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NCT02257853 · ClinicalTrials.gov registry record · Phase 2
Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients
A Phase 2 study of Stress, Psychological and Caregivers, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT02257853: Completed Phase 2 study of Stress, Psychological and Caregivers, sponsored by National Institutes of Health Clinical Center (CC).
NCT02257853 is a Phase 2 study of Stress, Psychological and Caregivers that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 53 participants, below the 171-participant average among 43 other Stress, Psychological trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02257853, a Phase 2 study of Stress, Psychological and Caregivers, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
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 |
What the finished NCT02257853 record still lists
NCT02257853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 171-participant average among 43 other Stress, Psychological trials with a reported enrollment target (69% lower).
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.
NCT02257853 reports a single indexed study location in Maryland.
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.
What interventions are being tested in trial NCT02257853?
The interventions under investigation include: Stress reduction intervention (OTHER).
Who is sponsoring clinical trial NCT02257853?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT02257853's enrollment target sits among peer trials
53 30th of 43 higher than 14 of 43 other Stress, Psychological trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress, Psychological trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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