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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

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:

≥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.

Sites / Locations

Duke Adult Blood and Marrow Transplant ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

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)

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

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

Change in mental health, as measured by PROMIS Anxiety

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

Change in social support, as measured by PROMIS Social Isolation

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

Change in caregiver support, as measured by PROMIS Anxiety

Change in caregiver support, as measured by PROMIS Emotional Support

Change in caregiver support, as measured by PROMIS Social Isolation

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

NCT ID

NCT05238376

First Posted

February 2, 2022

Last Updated

December 16, 2022

Sponsor

Duke University

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

Studies a U.S. FDA-regulated Device Product

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

Arm Title

Caregiver

Arm Type

Experimental

Arm Description

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

Time Frame