Sleep DisturbanceNCT03537963
Improving Sleep in BMT Survivors
A study testing mHealth Stepped-care Intervention, Questionnaire and Interview in people with Sleep Disturbance and Sleep Disorder, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Sleep Disorder
- What is being tested?
- mHealth Stepped-care Intervention, Questionnaire and Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 19 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
- Are able to sign informed consent
- Do not have any untreated or severe psychiatric or neurological disorders or other disabilities that would impair their ability to participate in this study.
Who cannot join
- Do not meet Inclusion Criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Developing and Testing an mHealth Stepped-Care Intervention for Sleep Disturbance in HCT Survivors
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.
Read the detailed description
Investigators will collect qualitative interview data from HCT survivors, caregivers, and clinicians to inform the development of a new mHealth intervention. Then, this new intervention will be developed by adapting existing interventions that were originally designed for other cancer and non-cancer populations.A virtual reality relaxation component will also be developed as an adjunct to the mHealth stepped-care intervention.
Intervention participants will complete a baseline survey via the internet about their demographics, health, and well-being. The baseline survey also includes questions about their sleep and will take approximately 1 hour to complete.
Participants will then be provided brief behavioral therapy through the mHealth intervention. Participants would be monitored passively via actigraphy for the next 30 days. Those who continue demonstrating clinically significant sleep disturbance 30 days after starting the intervention would then receive a more intensive therapy with a trained therapist via videoconferencing. This videoconferencing therapy, adapted from cognitive behavioral therapy for insomnia, will also be a built-in part of the mHealth intervention. Thus, the new mHealth intervention will be delivered via mobile device to enhance disseminability and improve access for survivors who typically live long distances from their HCT center.
Then Sixty HCT survivors with clinically significant sleep disturbance will be recruited 90 days after HCT and be block-randomized based on sex to receive usual care (n=20), the new mHealth stepped-care intervention (n=20), or the new mHealth stepped-care intervention +virtual relaxation component (n=20). Outcomes will be assessed before randomization as well as 30 and 60 days later. Participants will complete a validated self-report measure of sleep disturbance, and for objective measurement of sleep participants will be asked to wear a Fitbit and allow Fitbit data to be uploaded to the intervention for customizing individuals' interventions.
After the intervention, participants will be asked to complete a questionnaire to provide feedback on the intervention and participate in a post-intervention interview with a member of the study team.
- Conditions
- Sleep Disturbance, Sleep Disorder
- Being tested
- mHealth Stepped-care Intervention, Educational Control Condition, Questionnaire, Interview, Qualitative Interviews
- Keywords
- HCT survivors, hematopoietic stem cell transplant (HCT), survivors of hematopoietic stem cell transplant
- Medical subject headings
- Parasomnias, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Stepped-care InterventionOther
Test of the feasibility and acceptability of an mHealth stepped-care intervention for sleep disturbance in HCT survivors, to compare with the control group.
Educational Control ConditionOther
General health education for cancer survivors provided in NCI booklets entitled Facing Forward: Life After Cancer Treatment and Coping With Advanced Cancer.
QuestionnaireOther
After the intervention, participants will be asked to complete a questionnaire to provide feedback on the intervention.
InterviewOther
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.
Qualitative InterviewsOther
Also called Questionnaire
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.
Virtual RealityOther
Also called VR
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).
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention Qualitative Interviews | Other | 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. Receives: Other: Qualitative Interviews |
| mHealth Stepped-care Intervention | Experimental | For HCT survivors randomized to this group: Baseline survey, followed by mHealth Stepped-care intervention, post-intervention questionnaire and interview. Receives: Other: mHealth Stepped-care Intervention; Other: Questionnaire; Other: Interview |
| Educational Control Condition | Active comparator | For HCT survivors randomized to this group: Baseline survey, followed by Educational Control intervention, post-intervention questionnaire and interview. Receives: Other: Educational Control Condition; Other: Questionnaire; Other: Interview |
| mHealth Stepped-care Intervention + virtual reality relaxation | Experimental | For HCT survivors randomized to this group: Baseline survey, followed by mHealth Stepped-care intervention + virtual reality relaxation component, post-intervention questionnaire and interview. Receives: Other: mHealth Stepped-care Intervention; Other: Questionnaire; Other: Interview; Other: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Participant Completion of Study
The study will be considered feasible if 70% of those who participate complete the intervention.
Measured: 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.
Measured: 60 days post intervention
Secondary outcomes (1)
Rate of Sleep Disturbance
Sleep disturbance will be operationalized by scores on the Pittsburgh Sleep Quality Index and sleep efficiency (the percentage of time spent in bed that is spent asleep). For secondary efficacy analyses participants will be categorized as having sleep disturbance if their Pittsburgh Sleep Quality Index score is ≥ 5 (for subjectively-measured sleep disturbance) and if their sleep efficiency is <85% (for objectively-measured sleep disturbance).
