InsomniaNCT03279055
Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors
A study testing SHUTi in people with Insomnia, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Insomnia
- What is being tested?
- SHUTi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2018to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- SHUTi
- Keywords
- Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHUTiBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: SHUTi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia symptoms
Insomnia symptom severity will be assessed using the Insomnia Severity Index
Measured: 8 weeks
Secondary outcomes (3)
Sleep efficiency
Sleep diary calculated sleep efficiency
Measured: 6 weeks
Quality of life
Measured with PedsQL
Measured: 8 weeks
Daytime sleepiness
Measured with Pediatric Daytime Sleepiness Scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start10 Aug 2018
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Alex's Lemonade Stand Foundation
- Responsible party
- Principal investigator, Eric Zhou, Dana-Farber Cancer Institute
- Investigators
- Eric Zhou, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279055
- Sponsor's protocol ID
- 17-276
- Status last verified
- Oct 2020
- First submitted
- 9 Sep 2017
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32568460
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT03279055
- Acronym / sponsor ID
- 17-276
- Conditions
- Insomnia
- Keywords
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Alex's Lemonade Stand Foundation
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHUTi | Experimental | Behavioral: SHUTi* 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 |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHUTiSleep 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. | Behavioural | SHUTi |
Primary outcome
Insomnia symptoms
Time frame: 8 weeks
Insomnia symptom severity will be assessed using the Insomnia Severity Index
3 secondary outcomes
Sleep efficiency
Time frame: 6 weeks
Quality of life
Time frame: 8 weeks
Daytime sleepiness
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Results publication: PubMed 32568460Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Zhou, PhD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHUTi in people with Insomnia, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia symptoms (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.