Clinical trial NCT03537963: Improving Sleep in BMT Survivors
Official title: Developing and Testing an mHealth Stepped-Care Intervention for Sleep Disturbance in HCT Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Sleep Disorder
Keywords: HCT survivors
hematopoietic stem cell transplant (HCT)
survivors of hematopoietic stem cell transplant
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2018-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

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
* 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.

Exclusion Criteria:

* Do not meet Inclusion Criteria

Primary outcomes:
measure: Rate of Participant Completion of Study
timeFrame: Up to 60 days
measure: Rate of Participant Satisfaction
timeFrame: 60 days post intervention
Secondary outcomes:
measure: Rate of Sleep Disturbance
timeFrame: 60 days post intervention
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Brian Gonzalez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: