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Virtual Reality and mHealth Intervention for Sleep Disorders
N/A
Recruiting
Led By Brian Gonzalez, Ph.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 days
Awards & highlights
Study Summary
This trial is testing a new intervention for sleep disturbance among hematopoietic cell transplant survivors. 60 people will participate in the trial, which will test a new way to help people who have trouble sleeping.
Who is the study for?
This trial is for adults over 18 who've had a hematopoietic cell transplant (HCT) due to blood cancer and are struggling with sleep issues. They shouldn't have untreated severe mental or neurological conditions, nor specific sleep disorders not helped by behavioral treatment.Check my eligibility
What is being tested?
The study tests a new mobile health intervention aimed at improving sleep in HCT survivors. It includes virtual reality experiences, stepped-care approaches tailored to individual needs, interviews about sleep disturbances, and educational materials as controls.See study design
What are the potential side effects?
Since the interventions involve non-invasive techniques like virtual reality and mobile health applications, side effects may be minimal but could include discomfort from VR use or stress from discussing personal experiences during interviews.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Participant Completion of Study
Rate of Participant Satisfaction
Secondary outcome measures
Rate of Sleep Disturbance
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: mHealth Stepped-care Intervention + virtual reality relaxationExperimental Treatment4 Interventions
For HCT survivors randomized to this group: Baseline survey, followed by mHealth Stepped-care intervention + virtual reality relaxation component, post-intervention questionnaire and interview.
Group II: mHealth Stepped-care InterventionExperimental Treatment3 Interventions
For HCT survivors randomized to this group: Baseline survey, followed by mHealth Stepped-care intervention, post-intervention questionnaire and interview.
Group III: Pre-Intervention Qualitative InterviewsExperimental Treatment1 Intervention
Hematopoietic cell transplant (HCT) survivors, caregivers and clinicians will participate in this part of the study. HCT survivor participants will be asked to nominate and provide contact information for the person who was their primary caregiver before, during, or after their HCT hospitalization. All participants will be asked to participate in either an in-person or telephone interview that will last approximately 1 hour. The interview will be digitally audio-recorded and will ask questions on the trajectory of sleep disturbance in HCT recipients and strategies to manage common barriers to quality sleep, as well as discuss the planned intervention for sleep disturbance in HCT survivors.
Group IV: Educational Control ConditionActive Control3 Interventions
For HCT survivors randomized to this group: Baseline survey, followed by Educational Control intervention, post-intervention questionnaire and interview.
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Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,412 Total Patients Enrolled
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,375 Total Patients Enrolled
Brian Gonzalez, Ph.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Criterion: For the pre-test interviews, survivors of hematopoietic cell transplantation (HCT) must have received a transplant within the past 6 months to 2 years for a blood cancer and have significant sleep problems. Caregivers of HCT survivors must be nominated by the patients and have been their main caregiver before, during, or after the hospital stay for the transplant. Participants must be adults over 18 years old, able to speak and read English, give informed consent, and not have severe untreated neurological or psychiatric disorders. Clinicians must be oncologists, nurses, or other healthcare providers at the Moffitt Cancer Center Blood and Marrow Transplant Program.I am over 18, had a bone marrow transplant recently, struggle with sleep but don't have major sleep disorders or severe mental health issues.
Research Study Groups:
This trial has the following groups:- Group 1: mHealth Stepped-care Intervention + virtual reality relaxation
- Group 2: mHealth Stepped-care Intervention
- Group 3: Educational Control Condition
- Group 4: Pre-Intervention Qualitative Interviews
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any further participants being accepted for this trial presently?
"Affirmative. As evidenced by the clinicaltrials.gov website, the trial is still in need of participants with 80 people being sought from 1 site since its inception on May 15th 2018 and last update on November 10th 2022."
Answered by AI
How many individuals are being monitored for the results of this clinical experiment?
"Affirmative. Clinicaltrials.gov hosts data confirming that this medical research, posted on May 15th 2018 and last revised November 10th 2022, is actively recruiting for 80 subjects from 1 healthcare centre."
Answered by AI
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