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Improving Sleep in BMT Survivors

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ClinicalTrials.gov Identifier: NCT03537963
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : August 18, 2020
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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.


Condition or disease Intervention/treatment Phase
Sleep Disturbance Sleep Disorder Other: mHealth Stepped-care Intervention Other: Educational Control Condition Other: Questionnaire Other: Interview Other: Qualitative Interviews Other: Virtual Reality Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Developing and Testing an mHealth Stepped-Care Intervention for Sleep Disturbance in HCT Survivors
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Pre-Intervention Qualitative Interviews
Hematopoietic cell transplant (HCT) survivors, caregivers and clinicians will participate in this part of the study. HCT survivor 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. All participants will be asked to participate in either an in-person or telephone interview that will last approximately 1 hour. The interview will be digitally audio-recorded and will ask questions on the trajectory of sleep disturbance in HCT recipients and strategies to manage common barriers to quality sleep, as well as discuss the planned intervention for sleep disturbance in HCT survivors.
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 Name: Questionnaire

Experimental: mHealth Stepped-care Intervention
For HCT survivors randomized to this group: Baseline survey, followed by mHealth Stepped-care intervention, post-intervention questionnaire and interview.
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: 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.

Active Comparator: Educational Control Condition
For HCT survivors randomized to this group: Baseline survey, followed by Educational Control intervention, post-intervention questionnaire and interview.
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.

Experimental: mHealth Stepped-care Intervention + virtual reality relaxation
For HCT survivors randomized to this group: Baseline survey, followed by mHealth Stepped-care intervention + virtual reality relaxation component, post-intervention questionnaire and interview.
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: 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: 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).
Other Name: VR




Primary Outcome Measures :
  1. Rate of Participant Completion of Study [ Time Frame: Up to 60 days ]
    The study will be considered feasible if 70% of those who participate complete the intervention.

  2. Rate of Participant Satisfaction [ Time Frame: 60 days post intervention ]
    The study will be considered acceptable if 50% of eligible patients approached for study participation sign consent and if > 50% of the mHealth stepped-care intervention group participants report that they are at least "mostly satisfied" with the intervention on a validated satisfaction scale. That is, at least half report an average score of ≥ 3 on a scale of 1 to 4 on this instrument.


Secondary Outcome Measures :
  1. Rate of Sleep Disturbance [ Time Frame: 60 days post intervention ]
    Sleep disturbance will be operationalized by scores on the Pittsburgh Sleep Quality Index and sleep efficiency (the percentage of time spent in bed that is spent asleep). For secondary efficacy analyses participants will be categorized as having sleep disturbance if their Pittsburgh Sleep Quality Index score is ≥ 5 (for subjectively-measured sleep disturbance) and if their sleep efficiency is <85% (for objectively-measured sleep disturbance).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537963


Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Yvelise Rodriguez    813-745-1814    yvelise.rodriguez@moffitt.org   
Principal Investigator: Brian Gonzalez, Ph.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
American Cancer Society, Inc.
Investigators
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Principal Investigator: Brian Gonzalez, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03537963    
Other Study ID Numbers: MCC-19486
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
HCT survivors
hematopoietic stem cell transplant (HCT)
survivors of hematopoietic stem cell transplant
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders