NCT03537963

Improving Sleep in BMT Survivors

Developing and Testing an mHealth Stepped-Care Intervention for Sleep Disturbance in HCT Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep Disturbance
• Sleep Disorder

Interventions

Type	Name	Description
OTHER	mHealth Stepped-care Intervention	Test of the feasibility and acceptability of an mHealth stepped-care intervention for sleep disturbance in HCT survivors, to compare with the control group.
OTHER	Educational Control Condition	General health education for cancer survivors provided in NCI booklets entitled Facing Forward: Life After Cancer Treatment and Coping With Advanced Cancer.
OTHER	Questionnaire	After the intervention, participants will be asked to complete a questionnaire to provide feedback on the intervention.
OTHER	Interview	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.
OTHER	Qualitative Interviews	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.
OTHER	Virtual Reality	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).

Timeline

• Start date: 2018-05-15
• Primary completion: 2019-06-29
• Completion: 2024-04-19
• First posted: 2018-05-25
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States