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Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

NCT02257853 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-05-22

No results posted yet for this study

Summary

Background:

\- People who have an allogeneic hematopoietic stem cell transplant (HSCT) need help as they recover. Being a caregiver can be stressful to the body and mind. Researchers want to find ways to reduce this stress.

Objective:

\- To see how a stress reduction intervention affects the stress levels and health of an HSCT caregiver.

Eligibility:

\- Adults age 18 and older who plan to be an active caregiver for a person having their first allogeneic HSCT at the NIH Clinical Center. An active caregiver is someone who will be caring for the person from just before admission for the HSCT until at least 6 weeks after.

Design:

* Participants will be put in either the intervention group or the control group.
* All participants will get the usual caregiver education given to all patients and caregivers having a stem cell transplant at the NIH Clinical Center.
* All participants will have 2 study visits. They will give blood samples. They will have health assessments and brief physical exams. They will fill out study questionnaires and have an exit interview.
* The intervention group will get an MP3 player. It will have an audio file with a stress reduction intervention on it. Participants will do this intervention daily. It takes 20 minutes. They will do gentle stretches and breathing exercises. They will get a diary to track their practice.
* The intervention group also will have follow-up phone calls 2 and 4 weeks after their first clinic visit.
* The person getting the HSCT will not be actively involved in the study.
* The study will last about 2 months....

Conditions

  • Stress, Psychological
  • Caregivers

Interventions

OTHER

Stress reduction intervention

Gentle chair yoga and breath work

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Lena J Lee, Ph.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-05
Primary Completion
2018-11-08
Completion
2019-02-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02257853 on ClinicalTrials.gov