ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients

November 20, 2025 updated by: Duke University
This is a research study to develop and test a novel protocol to reduce physical and psychological vulnerabilities that contribute to treatment intolerance and treatment-related morbidity and mortality among hematopoietic stem cell transplant (HCT) patients. When the participant enrolls in this study, they will be asked to participate in acceptance and commitment therapy (ACT) as well as complete in-person physical function tests and a cognitive test. They will also receive training on how to use iOS devices (e.g. iPad, iPhone) and activity trackers (e.g. Apple Watch), which will be provided to them during the duration of study participation. The study team will ask you to complete multiple surveys about emotional and cognitive function, diet and social support, and ask the participant to provide feedback about the treatment (e.g., what they liked or did not like). The study team will also ask the participant to provide stool samples for analysis of the bacteria in intestines, skin surface swabs for analysis of the bacteria on skin and blood samples for analysis of biomarkers and metabolites. Biomarkers and metabolites are molecular and cellular parts that deal with genetic makeup, like DNA, RNA, protein, and/or other naturally occurring substances that may be associated with transplant outcomes. Participants can expect to be enrolled in this study for 3 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Raleigh, North Carolina, United States, 27608
        • Lauren Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Patient:

  • Over the age of 18
  • Undergoing allogeneic HCT for any cancer or noncancer illness
  • English speaking
  • Has a caregiver willing to participate

Caregiver:

  • Over the age of 18
  • English speaking

Exclusion Criteria:

  • Under the age of 18
  • Non-English speaking
  • Has a caregiver unwilling to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hematopoietic Stem Cell Transplantation (HCT) Patients
20 HCT patients at Duke
Behavioral: Acceptance and Commitment Therapy (ACT)
The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.
Experimental: Caregivers
20 HCT patients caregivers at Duke
Behavioral: Acceptance and Commitment Therapy (ACT)
The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT)
Time Frame: Baseline (~30 days before HCT), Signoff (~10 days before HCT), Day 90 post-HCT
The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Baseline (~30 days before HCT), Signoff (~10 days before HCT), Day 90 post-HCT
Hospital Length of Stay, as Measured by Medical Record Review
Time Frame: Up to Day 90
Hospital length of stay in days
Up to Day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in physical function, as measured by short physical performance battery (SPPB)
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in physical function, as measured by 30 second sit-stand
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in step count, as measured by activity tracker
Time Frame: Continuous from baseline up to 3 years
Activity tracker tracks number of steps per day
Continuous from baseline up to 3 years
Number of falls, as assessed by Falls questionnaire
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in physical function, as measured by PROMIS Fatigue assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in physical function, as measured by PROMIS Physical Function assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in cognitive function, as measured by Montreal Cognitive Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in cognitive function, as measured by PROMIS Cognitive Function assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in depression score, as measured by PHQ-9 assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
The PHQ-9 consists of 9 items, each of which is scored 0 to 3, giving a 0 to 27 severity score
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Target engagement (process of change), as assessed by Valuing Questionnaire (VQ)
Time Frame: Baseline, every 2 weeks until Day 30, Day 60, Day 90
The VQ is a 10-item self-report questionnaire that assesses how closely a person is living in align with their values over the last week.
Baseline, every 2 weeks until Day 30, Day 60, Day 90
Change in mental health, as measured by PC-PTSD/PCL-5 assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in mental health, as measured by PROMIS Depression assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in mental health, as measured by PROMIS Anxiety assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in mental health, as measured by PROMIS Emotional Support assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in mental health, as measured by PROMIS Social Isolation assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in mental health, as measured by HHI-12 assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
The HHI-12 is an adapted 12 question version of the Hearth Hope Scale that assesses a patient's sense of hope
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in mental health, as measured by Brief COPE assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in nutrition, as measured by albumin values
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Albumin levels can be associated with a patient's nutritional health
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in nutrition, as measured by body mass index (BMI)
Time Frame: Continuous from baseline
BMI can be associated with a patient's nutritional health
Continuous from baseline
Change in nutrition, as measured by Perioperative Nutrition Screen (PONS)
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
