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

NCT02257853 | Completed Phase 2

• 2 other identifiers: 14020114-CC-0201
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Caregiver Stress; Cancer Caregivers; Yoga-Based Stress Reduction Intervention; HSCT Caregivers

Outcome Measures

Primary Outcomes (1)

• Perceived stress

  To examine whether HSCT caregivers participating in a stress reduction intervention demonstrate improvement in certain individual factors (self-efficacy, burden, and mindfulness), psychosocial factors (stress, anxiety, depression, loneliness, positive affect and well-being), behaviors (health behaviors) and symptoms (sleep, fatigue, depression, and cognitive impairment) compared with HSCT caregivers in the control group.

  Pre & 6 Weeks Post

Secondary Outcomes (3)

• Cardiometabolic factors

  Pre & 6 weeks post

• Inflammatory cytokines

  Pre & 6 Weeks Post

• Self-reported symptoms

  Pre & 6 weeks post

Study Arms (2)

Control Group

NO INTERVENTION

No intervention group

Intervention

EXPERIMENTAL

Receives stress reduction intervention introduction with daily practice

Other: Stress reduction intervention

Interventions

Stress reduction intervention OTHER

Gentle chair yoga and breath work

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years old
• Ability to comprehend the investigational nature of the study
• Able to read and speak English
• Agrees to participate in the study
• Able to lift arms over head without pain
• Able to sit and stand from a seated position unassisted
• Intends to serve as an active caregiver\* for a patient undergoing their 1st allogeneic HSCT at the NIH Clinical Center

You may not qualify if:

• Age less than or equal to 18 years old
• Pregnant or lactating women
• Inability to comprehend investigational nature of study
• Inability to provide informed consent
• Unable to read and speak English
• Does not agree to participate in study or follow study design
• Serving as a paid caregiver for any individual
• Regular practitioner of yoga, meditation or other mind-body practice (definition: taking classes or practicing at least weekly for at least 2 of the past 6 months).
• Physical function limitations that would interfere with intervention
• Caregiver participants will be excluded from the biomarker analysis if they have had:
• Glucocorticosteroid treatment in the last 2 months
• Have a recent (within the last 2 months) acute illness or injury
• Have served as a stem cell transplant donor or have taken filgastrim

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Lee LJ, Shamburek R, Son H, Wallen GR, Cox R, Flynn S, Yang L, Bevans M, Wehrlen L, Ross A. Effects of a yoga-based stress reduction intervention on stress, psychological outcomes and cardiometabolic biomarkers in cancer caregivers: A randomized controlled trial. PLoS One. 2022 Nov 10;17(11):e0277009. doi: 10.1371/journal.pone.0277009. eCollection 2022.

  PMID: 36355827 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Stress, Psychological; Caregiver Burden

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Lena J Lee, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 7, 2014
• Study Start: January 5, 2015
• Primary Completion: November 8, 2018
• Study Completion: February 7, 2019
• Last Updated: April 29, 2026

Record last verified: 2025-07-08

Locations

US (1)