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Clinical Trial 19486

Cancer Type:
Interventions:

Study Type: Supportive Care
Phase of Study: N/A
Investigators:

  • Brian Gonzalez

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

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

Summary

The purposes of this study are to: 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. To test a new intervention for sleep disturbance among hematopoietic cell transplant survivors.

Objective

Aim 1: 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. Aim 2: To develop a new mHealth intervention to reduce cancer-related sleep disturbance in HCT recipients after discharge. Aim 3: To test the new mHealth stepped care intervention. Aim 3.a: To test the feasibility and acceptability of an mHealth stepped-care intervention for sleep disturbance in HCT survivors. Aim 3.b: To examine participants' perceptions of the new intervention and examine what percentage of intervention group participants' sleep improves significantly after receipt of the brief behavioral therapy vs. the more intensive cognitive-behavioral therapy. Aim 3.c: To examine the preliminary efficacy of an mHealth stepped-care intervention for reducing sleep disturbance in HCT survivors.

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