- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04423939
ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients
October 4, 2022 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
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- 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
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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 |
Intervention / Treatment |
---|---|
Experimental: Hematopoietic Stem Cell Transplantation (HCT) Patients
20 HCT patients at Duke
|
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
|
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Day 90
|
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
|
Change in Shannon diversity, as measured by stool samples
Time Frame: Baseline, Day 90
|
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)
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
October 14, 2020
Primary Completion (Actual)
May 19, 2022
Study Completion (Anticipated)
February 17, 2025
Study Registration Dates
First Submitted
June 5, 2020
First Submitted That Met QC Criteria
June 5, 2020
First Posted (Actual)
June 9, 2020
Study Record Updates
Last Update Posted (Actual)
October 6, 2022
Last Update Submitted That Met QC Criteria
October 4, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID 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.
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