NCT03279055

Brief Summary

This research study is evaluating a six-session online program designed to help insomnia (difficulty falling or staying asleep) in adolescent and young adult cancer survivors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

August 10, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

September 9, 2017

Last Update Submit

October 27, 2020

Conditions

Insomnia

Keywords

Insomnia

Outcome Measures

Primary Outcomes (1)

  • Insomnia symptoms

    Insomnia symptom severity will be assessed using the Insomnia Severity Index

    8 weeks

Secondary Outcomes (3)

  • Sleep efficiency

    6 weeks

  • Quality of life

    8 weeks

  • Daytime sleepiness

    8 weeks

Study Arms (1)

SHUTi

EXPERIMENTAL

* Participants will be provided with an individual access code for SHUTi * SHUTi is delivered over 6 sessions, each taking 20-30 minutes * SHUTi is delivered by a virtual therapist * Participants will learn about the etiology and maintenance of their insomnia * Participants will learn how to maintain their sleep log * Participants will learn how to address lifestyle barriers that impact their sleep * Participants will be taught stimulus control techniques targeting non-sleep behaviors in the bedroom * Participants will learn a range of cognitive techniques that address the key cognitive factors that perpetuate poor sleep behavior * Participants will be taught how to gradually expand their restricted sleep

Behavioral: SHUTi

Interventions

SHUTiBEHAVIORAL

Sleep Healthy Using the Internet (SHUTi) is a publicly available insomnia intervention program. It focuses on 5 treatment components that form the core of CBT-I: sleep restriction, stimulus control, cognitive restructuring, sleep behaviors, and relapse prevention.

SHUTi

Eligibility Criteria

Age14 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age
  • History of a cancer diagnosis
  • No active cancer therapy (excluding chemoprevention) in the past three months, and no cancer therapy currently planned in the next 6 months
  • No surgery planned in the next 6 months
  • Significant insomnia as evidenced by an Insomnia Severity Index score ≥12
  • Able to read and write in English
  • Has internet access at home
  • Motivated and able to follow the demands of the SHUTi program, to keep sleep records, complete self-report symptom reports and make changes in their sleep schedule, including restricting their sleep

You may not qualify if:

  • Prior attempt(s) to treat insomnia using cognitive-behavioral treatment for insomnia
  • History of Bipolar Disorder diagnosis
  • History of a Seizure Disorder diagnosis or have experienced a seizure in the past 12 months
  • Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter (e.g., Benadryl, Unisom) medications that can affect sleep during the study period
  • Diagnosed, untreated sleep apnea or sleep apnea suspected by a physician but which has not been unevaluated, or other sleep disorder
  • Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery)
  • Refusal to modify or reduce excessive alcohol use that is likely to interfere with an individual's sleep

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Zhou ES, Recklitis CJ. Internet-delivered insomnia intervention improves sleep and quality of life for adolescent and young adult cancer survivors. Pediatr Blood Cancer. 2020 Sep;67(9):e28506. doi: 10.1002/pbc.28506. Epub 2020 Jun 22.

    PMID: 32568460RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Eric Zhou, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eric Zhou, PhD

Study Record Dates

First Submitted

September 9, 2017

First Posted

September 12, 2017

Study Start

August 10, 2018

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)