Clinical trial NCT04423939: ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients
Official title: ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hematopoietic Steam Cell Transplantation (HCT)
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Change in Physical Function, as Measured by 6 Minute Walk Test (6MWT)
timeFrame: Baseline (~30 days before HCT), Signoff (~10 days before HCT), Day 90 post-HCT
measure: Hospital Length of Stay, as Measured by Medical Record Review
timeFrame: Up to Day 90
Secondary outcomes:
Other outcomes:
measure: Change in Shannon Diversity, as Measured by Stool Samples
timeFrame: Baseline, Day 90
measure: Change in Shannon Diversity, as Measured by Stool Samples
timeFrame: Baseline, D0, D7, D14, D21, Day 30, Day 60, Day 180, Year 1, Year 2, and Year 3
measure: Hospital Length of Stay, as Measured by Medical Record Review
timeFrame: Up to 3 years
measure: Change in Physical Function, as Measured by 6 Minute Walk Test
timeFrame: Baseline, Day 30, Day 180, Year 1, Year 2, and Year 3
measure: Clinical Outcomes, as Assessed by Adverse Events Reporting
timeFrame: Continuous from baseline
measure: Acceptability of the Intervention, as Assessed by Exit Interviews
timeFrame: Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Acceptability of the Intervention, as Assessed by the Acceptability Survey
timeFrame: Baseline, at each ACT session time point
measure: Changes in Flow Cytometry, as Measured by Blood Samples
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Changes in Metabolomics, as Measured by Blood Samples
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Changes in Biomarkers, as Measured by Blood Samples
timeFrame: Baseline, Day 14, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Microbiome Diversity, as Measured by Skin Swabs
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Symptom Severity, as Measured by PRO-CTCAE Core Symptom Assessment
timeFrame: Day 0, Year 1
measure: Change in Overall Well-being, as Measured by PROMIS Sleep Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Overall Well-being, as Measured by PROMIS Global Health Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Caregiver Quality of Life, as Measured by Self-Efficacy and Preparedness for Caregivers Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Quality of Life, as Measured by Lorig Self-Efficacy Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Quality of Life, as Measured by EQ-5D-5L Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Caregiver Quality of Life, as Measured by FACT-GP Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Quality of Life, as Measured by FACT-BMT Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Overall Well-being, as Measured by OARS IADLs Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Overall Well-being, as Measured by Fried Frailty Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Financial Status, as Measured by Financial Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Caregiver Socioeconomic Status, as Measured by SES Assessment
timeFrame: Baseline, D180, Year 1, Year 2, and Year 3
measure: Change in Financial Status, as Measured by COST-FACIT Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Social Well-being, as Measured by CMS Social Determinants of Health (SDOH) Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Nutrition, as Measured by ASA-24 Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Nutrition, as Measured by PG-SGA/Clinician SGA Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Nutrition, as Measured by Perioperative Nutrition Screen (PONS)
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Nutrition, as Measured by Body Mass Index (BMI)
timeFrame: Continuous from baseline
measure: Change in Nutrition, as Measured by Albumin Values
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Mental Health, as Measured by Brief COPE Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Mental Health, as Measured by HHI-12 Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Mental Health, as Measured by PROMIS Social Isolation Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Mental Health, as Measured by PROMIS Emotional Support Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Mental Health, as Measured by PROMIS Anxiety Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Mental Health, as Measured by PROMIS Depression Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Mental Health, as Measured by PC-PTSD/PCL-5 Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Target Engagement (Process of Change), as Assessed by Valuing Questionnaire (VQ)
timeFrame: Baseline, Day 90
measure: Change in Depression Score, as Measured by PHQ-9 Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Cognitive Function, as Measured by PROMIS Cognitive Function Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Cognitive Function, as Measured by Montreal Cognitive Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Physical Function, as Measured by PROMIS Physical Function Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Physical Function, as Measured by PROMIS Fatigue Assessment
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Number of Falls, as Assessed by Falls Questionnaire
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Step Count, as Measured by Activity Tracker
timeFrame: Continuous from baseline up to 3 years
measure: Change in Physical Function, as Measured by 30 Second Sit-stand
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
measure: Change in Physical Function, as Measured by Short Physical Performance Battery (SPPB)
timeFrame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
Locations:
city: Raleigh
country: United States
facility: Lauren Hill
state: North Carolina
Study officials:
affiliation: Duke University
name: Anthony Sung, MD
role: PRINCIPAL_INVESTIGATOR
References: