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Survivorship Post-HCT Optimization Program (S-POP)

Primary Purpose

Hematologic Malignancy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematologic Malignancy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patient Inclusion Criteria:

  1. ≥18 years old
  2. English speaking
  3. Within 90 ± 30 days post allogenic HCT

Caregiver Inclusion Criteria:

  1. ≥18 years old
  2. English speaking
  3. Providing post-discharge care for the patient who has undergone HCT

Patient and Caregiver Exclusion Criteria:

  1. Have an absolute contraindication to exercise including a recent acute cardiac event (<6 months), unstable angina, uncontrolled dysthymias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspects or known dissecting aneurism, or coronary artery disease.
  2. In addition to these absolute contraindications, the patient and caregiver will complete cardiopulmonary exercise testing (CPET) where the heart rate and heart rhythm will be monitored via a 12-lead ECG before, during, and after the test. The results from the CPET will be reviewed by a physician before the subject is cleared to participate in the HIIT and resistance training program. If the participant is not cleared by the physician following the CPET, then the patient and his or her caregiver will not be eligible to participate in the study.

Sites / Locations

  • Duke Adult Blood and Marrow Transplant ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient

Caregiver

Arm Description

These are patients who are 90 (±30) days post-allogeneic hematopoietic stem cell transplant. Patients will complete 12 weeks of exercise training. Patients will also complete assessments to evaluate physical function, cognitive function, mental health, social support, nutrition and diet, symptoms, quality of life, and financial status. They will use devices to capture activity data and vital signs. They will collect bio-specimens to assess microbiota and biomarkers.

These are the assigned caregivers for the transplant patients. Caregivers will complete 12 weeks of exercise training. Caregivers will also complete assessments to evaluate physical function, caregiver support, and physical activity and exercise. They will collect bio-specimens to assess microbiota.

Outcomes

Primary Outcome Measures

Adherence to prescribed exercise program, as measured by number of total sessions completed
Compliance to prescribed HIIT sessions, as measured by total session time (in minutes)
Compliance to prescribed HIIT sessions, as measured by number of intervals completed
Compliance to prescribed HIIT sessions, as measured by number/percentage of intervals meeting target heart rates
Compliance to prescribed resistance sessions, as measured by number of sets completed
Compliance to prescribed resistance sessions, as measured by number of repetitions completed