Measured: 60 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start15 May 2018
- Primary completion29 Jun 2019
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- After the first part of the study (Qualitative Interviews), the hematopoietic cell transplant (HCT) survivors will be randomized to 3 different study arms for the intervention portion of the study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Brian Gonzalez, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537963
- Sponsor's protocol ID
- MCC-19486
- Status last verified
- Feb 2026
- First submitted
- 9 May 2018
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing an mHealth Stepped-Care Intervention for Sleep Disturbance in HCT Survivors
- ClinicalTrials.gov ID
- NCT03537963
- Acronym / sponsor ID
- MCC-19486
- Conditions
- Sleep Disturbance, Sleep Disorder
- Keywords
- HCT survivors, hematopoietic stem cell transplant (HCT), survivors of hematopoietic stem cell transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 15 May 2018 (actual)
- Primary completion
- 29 Jun 2019 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Investigators will collect qualitative interview data from HCT survivors, caregivers, and clinicians to inform the development of a new mHealth intervention. Then, this new intervention will be developed by adapting existing interventions that were originally designed for other cancer and non-cancer populations.A virtual reality relaxation component will also be developed as an adjunct to the mHealth stepped-care intervention.
Intervention participants will complete a baseline survey via the internet about their demographics, health, and well-being. The baseline survey also includes questions about their sleep and will take approximately 1 hour to complete.
Participants will then be provided brief behavioral therapy through the mHealth intervention. Participants would be monitored passively via actigraphy for the next 30 days. Those who continue demonstrating clinically significant sleep disturbance 30 days after starting the intervention would then receive a more intensive therapy with a trained therapist via videoconferencing. This videoconferencing therapy, adapted from cognitive behavioral therapy for insomnia, will also be a built-in part of the mHealth intervention. Thus, the new mHealth intervention will be delivered via mobile device to enhance disseminability and improve access for survivors who typically live long distances from their HCT center.
Then Sixty HCT survivors with clinically significant sleep disturbance will be recruited 90 days after HCT and be block-randomized based on sex to receive usual care (n=20), the new mHealth stepped-care intervention (n=20), or the new mHealth stepped-care intervention +virtual relaxation component (n=20). Outcomes will be assessed before randomization as well as 30 and 60 days later. Participants will complete a validated self-report measure of sleep disturbance, and for objective measurement of sleep participants will be asked to wear a Fitbit and allow Fitbit data to be uploaded to the intervention for customizing individuals' interventions.
After the intervention, participants will be asked to complete a questionnaire to provide feedback on the intervention and participate in a post-intervention interview with a member of the study team.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- After the first part of the study (Qualitative Interviews), the hematopoietic cell transplant (HCT) survivors will be randomized to 3 different study arms for the intervention portion of the study.
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention Qualitative Interviews | Other | Other: Qualitative InterviewsHematopoietic 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 | Experimental | Other: mHealth Stepped-care Intervention, Other: Questionnaire, Other: InterviewFor HCT survivors randomized to this group: Baseline survey, followed by mHealth Stepped-care intervention, post-intervention questionnaire and interview. |
| Educational Control Condition | Active comparator | Other: Educational Control Condition, Other: Questionnaire, Other: InterviewFor 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 | Experimental | Other: mHealth Stepped-care Intervention, Other: Questionnaire, Other: Interview, Other: Virtual RealityFor HCT survivors randomized to this group: Baseline survey, followed by mHealth Stepped-care intervention + virtual reality relaxation component, post-intervention questionnaire and interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (1 listed)
- Do not meet Inclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth Stepped-care InterventionTest of the feasibility and acceptability of an mHealth stepped-care intervention for sleep disturbance in HCT survivors, to compare with the control group. | Other | mHealth Stepped-care Intervention, mHealth Stepped-care Intervention + virtual reality relaxation |
| Educational Control ConditionGeneral health education for cancer survivors provided in NCI booklets entitled Facing Forward: Life After Cancer Treatment and Coping With Advanced Cancer. | Other | Educational Control Condition |
| QuestionnaireAfter the intervention, participants will be asked to complete a questionnaire to provide feedback on the intervention. | Other | Educational Control Condition, mHealth Stepped-care Intervention, mHealth Stepped-care Intervention + virtual reality relaxation |
| InterviewQualitative interviews will be gathered after the participants have completed participation in the new intervention to gather data to inform future refinements of the intervention. | Other | Educational Control Condition, mHealth Stepped-care Intervention, mHealth Stepped-care Intervention + virtual reality relaxation |
| Qualitative InterviewsAlso: QuestionnaireTo 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. | Other | Pre-Intervention Qualitative Interviews |
| Virtual RealityAlso: VRThe 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). | Other | mHealth Stepped-care Intervention + virtual reality relaxation |
Primary outcome
Rate of Participant Completion of Study
Time frame: Up to 60 days
The study will be considered feasible if 70% of those who participate complete the intervention.
Rate of Participant Satisfaction
Time frame: 60 days post intervention
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.
1 secondary outcome
Rate of Sleep Disturbance
Time frame: 60 days post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Gonzalez, Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Stepped-care Intervention, Questionnaire and Interview in people with Sleep Disturbance and Sleep Disorder, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Participant Completion of Study (time frame: Up to 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.