Intervention for Sleep Disturbance in HCT Survivors



Status:Recruiting
Conditions:Insomnia Sleep Studies, Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:May 8, 2018
End Date:June 2021

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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 50 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.

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.

Next, HCT survivors will be randomized to one of two online interventions for sleep
disturbance: To the mHealth stepped-care intervention - or - To the educational control
condition.

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 about 20 minutes to complete.

Both interventions are delivered online via a tablet device. Participants will be asked to
complete a follow-up survey via the internet about their sleep at 30 and 60 days after
starting the intervention. They will wear a small actigraph device on their wrist throughout
the 60-day intervention period. Participants will be provided with an actigraph charging
cable and dock as well as a small telemetry device that will be used to download the
actigraph data.

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.

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
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Brian Gonzalez, Ph.D.
Phone: 813-745-1814
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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mi
from
Tampa, FL
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