Secondary Outcome Measures

Change in physical function/activity, as measured by SPPB
All the task points are added which make the SPPB score. The cut-point for the SPPB is a score of 10. The cumulative and sections scores are assessed individually and comprehensively. This assessment score will be used as a tool for evaluating lower extremity functioning in older persons.
Change in physical function/activity, as measured by 6-minute walk test
The baseline for each patient is made through an algorithm that factors the patients age and gender. The patient's score is compared to what a person that is the patient's same age and gender would get. This comparison is then used as a tool to assess aerobic capacity or endurance.
Change in physical function/activity, as measured by 30-second sit-to-stand
Subjects will sit in a chair with their arms crossed over their chest and rise to a standing position, then return to seated position. They will repeat this as many times as they can in 30 seconds.
Change in physical function/activity, as measured by grip strength
The hand grip is an indicator of upper body strength and has been found to be a good predictor of future functional limitations and disabilities. The hand grip score is determined based on how quickly the participant can squeeze the hand dynamometer.
Change in physical function/activity, as measured by Fried Frailty
The scores of all of the sections are added and if the patient has a score greater or equal to three this assessment deems that the patients is frail. If the patient has a score between 1-2 the patient is deemed pre-frail.
Change in physical function/activity, as measured by PROMIS Physical Function
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Change in physical function/activity, as measured by bioelectrical impedance (BIA)
Participants will have body composition assessed by bioelectrical impedance spectroscopy (BIS) via a bioimpedance analysis (BIA) device. BIA equipment does not measure muscle mass directly, but instead derives an estimate of muscle mass based on whole-body electrical conductivity.
Change in physical function/activity, as measured by CPET
Exercise capacity will be assessed using a symptom-limited Cardiopulmonary Exercise Test (CPET) on a cycle ergometer or for a six-minute step test with expired gas analysis to determine VO2peak, according to guidelines for clinical populations (Jones et al., 2012). All CPET data will be recorded as the highest 30-second value elicited during the CPET.
Change in physical function/activity, as measured by Intramuscular Adipose Tissue (IMAT)
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus. Complex grayscale analysis of the images is used to calculate the IMAT.
Change in physical function/activity, as measured by Intramuscular Glycogen Content (IMGC)
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus. Complex grayscale analysis of the images is used to calculate the IMGC.
Change in physical function/activity, as measured by muscle thickness
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus, using greyscale analyses.
Change in physical function/activity, as measured by muscle area
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus, using greyscale analyses.
Change in physical function/activity, as measured by subcutaneous fat layer thickness
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus, using greyscale analyses.
Change in cognitive function, as measured by Montreal Cognitive Assessment (MOCA)
This administered assessment is subdivided into visuospatial/executive (5pts), naming (3pts), memory (no points), attention(5pts), language(3pts), abstraction(2pts), delayed recall(5pts), and orientation(6pts). All the subdivided sections have as many questions as they have points. For analysis, the cut point is if the patient has less than 26 points.
Change in cognitive function, as measured by PROMIS Cognitive Function
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Change in cognitive function, as measured by RBANS
RBANS evaluation produces five index scores as well as a total summary score, and total scaled score. Scores range from 40 to 160, with higher scores indicating better performance (Smith et al., 2014). The scaled score classifies neuropsychological performance as: extremely low (69 and below), borderline (70-79), low average (80-89), average (90-109), high average (110-119), superior (120-129), and very superior (130 and above) (Batty et al., 2016; Randolph et al., 1998).
Change in cognitive function, as measured by Trail making test
Trail Making Test parts A and B (TMT-A and -B) will be used for identification of cognitively impairment. Total time to completion will be used as outcome variable for both parts (ranging from 0 to 300 seconds, with higher scores indicating worse performance (Smith et al., 2014). An adjusted mean T-score also will be calculated ranging from 0 to 100 (mean score 50, higher score indicating better performance). The T-score can be adjusted for age, sex, education and ethnicity.
Change in cognitive function, as measured by Brief Cope
Scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style.
Change in mental health, as measured by PHQ-9
The PHQ-9 consists of 9 items, each of which is scored 0 to 3, giving a 0 to 27 severity score
Change in mental health, as measured by PC-PTSD/PCL-5
PC-PTSD is a 5 item screen to identify patients with probable PTSD. If the patient screens positive, they then take the PCL-5. The PCL-5 is a 20 item screen to assess symptoms of PTSD.
