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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04423939
Recruitment Status : Active, not recruiting
First Posted : June 9, 2020
Last Update Posted : October 6, 2022
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hematopoietic Steam Cell Transplantation (HCT) Behavioral: Acceptance and Commitment Therapy (ACT) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients
Actual Study Start Date : October 14, 2020
Actual Primary Completion Date : May 19, 2022
Estimated Study Completion Date : February 17, 2025
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in physical function, as measured by 6 minute walk test [ Time Frame: Baseline, Day 90 ]
    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.

  2. Hospital length of stay, as measured by medical record review [ Time Frame: Up to Day 90 ]
    Hospital length of stay in days

  3. Change in Shannon diversity, as measured by stool samples [ Time Frame: Baseline, Day 90 ]
    Stool samples assessed by 16s rRNA sequencing


Secondary Outcome Measures :
  1. 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.

  2. 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.

  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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. 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

  19. 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

  20. 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

  21. 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)

  22. 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

  23. 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

  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 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

  26. 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

  27. 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.

  28. 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

  29. 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.

  30. 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

  31. 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.

  32. 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).

  33. 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

  34. 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.

  35. 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.

  36. 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

  37. 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

  38. 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.

  39. 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.

  40. 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.

  41. 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

  42. 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

  43. Clinical outcomes, as assessed by adverse events reporting [ Time Frame: Continuous from baseline ]
    Post-HCT clinical outcomes (i.e. GVHD)

  44. 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.

  45. Hospital length of stay, as measured by medical record review [ Time Frame: Up to 3 years ]
    Hospital length of stay in days

  46. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04423939


Locations
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United States, North Carolina
Lauren Hill
Raleigh, North Carolina, United States, 27608
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Anthony Sung, MD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Informed Consent Form  [PDF] June 30, 2022

More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04423939    
Other Study ID Numbers: Pro00105683
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No