PONS analyzes BMI, weight loss, and food intake to screen for preoperative nutrition risk
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in nutrition, as measured by PG-SGA/Clinician SGA assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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)
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in nutrition, as measured by ASA-24 assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
ASA-24 is a self-administered 24-hour diet recall
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in social well-being, as measured by CMS Social Determinants of Health (SDOH) assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
CMS SDOH is a 10 item survey that assesses 5 domains of social needs
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in financial status, as measured by COST-FACIT assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
COST-FACIT is an 11-item questionnaire that assesses a patient's financial toxicity
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in caregiver socioeconomic status, as measured by SES assessment
Time Frame: Baseline, D180, Year 1, Year 2, and Year 3
Questionnaire to assess caregiver socioeconomic status
Baseline, D180, Year 1, Year 2, and Year 3
Change in financial status, as measured by financial assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
22-item questionnaire to assess how a patient's care as affected their finances
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in overall well-being, as measured by Fried Frailty assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in overall well-being, as measured by OARS IADLs assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
OARS IADL is a 7 item assessment that asks what level of assistance is needed to do 7 different activities of daily living
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in quality of life, as measured by FACT-BMT assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
50 item assessment. Higher total and domain scores indicate greater quality of life.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in caregiver quality of life, as measured by FACT-GP assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
21 item assessment scored on a 5-point Likert scale
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in quality of life, as measured by EQ-5D-5L assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in quality of life, as measured by Lorig Self-Efficacy assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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).
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in caregiver quality of life, as measured by Self-Efficacy and Preparedness for Caregivers assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
9-item questionnaire to assess preparedness for caregiving
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in overall well-being, as measured by PROMIS Global Health assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in overall well-being, as measured by PROMIS Sleep assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in symptom severity, as measured by PRO-CTCAE core symptom assessment
Time Frame: Weekly through Year 1
Assessing changes in severity of 23 core symptoms that are typically associated with HCT
Weekly through Year 1
Change in microbiome diversity, as measured by skin swabs
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Skin swab samples batch sequenced and microbiome analyzed
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Changes in biomarkers, as measured by blood samples
Time Frame: Baseline, Day 14, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Assays evaluating angiogenic, stromal, and inflammatory markers and markers of aging (the Pepper Panel) are used to assess inflammation and frailty.
Baseline, Day 14, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Changes in metabolomics, as measured by blood samples
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Approximately 1ml of plasma from the EDTA tube will be used for metabolomics analysis.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Changes in flow cytometry, as measured by blood samples
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Whole blood samples, will be analyzed and monitored for outcomes such as immune cell differentiation, immune response and development of GVHD. Flow cytometry will be performed.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Acceptability of the intervention, as assessed by the Acceptability survey
Time Frame: Baseline, at each ACT session time point
6-item survey to assess patients' opinion on the ACT program
Baseline, at each ACT session time point
Acceptability of the intervention, as assessed by exit interviews
Time Frame: Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Exit interviews to assess patients' opinion on the ACT program
Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Clinical outcomes, as assessed by adverse events reporting
Time Frame: Continuous from baseline
Post-HCT clinical outcomes (i.e. GVHD)
Continuous from baseline
Change in physical function, as measured by 6 minute walk test
Time Frame: Baseline, Day 30, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 180, Year 1, Year 2, and Year 3
Hospital length of stay, as measured by medical record review
Time Frame: Up to 3 years
Hospital length of stay in days
Up to 3 years
Change in Shannon diversity, as measured by stool samples
Time Frame: Baseline, D0, D7, D14, D21, Day 30, Day 60, Day 180, Year 1, Year 2, and Year 3
Stool samples assessed by 16s rRNA sequencing
Baseline, D0, D7, D14, D21, Day 30, Day 60, Day 180, Year 1, Year 2, and Year 3

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Shannon Diversity, as Measured by Stool Samples
Time Frame: Baseline, Day 90
Stool samples assessed by 16s rRNA sequencing
Baseline, Day 90
Change in Shannon Diversity, as Measured by Stool Samples
Time Frame: Baseline, D0, D7, D14, D21, Day 30, Day 60, Day 180, Year 1, Year 2, and Year 3
Stool samples assessed by 16s rRNA sequencing
Baseline, D0, D7, D14, D21, Day 30, Day 60, Day 180, Year 1, Year 2, and Year 3
Hospital Length of Stay, as Measured by Medical Record Review
Time Frame: Up to 3 years
Hospital length of stay in days
Up to 3 years
Change in Physical Function, as Measured by 6 Minute Walk Test
Time Frame: Baseline, Day 30, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 180, Year 1, Year 2, and Year 3
Clinical Outcomes, as Assessed by Adverse Events Reporting
Time Frame: Continuous from baseline
Post-HCT clinical outcomes (i.e. GVHD)
Continuous from baseline
Acceptability of the Intervention, as Assessed by Exit Interviews
Time Frame: Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Exit interviews to assess patients' opinion on the ACT program
Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Acceptability of the Intervention, as Assessed by the Acceptability Survey
Time Frame: Baseline, at each ACT session time point
6-item survey to assess patients' opinion on the ACT program
Baseline, at each ACT session time point
Changes in Flow Cytometry, as Measured by Blood Samples
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Whole blood samples, will be analyzed and monitored for outcomes such as immune cell differentiation, immune response and development of GVHD. Flow cytometry will be performed.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Changes in Metabolomics, as Measured by Blood Samples
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Approximately 1ml of plasma from the EDTA tube will be used for metabolomics analysis.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Changes in Biomarkers, as Measured by Blood Samples
Time Frame: Baseline, Day 14, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Assays evaluating angiogenic, stromal, and inflammatory markers and markers of aging (the Pepper Panel) are used to assess inflammation and frailty.
Baseline, Day 14, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Microbiome Diversity, as Measured by Skin Swabs
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Skin swab samples batch sequenced and microbiome analyzed
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Symptom Severity, as Measured by PRO-CTCAE Core Symptom Assessment
Time Frame: Day 0, Year 1
Assessing changes in severity of core symptoms that are typically associated with HCT
Day 0, Year 1
Change in Overall Well-being, as Measured by PROMIS Sleep Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Overall Well-being, as Measured by PROMIS Global Health Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Caregiver Quality of Life, as Measured by Self-Efficacy and Preparedness for Caregivers Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
9-item questionnaire to assess preparedness for caregiving
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Quality of Life, as Measured by Lorig Self-Efficacy Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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).
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Quality of Life, as Measured by EQ-5D-5L Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Caregiver Quality of Life, as Measured by FACT-GP Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
21 item assessment scored on a 5-point Likert scale
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Quality of Life, as Measured by FACT-BMT Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
50 item assessment. Higher total and domain scores indicate greater quality of life.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Overall Well-being, as Measured by OARS IADLs Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
OARS IADL is a 7 item assessment that asks what level of assistance is needed to do 7 different activities of daily living
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Overall Well-being, as Measured by Fried Frailty Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Financial Status, as Measured by Financial Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
22-item questionnaire to assess how a patient's care as affected their finances
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Caregiver Socioeconomic Status, as Measured by SES Assessment
Time Frame: Baseline, D180, Year 1, Year 2, and Year 3
Questionnaire to assess caregiver socioeconomic status
Baseline, D180, Year 1, Year 2, and Year 3
Change in Financial Status, as Measured by COST-FACIT Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
COST-FACIT is an 11-item questionnaire that assesses a patient's financial toxicity
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Social Well-being, as Measured by CMS Social Determinants of Health (SDOH) Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
CMS SDOH is a 10 item survey that assesses 5 domains of social needs
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Nutrition, as Measured by ASA-24 Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
ASA-24 is a self-administered 24-hour diet recall
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Nutrition, as Measured by PG-SGA/Clinician SGA Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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)
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Nutrition, as Measured by Perioperative Nutrition Screen (PONS)
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
PONS analyzes BMI, weight loss, and food intake to screen for preoperative nutrition risk
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Nutrition, as Measured by Body Mass Index (BMI)
Time Frame: Continuous from baseline
BMI can be associated with a patient's nutritional health
Continuous from baseline
Change in Nutrition, as Measured by Albumin Values
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Albumin levels can be associated with a patient's nutritional health
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Mental Health, as Measured by Brief COPE Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Mental Health, as Measured by HHI-12 Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
The HHI-12 is an adapted 12 question version of the Hearth Hope Scale that assesses a patient's sense of hope
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Mental Health, as Measured by PROMIS Social Isolation Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Mental Health, as Measured by PROMIS Emotional Support Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Mental Health, as Measured by PROMIS Anxiety Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Mental Health, as Measured by PROMIS Depression Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Mental Health, as Measured by PC-PTSD/PCL-5 Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Target Engagement (Process of Change), as Assessed by Valuing Questionnaire (VQ)
Time Frame: Baseline, Day 90
The VQ is a 10-item self-report questionnaire that assesses how closely a person is living in align with their values over the last week. Progress (range = 0 to 30) is defined as enactment and perseverance in living consistently with one's values; higher scores represent a closer alignment between one's internal values and one's actions. Obstruction (range = 0 to 30) represents the extent to which various disruptions got in the way of valued living; higher scores represent more interference with living consistently with one's values. The baseline and day 90 VQ scores are reported.
Baseline, Day 90
Change in Depression Score, as Measured by PHQ-9 Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
The PHQ-9 consists of 9 items, each of which is scored 0 to 3, giving a 0 to 27 severity score
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Cognitive Function, as Measured by PROMIS Cognitive Function Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Cognitive Function, as Measured by Montreal Cognitive Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Physical Function, as Measured by PROMIS Physical Function Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Physical Function, as Measured by PROMIS Fatigue Assessment
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Number of Falls, as Assessed by Falls Questionnaire
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Step Count, as Measured by Activity Tracker
Time Frame: Continuous from baseline up to 3 years
Activity tracker tracks number of steps per day
Continuous from baseline up to 3 years
Change in Physical Function, as Measured by 30 Second Sit-stand
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Change in Physical Function, as Measured by Short Physical Performance Battery (SPPB)
Time Frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
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.
Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anthony Sung, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00105683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hematopoietic Steam Cell Transplantation (HCT)

Clinical Trials on Acceptance and Commitment Therapy (ACT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings