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

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03823651
• Other study ID #: Pro00092963
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 27, 2019
• Est. completion date: May 1, 2024

Study information

• Verified date: September 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: May 1, 2024
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms

Intervention

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.
• 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.
• 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
• 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

Locations

Country	Name	City	State
United States	Duke University Adult Bone Marrow Transplant Clinic	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects who complete at least half of their high intensity interval training sessions		6 months
Secondary	Physical activity as measured by Cardiopulmonary exercise testing (CPET)	CPET is scored by measuring changes in V02 max	day 180
Secondary	Physical function as assessed by PROMIS physical function questionnaire	Assessment is scored from 5 (least severe) to 1 (most severe)	1 year
Secondary	Cognitive function as assessed by PROMIS cognitive questionnaire	Assessment is scored from 5 (least severe) to 1 (most severe)	1 year
Secondary	Mental health as assessed by PROMIS depression questionnaire	Assessment is scored from 1 (least severe) to 5 (most severe)	1 year
Secondary	Nutrition as assessed by the 24 hour food recall survey		30 days
Secondary	Diet as assessed by the TRU-BMT digital application		30 days
Secondary	Diet as assessed by the food group tracking digital application		30 days
Secondary	Social support as assessed by the PROMIS social isolation questionnaire	Assessment is scored from 1 (least severe) to 5 (most severe)	1 year
Secondary	Caregiver support as assessed by the caregiver strain index questionnaire	Assessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe)	1 year
Secondary	Measuring Changes in the skin flora (microbiome) in transplant patients		baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
Secondary	Measuring biomarkers of inflammation/frailty in blood plasma samples	Biomarker panel to be analyzed: CRP, Eotaxin, Eotaxin-3, FGF (basic), Flt-1/VEGFR-1, GM-CSF, ICAM-1, IFN-?, 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-1a, IL-1ß, 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-1a, MIP-1ß, MIP-3a, PlGF, SAA, TARC, Tie-2, TNF-a, TNF-ß, TSLP, VCAM-1, VEGF-A, VEGF-C, VEGF-D	1 year
Secondary	Changes in fecal samples as measured by 16s rRNA sequencing in transplant patients		baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730
Secondary	Overall survival		1 year
Secondary	Disease-free survival		1 year
Secondary	Rate of bacterial infections		1 year
Secondary	Rate of viral infections		1 year
Secondary	Rate of fungal infections		1 year
Secondary	Rate of overall infections		1 year
Secondary	Rate of hospital admission/re-admission		1 year
Secondary	Rate of intensive care unit admission/re-admission		1 year
Secondary	Hospital length of stay		1 year
Secondary	Intensive care unit length of stay		1 year
Secondary	Graft versus host disease (GVHD)		1 year
Secondary	Transplant length of stay		1 year
Secondary	Return to work as assessed by the Work Assessment		1 year
Secondary	Assessing falls	Participants will answer Yes/No to whether they have had any falls in the preceding 6 months	1 year
Secondary	Delirium as measured by the DOS assessment		1 year
Secondary	Quality of life as assessed by the FACT-BMT questionnaire	Scored from 0 (least severe) to 4 (most severe)	1 year
Secondary	Caregiver quality of life as assessed by the Caregiver Strain questionnaire	Scored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe)	1 year
Secondary	Changes in fecal samples as measured by 16s rRNA sequencing in caregivers		baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
Secondary	Measuring Changes in the skin flora (microbiome) in caregivers		baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365