Change in mental health, as measured by PROMIS Depression
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Change in mental health, as measured by PROMIS Anxiety
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Change in diet/nutrition, as measured by Perioperative Nutrition Screen (PONS)
PONS analyzes BMI, weight loss, and food intake to screen for preoperative nutrition risk
Change in diet/nutrition, as measured by PG-SGA/Clinician SGA
Scores for each section can range from 0-4 depending on severity and nutritional impact. The sum of all scores provides the Total PG-SGA score, which can be used to indicate the need for intervention (Bauer et al., 2002)
Change in diet/nutrition, as measured by ASA-24
ASA-24 is a self-administered 24-hour diet recall
Change in diet/nutrition, as measured by Food Security
Participants will be given the USDA food security survey to review their food securities or insecurities. This is a 10 item survey.
Change in social support, as measured by PROMIS Emotional Support
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Change in social support, as measured by PROMIS Social Isolation
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Change in social support, as measured by Lorig Self Efficacy
The Self-Efficacy to Manage Chronic Disease Scale is made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident).
Change in social support, as measured by CFC-14
CFC-14 is a 14 item questionnaire to assess a patient's consideration of immediate and consideration of future consequences
Change in social support, as measured by Brief Resilience Scale
BRS assesses the patient's ability to recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience).
Change in caregiver support, as measured by Caregiver Strain index
Tool to assess strain on long-term caregivers
Change in caregiver support, as measured by Preparedness for Caregiving assessment
Items are scored by calculating the mean of all items with a range of 0-4. The higher the score, the more prepared the caregiver feels to give care.
Change in caregiver support, as measured by FACT-GP
21 item assessment scored on a 5-point Likert scale
Change in caregiver support, as measured by PHQ-2
The PHQ-9 consists of 2 items, each of which is scored 0 to 3, giving a 0 to 6 severity score
Change in caregiver support, as measured by PCL-5
The PCL-5 is a 20 item screen to assess symptoms of PTSD.
Change in caregiver support, as measured by Ego Resiliency
14 item survey scored from 0-56, where a higher score indicates higher level of resiliency
Change in caregiver support, as measured by PROMIS Depression
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Change in caregiver support, as measured by PROMIS Anxiety
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Change in caregiver support, as measured by PROMIS Emotional Support
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Change in caregiver support, as measured by PROMIS Social Isolation
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Change in microbiota diversity, as measured by skin swabs
Skin swab samples batch sequenced and microbiome analyzed
Change in microbiota diversity, as measured by stool samples
Changes in stool samples as measured by 16s rRNA sequencing
Change in biomarkers of inflammation and frailty, as measured by blood plasma samples
Assays evaluating angiogenic, stromal, and inflammatory markers and markers of aging (the Pepper Panel) are used to assess inflammation and frailty
Overall survival, as measured by medical record review
Disease-free survival, as measured by medical record review
Rate of bacterial infection, as measured by medical record review
Rate of fungal infection, as measured by medical record review
Rate of viral infection, as measured by medical record review
Rate of overall infection, as measured by medical record review
Rate of hospital admission, as measured by medical record review
Rate of intensive care unit admission, as measured by medical record review
Hospital length of stay, as measured by medical record review
Intensive care unit length of stay, as measured by medical record review
Number of patients with grade 2+ graft-versus-host disease, as measured by medical record review
Transplant length of stay (in days), as measured by medical record review
Number of patients who returned to work, as assessed by Work Assessment
Number of falls, as assessed by Falls questionnaire
Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
Number of subjects who experienced delirium, as assessed by DOS assessment
The Delirium Observation Screening Scale is a 13-item observational scale of verbal and nonverbal behavior. The observations can be done during regular care. The DOS is used to optimize recognition of delirium.
Change in quality of life, as assessed by FACT-BMT assessment
50 item assessment. Higher total and domain scores indicate greater quality of life.
Change in quality of life, as assessed by EQ-5D-5L assessment
The 5D represents 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Five levels of severity are measured, as indicated by the "5L," ranging from "no problems" to "extreme problems." All scores are converted into a summary index.
Change in quality of life, as assessed by OARS IADL assessment
OARS IADL is a 7 item assessment that asks what level of assistance is needed to do 7 different activities of daily living

