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Protocol Details

A Randomized Controlled Trial to Determine the Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Non-English Speaking


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

Recruitment Keyword(s)



Stress, Psychological;

Investigational Drug(s)


Investigational Device(s)



Other: Stress reduction intervention

Supporting Site

National Heart, Lung and Blood InstituteNIH Clinical Center


- 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.


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


- 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.


- 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.

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-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


-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

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Lena Jumin Lee (Park), Ph.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 2B07
10 Center Drive
Bethesda, Maryland 20892
(301) 451-1266

Lena Jumin Lee (Park), Ph.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 2B07
10 Center Drive
Bethesda, Maryland 20892
(301) 451-1266

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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