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Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients
NCT02257853 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- OTHER Stress reduction intervention
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2015-01-05 |
| Est. Completion | 2019-02-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02257853
The ClinicalTrials.gov registry entry for NCT02257853 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 209 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Stress, Psychological appearing as the primary indexed condition, and to 1 intervention — of which Stress reduction intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02257853 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02257853 about?
NCT02257853 is a clinical study titled "Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients". 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 stre...
What is the current status of trial NCT02257853?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2015-01-05. Estimated completion is 2019-02-07.
What conditions does trial NCT02257853 study?
This clinical trial studies the following conditions: Stress, Psychological, Caregivers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02257853?
The interventions under investigation include: Stress reduction intervention (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02257853?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 209 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02257853 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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