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

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Duke University

Status

Active, not recruiting

Conditions

Hematopoietic Steam Cell Transplantation (HCT)

Treatments

Behavioral: Acceptance and Commitment Therapy (ACT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04423939
Pro00105683

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

33 participants in 2 patient groups

Hematopoietic Stem Cell Transplantation (HCT) Patients
Experimental group
Description:
20 HCT patients at Duke
Treatment:
Behavioral: Acceptance and Commitment Therapy (ACT)
Caregivers
Experimental group
Description:
20 HCT patients caregivers at Duke
Treatment:
Behavioral: Acceptance and Commitment Therapy (ACT)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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