Improving Sleep in BMT Survivors

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.

Conditions

• Sleep Disturbance
• Sleep Disorder

Interventions

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).

Sponsors & Collaborators

• American Cancer Society, Inc.

  collaborator OTHER

• H. Lee Moffitt Cancer Center and Research Institute

  lead OTHER

Principal Investigators

• Brian Gonzalez, Ph.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-05-15

Primary Completion

2019-06-29

Completion

2024-04-19

Countries

• United States

Study Locations