Cognitive Behavioral Therapy for Bone Marrow Transplant Recovery

Recruiting at 1 trial location

Overseen By Lauren Hill

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Under 18, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 3 years

33 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Anthony Sung, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for adults over 18 who are undergoing allogeneic hematopoietic stem cell transplant (HCT) for cancer or other illnesses, and speak English. They must have a caregiver willing to participate. It's not open to those under 18, without an English-speaking caregiver, or non-English speakers themselves.

Inclusion Criteria

Patient has a caregiver willing to participate

I am over 18 years old.

Patient is English speaking

Exclusion Criteria

My caregiver is not willing to participate in the study.

Patient is non-English speaking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in acceptance and commitment therapy (ACT), complete physical and cognitive tests, and use iOS devices and activity trackers. They also provide various biological samples for analysis.

3 years

Multiple visits (in-person and virtual) throughout the study

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of physical function, mental health, and quality of life.

3 years

Regular assessments at Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3

Treatment Details

Interventions

• Acceptance and Commitment Therapy (ACT)

Trial Overview The study tests acceptance and commitment therapy (ACT) to reduce complications in HCT patients. Participants will undergo ACT sessions, physical and cognitive tests, learn to use iOS devices and activity trackers for monitoring, complete surveys on emotional/cognitive function and provide stool samples as well as skin swabs.

Participant Groups

Group I: Hematopoietic Stem Cell Transplantation (HCT) Patients Experimental Treatment 1 Intervention

20 HCT patients at Duke

Group II: Caregivers Experimental Treatment 1 Intervention

20 HCT patients caregivers at Duke

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+