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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hematopoietic Steam Cell Transplantation (HCT)

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy (ACT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hematopoietic Stem Cell Transplantation (HCT) Patients<br>20 HCT patients at Duke | Behavioral: Acceptance and Commitment Therapy (ACT)<br>* 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.<br>|
| Experimental: Caregivers<br>20 HCT patients caregivers at Duke | Behavioral: Acceptance and Commitment Therapy (ACT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical function, 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. | Baseline, Day 90 | 
| Hospital length of stay, as measured by medical record review | Hospital length of stay in days | Up to Day 90 | 
| Change in Shannon diversity, as measured by stool samples | Stool samples assessed by 16s rRNA sequencing | Baseline, Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical function, as measured by short physical performance battery (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. | 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 | 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 | Activity tracker tracks number of steps per day | Continuous from baseline up to 3 years | 
| 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 | Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3 | 
| Change in physical function, as measured by PROMIS Fatigue assessment | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | BMI can be associated with a patient's nutritional health | Continuous from baseline | 
| Change in nutrition, as measured by Perioperative Nutrition Screen (PONS) | 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 | 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 | 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 | 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 | 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 | Questionnaire to assess caregiver socioeconomic status | Baseline, D180, Year 1, Year 2, and Year 3 | 
| Change in financial status, as measured by financial assessment | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Post-HCT clinical outcomes (i.e. GVHD) | Continuous from baseline | 
| Change in physical function, 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. | Baseline, Day 30, Day 180, Year 1, Year 2, and Year 3 | 
| Hospital length of stay, as measured by medical record review | Hospital length of stay in days | Up to 3 years | 
| Change in Shannon diversity, as measured by stool samples | 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 |