Full Information

First Posted
February 2, 2022
Last Updated
December 16, 2022
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05238376
Brief Title
Survivorship Post-HCT Optimization Program
Acronym
S-POP
Official Title
The Effect of High-intensity Interval Training (HIIT) and Resistance Training on Function, Health, and Quality of Life Outcomes Following Hematopoietic Stem Cell Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this project is to investigate the effects of 12 weeks of high-intensity interval training (HIIT) and resistance training on several domains of health including physical function, cognitive function, mental health, and quality of life in patients who have undergone hematopoietic stem cell transplant (HCT). In addition, the project will determine the effects of 12 weeks of HIIT and resistance training on physical function, caregiver strain, mental health, and caregiver confidence in individuals who are providing care for patients undergoing HCT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Experimental
Arm Description
These are patients who are 90 (±30) days post-allogeneic hematopoietic stem cell transplant. Patients will complete 12 weeks of exercise training. Patients will also complete assessments to evaluate physical function, cognitive function, mental health, social support, nutrition and diet, symptoms, quality of life, and financial status. They will use devices to capture activity data and vital signs. They will collect bio-specimens to assess microbiota and biomarkers.
Arm Title
Caregiver
Arm Type
Experimental
Arm Description
These are the assigned caregivers for the transplant patients. Caregivers will complete 12 weeks of exercise training. Caregivers will also complete assessments to evaluate physical function, caregiver support, and physical activity and exercise. They will collect bio-specimens to assess microbiota.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
12 weeks of high intensity interval training (HIIT) (3x/week) and resistance training (2x/week)
Primary Outcome Measure Information:
Title
Adherence to prescribed exercise program, as measured by number of total sessions completed
Time Frame
12 weeks
Title
Compliance to prescribed HIIT sessions, as measured by total session time (in minutes)
Time Frame
12 weeks
Title
Compliance to prescribed HIIT sessions, as measured by number of intervals completed
Time Frame
12 weeks
Title
Compliance to prescribed HIIT sessions, as measured by number/percentage of intervals meeting target heart rates
Time Frame
12 weeks
Title
Compliance to prescribed resistance sessions, as measured by number of sets completed
Time Frame
12 weeks
Title
Compliance to prescribed resistance sessions, as measured by number of repetitions completed
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in physical function/activity, as measured by SPPB
Description
All the task points are added which make the SPPB score. The cut-point for the SPPB is a score of 10. The cumulative and sections scores are assessed individually and comprehensively. This assessment score will be used as a tool for evaluating lower extremity functioning in older persons.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in physical function/activity, as measured by 6-minute walk test
Description
The baseline for each patient is made through an algorithm that factors the patients age and gender. The patient's score is compared to what a person that is the patient's same age and gender would get. This comparison is then used as a tool to assess aerobic capacity or endurance.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in physical function/activity, as measured by 30-second sit-to-stand
Description
Subjects will sit in a chair with their arms crossed over their chest and rise to a standing position, then return to seated position. They will repeat this as many times as they can in 30 seconds.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in physical function/activity, as measured by grip strength
Description
The hand grip is an indicator of upper body strength and has been found to be a good predictor of future functional limitations and disabilities. The hand grip score is determined based on how quickly the participant can squeeze the hand dynamometer.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in physical function/activity, as measured by Fried Frailty
Description
The scores of all of the sections are added and if the patient has a score greater or equal to three this assessment deems that the patients is frail. If the patient has a score between 1-2 the patient is deemed pre-frail.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in physical function/activity, as measured by PROMIS Physical Function
Description
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in physical function/activity, as measured by bioelectrical impedance (BIA)
Description
Participants will have body composition assessed by bioelectrical impedance spectroscopy (BIS) via a bioimpedance analysis (BIA) device. BIA equipment does not measure muscle mass directly, but instead derives an estimate of muscle mass based on whole-body electrical conductivity.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in physical function/activity, as measured by CPET
Description
Exercise capacity will be assessed using a symptom-limited Cardiopulmonary Exercise Test (CPET) on a cycle ergometer or for a six-minute step test with expired gas analysis to determine VO2peak, according to guidelines for clinical populations (Jones et al., 2012). All CPET data will be recorded as the highest 30-second value elicited during the CPET.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in physical function/activity, as measured by Intramuscular Adipose Tissue (IMAT)
Description
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus. Complex grayscale analysis of the images is used to calculate the IMAT.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in physical function/activity, as measured by Intramuscular Glycogen Content (IMGC)
