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Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors

Primary Purpose

Insomnia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SHUTi

About this trial

This is an interventional supportive care trial for Insomnia focused on measuring Insomnia

Eligibility Criteria

14 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

14-25 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

Exclusion Criteria:

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

Sites / Locations

Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHUTi

Arm Description

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

Outcomes

Primary Outcome Measures

Insomnia symptoms

Insomnia symptom severity will be assessed using the Insomnia Severity Index

Secondary Outcome Measures

Sleep efficiency

Sleep diary calculated sleep efficiency

Quality of life

Measured with PedsQL

Daytime sleepiness

Measured with Pediatric Daytime Sleepiness Scale

Full Information

NCT ID

NCT03279055

First Posted

September 9, 2017

Last Updated

October 27, 2020

Sponsor

Dana-Farber Cancer Institute

Collaborators

Alex's Lemonade Stand Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03279055

Brief Title

Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors

Official Title

Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

August 10, 2018 (Actual)

Primary Completion Date

December 20, 2019 (Actual)

Study Completion Date

December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Alex's Lemonade Stand Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The purpose of this study is to learn whether an adapted version of SHUTi (Sleep Healthy Using the Internet), a six-session online program which has been found to be effective in other groups of people, will be useful in treating insomnia in adolescent and young adult cancer survivors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia

Keywords

Insomnia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SHUTi

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

SHUTi

Intervention Description

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.

Primary Outcome Measure Information:

Title

Insomnia symptoms

Description

Insomnia symptom severity will be assessed using the Insomnia Severity Index

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Sleep efficiency

Description

Sleep diary calculated sleep efficiency

Time Frame

6 weeks

Title

Quality of life

Description

Measured with PedsQL

Time Frame

8 weeks

Title

Daytime sleepiness

Description

Measured with Pediatric Daytime Sleepiness Scale

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 14-25 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Zhou, PhD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32568460

Citation

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.

Results Reference

result

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Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors

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