Improving Sleep in BMT Survivors
Developing and Testing an mHealth Stepped-Care Intervention for Sleep Disturbance in HCT Survivors
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to: To test a new intervention for sleep disturbance among hematopoietic cell transplant survivors. About 60 hematopoietic cell transplant (HCT) survivors will participate in this intervention. Preliminary Steps: To conduct qualitative interviews with patients, caregivers, and clinicians regarding sleep disturbance in hematopoietic cell transplant (HCT) survivors and on preferences for a new mHealth intervention for sleep disturbance. About 30 individuals (10 HCT survivors, 10 caregivers and 5-10 clinicians) will participate in this part of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2018
CompletedStudy Start
First participant enrolled
May 15, 2018
CompletedFirst Posted
Study publicly available on registry
May 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2024
CompletedFebruary 6, 2026
February 1, 2026
1.1 years
May 9, 2018
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of Participant Completion of Study
The study will be considered feasible if 70% of those who participate complete the intervention.
Up to 60 days
Rate of Participant Satisfaction
The study will be considered acceptable if 50% of eligible patients approached for study participation sign consent and if \> 50% of the mHealth stepped-care intervention group participants report that they are at least "mostly satisfied" with the intervention on a validated satisfaction scale. That is, at least half report an average score of ≥ 3 on a scale of 1 to 4 on this instrument.
60 days post intervention
Secondary Outcomes (1)
Rate of Sleep Disturbance
60 days post intervention
Study Arms (4)
Pre-Intervention Qualitative Interviews
OTHERHematopoietic 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.
mHealth Stepped-care Intervention
EXPERIMENTALFor HCT survivors randomized to this group: Baseline survey, followed by mHealth Stepped-care intervention, post-intervention questionnaire and interview.
Educational Control Condition
ACTIVE COMPARATORFor HCT survivors randomized to this group: Baseline survey, followed by Educational Control intervention, post-intervention questionnaire and interview.
mHealth Stepped-care Intervention + virtual reality relaxation
EXPERIMENTALFor HCT survivors randomized to this group: Baseline survey, followed by mHealth Stepped-care intervention + virtual reality relaxation component, post-intervention questionnaire and interview.
Interventions
Qualitative interviews will be gathered after the participants have completed participation in the new intervention to gather data to inform future refinements of the intervention.
To conduct qualitative interviews with patients, caregivers, and clinicians regarding sleep disturbance in HCT survivors and on preferences for a new mHealth intervention for sleep disturbance. Separate panels of 10 HCT survivors, 10 caregivers who were the primary caregiver of an HCT survivor during or after the inpatient HCT hospitalization, and 5-10 HCT clinicians will be recruited for individual qualitative interviews via telephone or in person.
The intervention will comprise six 360º videos of relaxing natural landscapes from which patients can choose (i.e., beaches, tropical scenes, calm thunderstorms, snowfall). Participants will also choose an audio accompaniment: a progressive muscle relaxation script, a deep breathing exercise script, a mindfulness meditation script, or scene-relevant audio (e.g., waves crashing for the beach scene).
Test of the feasibility and acceptability of an mHealth stepped-care intervention for sleep disturbance in HCT survivors, to compare with the control group.
General health education for cancer survivors provided in NCI booklets entitled Facing Forward: Life After Cancer Treatment and Coping With Advanced Cancer.
After the intervention, participants will be asked to complete a questionnaire to provide feedback on the intervention.
Eligibility Criteria
You may qualify if:
- FOR QUALITATIVE INTERVIEWS PRE-TEST
- HCT survivors: Potentially eligible patients will be approached in person during a routine outpatient appointment at Moffitt Cancer Center or via telephone.
- Additional eligibility criteria for HCT survivors will require that participants have undergone an allogeneic HCT within the previous 6 months - 2 years for a hematologic malignancy and be reporting clinically significant sleep disturbance (≥ 4 on a scale of 0 - 10).
- Caregivers of HCT survivors: Patient 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.
- Adults ≥ 18 years old
- Able to speak and read English
- Able to provide informed consent
- Have no documented or observable severe and untreated neurological or psychiatric disorders that would preclude participation (e.g., psychosis).
- Clinicians: Eligible clinicians will be oncologists, nurses, or other clinicians at the Moffitt Cancer Center Blood and Marrow Transplant Program.
- FOR INTERVENTION GROUPS
- Are ≥18 years of age
- Have been diagnosed with a hematologic malignancy
- Were discharged after allogeneic HCT within the previous 110 days (to allow for those who return to clinic within approximately 2 weeks of their planned 90-day clinic visit)
- Are experiencing clinically significant sleep disturbance
- Have never been diagnosed with nor are at high risk of sleep disorders that are unlikely to be ameliorated with behavioral treatment (e.g., obstructive sleep apnea, restless leg syndrome) as assessed using the Duke Structured Interview for Sleep Disorders
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Gonzalez, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2018
First Posted
May 25, 2018
Study Start
May 15, 2018
Primary Completion
June 29, 2019
Study Completion
April 19, 2024
Last Updated
February 6, 2026
Record last verified: 2026-02