)
timeFrame: 1 year
measure: Intensive Care Unit Length of Stay
timeFrame: 1 year
measure: Hospital Length of Stay
timeFrame: 1 year
measure: Rate of Intensive Care Unit Admission/Re-admission
timeFrame: 1 year
measure: Rate of Hospital Admission/Re-admission
timeFrame: 1 year
measure: Rate of Overall Infections
timeFrame: 1 year
measure: Rate of Fungal Infections
timeFrame: 1 year
measure: Rate of Viral Infections
timeFrame: 1 year
measure: Rate of Bacterial Infections
timeFrame: 1 year
measure: Disease-free Survival
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
measure: Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Transplant Patients
timeFrame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730
measure: Measuring Biomarkers of Inflammation/Frailty in Blood Plasma Samples
timeFrame: 1 year
measure: Measuring Changes in the Skin Flora (Microbiome) in Transplant Patients
timeFrame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
measure: Caregiver Support as Assessed by the Caregiver Strain Index Questionnaire
timeFrame: 1 year
measure: Social Support as Assessed by the PROMIS Social Isolation Questionnaire
timeFrame: 1 year
measure: Diet as Assessed by the Food Group Tracking Digital Application
timeFrame: 30 days
measure: Diet as Assessed by the TRU-BMT Digital Application
timeFrame: 30 days
measure: Nutrition as Assessed by the 24 Hour Food Recall Survey
timeFrame: 30 days
measure: Mental Health as Assessed by PROMIS Depression Questionnaire
timeFrame: 1 year
measure: Cognitive Function as Assessed by PROMIS Cognitive Questionnaire
timeFrame: 1 year
measure: Physical Function as Assessed by PROMIS Physical Function Questionnaire
timeFrame: 1 year
measure: Physical Activity as Measured by Cardiopulmonary Exercise Testing (CPET)
timeFrame: day 180
Locations:
city: Durham
country: United States
facility: Duke University Adult Bone Marrow Transplant Clinic
state: North Carolina
Study officials:
affiliation: Duke Health
name: Anthony Sung, MD
role: PRINCIPAL_INVESTIGATOR
References: