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Completed

NCT Number: NCT04423939

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

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.

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Key information

Conditions

Hematopoietic Steam Cell Transplantation (HCT)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lauren Hill

Raleigh, North Carolina, 27608, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acceptance and Commitment Therapy (ACT)

Behavioral

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.

Primary outcomes

  1. 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.

  2. Hospital Length of Stay, as Measured by Medical Record Review

    Time frame: Up to Day 90

    Hospital length of stay in days

Other outcomes

  1. Change in Shannon Diversity, as Measured by Stool Samples

    Time frame: Baseline, Day 90

    Stool samples assessed by 16s rRNA sequencing

  2. 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

  3. Hospital Length of Stay, as Measured by Medical Record Review

    Time frame: Up to 3 years

    Hospital length of stay in days

  4. 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.

  5. Clinical Outcomes, as Assessed by Adverse Events Reporting

    Time frame: Continuous from baseline

    Post-HCT clinical outcomes (i.e. GVHD)

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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

  16. 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).

  17. 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.

  18. 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

  19. 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.

  20. 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

  21. 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.

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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)

  28. 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

  29. 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

  30. 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

  31. 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.

  32. 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

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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

  45. 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

  46. 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.

  47. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2025
First posted
Jun 9, 2020
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.