Description
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus. Complex grayscale analysis of the images is used to calculate the IMGC.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in physical function/activity, as measured by muscle thickness
Description
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus, using greyscale analyses.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in physical function/activity, as measured by muscle area
Description
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus, using greyscale analyses.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in physical function/activity, as measured by subcutaneous fat layer thickness
Description
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus, using greyscale analyses.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in cognitive function, as measured by Montreal Cognitive Assessment (MOCA)
Description
This administered assessment is subdivided into visuospatial/executive (5pts), naming (3pts), memory (no points), attention(5pts), language(3pts), abstraction(2pts), delayed recall(5pts), and orientation(6pts). All the subdivided sections have as many questions as they have points. For analysis, the cut point is if the patient has less than 26 points.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in cognitive function, as measured by PROMIS Cognitive Function
Description
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in cognitive function, as measured by RBANS
Description
RBANS evaluation produces five index scores as well as a total summary score, and total scaled score. Scores range from 40 to 160, with higher scores indicating better performance (Smith et al., 2014). The scaled score classifies neuropsychological performance as: extremely low (69 and below), borderline (70-79), low average (80-89), average (90-109), high average (110-119), superior (120-129), and very superior (130 and above) (Batty et al., 2016; Randolph et al., 1998).
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in cognitive function, as measured by Trail making test
Description
Trail Making Test parts A and B (TMT-A and -B) will be used for identification of cognitively impairment. Total time to completion will be used as outcome variable for both parts (ranging from 0 to 300 seconds, with higher scores indicating worse performance (Smith et al., 2014). An adjusted mean T-score also will be calculated ranging from 0 to 100 (mean score 50, higher score indicating better performance). The T-score can be adjusted for age, sex, education and ethnicity.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in cognitive function, as measured by Brief Cope
Description
Scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in mental health, as measured by PHQ-9
Description
The PHQ-9 consists of 9 items, each of which is scored 0 to 3, giving a 0 to 27 severity score
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in mental health, as measured by PC-PTSD/PCL-5
Description
PC-PTSD is a 5 item screen to identify patients with probable PTSD. If the patient screens positive, they then take the PCL-5. The PCL-5 is a 20 item screen to assess symptoms of PTSD.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in mental health, as measured by PROMIS Depression
Description
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in mental health, as measured by PROMIS Anxiety
Description
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in diet/nutrition, as measured by Perioperative Nutrition Screen (PONS)
Description
PONS analyzes BMI, weight loss, and food intake to screen for preoperative nutrition risk
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in diet/nutrition, as measured by PG-SGA/Clinician SGA
Description
Scores for each section can range from 0-4 depending on severity and nutritional impact. The sum of all scores provides the Total PG-SGA score, which can be used to indicate the need for intervention (Bauer et al., 2002)
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in diet/nutrition, as measured by ASA-24
Description
ASA-24 is a self-administered 24-hour diet recall
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in diet/nutrition, as measured by Food Security
Description
Participants will be given the USDA food security survey to review their food securities or insecurities. This is a 10 item survey.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in social support, as measured by PROMIS Emotional Support
Description
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in social support, as measured by PROMIS Social Isolation
Description
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in social support, as measured by Lorig Self Efficacy
Description
The Self-Efficacy to Manage Chronic Disease Scale is made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident).
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in social support, as measured by CFC-14
Description
CFC-14 is a 14 item questionnaire to assess a patient's consideration of immediate and consideration of future consequences
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in social support, as measured by Brief Resilience Scale
Description
BRS assesses the patient's ability to recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience).
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in caregiver support, as measured by Caregiver Strain index
Description
Tool to assess strain on long-term caregivers
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in caregiver support, as measured by Preparedness for Caregiving assessment
Description
Items are scored by calculating the mean of all items with a range of 0-4. The higher the score, the more prepared the caregiver feels to give care.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in caregiver support, as measured by FACT-GP
Description
21 item assessment scored on a 5-point Likert scale
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in caregiver support, as measured by PHQ-2
Description
The PHQ-9 consists of 2 items, each of which is scored 0 to 3, giving a 0 to 6 severity score
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in caregiver support, as measured by PCL-5
Description
The PCL-5 is a 20 item screen to assess symptoms of PTSD.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in caregiver support, as measured by Ego Resiliency
Description
14 item survey scored from 0-56, where a higher score indicates higher level of resiliency
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in caregiver support, as measured by PROMIS Depression
Description
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in caregiver support, as measured by PROMIS Anxiety
Description
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in caregiver support, as measured by PROMIS Emotional Support
Description
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in caregiver support, as measured by PROMIS Social Isolation
Description
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in microbiota diversity, as measured by skin swabs
Description
Skin swab samples batch sequenced and microbiome analyzed
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in microbiota diversity, as measured by stool samples
Description
Changes in stool samples as measured by 16s rRNA sequencing
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Change in biomarkers of inflammation and frailty, as measured by blood plasma samples
Description
Assays evaluating angiogenic, stromal, and inflammatory markers and markers of aging (the Pepper Panel) are used to assess inflammation and frailty
Time Frame
Baseline, Post-intervention (week 12), 1 Year
Title
Overall survival, as measured by medical record review
Time Frame
1 year
Title
Disease-free survival, as measured by medical record review
Time Frame
1 year
Title
Rate of bacterial infection, as measured by medical record review
Time Frame
1 year
Title
Rate of fungal infection, as measured by medical record review
Time Frame
1 year
Title
Rate of viral infection, as measured by medical record review
Time Frame
1 year
Title
Rate of overall infection, as measured by medical record review
Time Frame
1 year
Title
Rate of hospital admission, as measured by medical record review
Time Frame
1 year
Title
Rate of intensive care unit admission, as measured by medical record review
Time Frame
1 year
Title
Hospital length of stay, as measured by medical record review
Time Frame
1 year
Title
Intensive care unit length of stay, as measured by medical record review
Time Frame
1 year
Title
Number of patients with grade 2+ graft-versus-host disease, as measured by medical record review
Time Frame
1 year
Title
Transplant length of stay (in days), as measured by medical record review
Time Frame
1 year
Title
Number of patients who returned to work, as assessed by Work Assessment
Time Frame
1 year
Title
Number of falls, as assessed by Falls questionnaire
Description
Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
Time Frame
1 year
Title
Number of subjects who experienced delirium, as assessed by DOS assessment
Description
The Delirium Observation Screening Scale is a 13-item observational scale of verbal and nonverbal behavior. The observations can be done during regular care. The DOS is used to optimize recognition of delirium.
Time Frame
1 year
Title
Change in quality of life, as assessed by FACT-BMT assessment
Description
50 item assessment. Higher total and domain scores indicate greater quality of life.
Time Frame
Baseline, Post-intervention (12 weeks), 1 Year
Title
Change in quality of life, as assessed by EQ-5D-5L assessment
Description
The 5D represents 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Five levels of severity are measured, as indicated by the "5L," ranging from "no problems" to "extreme problems." All scores are converted into a summary index.
Time Frame
Baseline, Post-intervention (12 weeks), 1 Year
Title
Change in quality of life, as assessed by OARS IADL assessment
Description
OARS IADL is a 7 item assessment that asks what level of assistance is needed to do 7 different activities of daily living
Time Frame
Baseline, Post-intervention (12 weeks), 1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient Inclusion Criteria: ≥18 years old English speaking Within 90 ± 30 days post allogenic HCT Caregiver Inclusion Criteria: ≥18 years old English speaking Providing post-discharge care for the patient who has undergone HCT Patient and Caregiver Exclusion Criteria: Have an absolute contraindication to exercise including a recent acute cardiac event (<6 months), unstable angina, uncontrolled dysthymias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspects or known dissecting aneurism, or coronary artery disease. In addition to these absolute contraindications, the patient and caregiver will complete cardiopulmonary exercise testing (CPET) where the heart rate and heart rhythm will be monitored via a 12-lead ECG before, during, and after the test. The results from the CPET will be reviewed by a physician before the subject is cleared to participate in the HIIT and resistance training program. If the participant is not cleared by the physician following the CPET, then the patient and his or her caregiver will not be eligible to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Hill, BS
Phone
919-668-2369
Email
lauren.bohannon@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Sung, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Adult Blood and Marrow Transplant Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren B Hill, BS
Phone
919-668-2369
Email
lauren.bohannon@duke.edu
First Name & Middle Initial & Last Name & Degree
Anthony Sung, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Survivorship Post-HCT Optimization Program

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