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Cognitive Behavioral Therapy for Insomnia in Childhood Cancer Survivors

N/A
Recruiting
Led By Tara Brinkman, PhD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between the ages of 18 and 65 years old
Clinically significant insomnia (i.e. score >15 on the Insomnia Severity Index)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post-intervention follow up (approximately 10 weeks after baseline)]
Awards & highlights

Study Summary

This trial will use an accepted, established, efficacious internet-delivered CBTi insomnia treatment program to evaluate the efficacy of this program in adult survivors of childhood cancer.

Who is the study for?
This trial is for adult survivors of childhood cancer aged 18-65 who are enrolled in the CCSS, have regular internet access, and can read and speak English. Participants must have significant insomnia and some neurocognitive impairment but not be currently pregnant or breastfeeding, nor have a history of brain tumors, psychotic disorders, other sleep disorders like apnea or restless leg syndrome, recent substance abuse issues, or irregular schedules that conflict with treatment.Check my eligibility
What is being tested?
The study tests an eHealth intervention called SHUTi to improve insomnia symptoms against an online patient education control group. It aims to see if treating insomnia helps with neurocognitive function and overall quality of life among these survivors. The impact on emotional distress and cardiovascular health will also be explored.See study design
What are the potential side effects?
As this is a non-pharmacological intervention focusing on cognitive behavioral therapy delivered via the internet (CBTi), typical medication side effects are not expected. However, participants may experience temporary increases in anxiety or stress as they adjust to new sleep patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have severe insomnia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post-intervention follow up (approximately 10 weeks after baseline)]
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-intervention follow up (approximately 10 weeks after baseline)] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Insomnia Severity Index (ISI) scores from Baseline to Post-Intervention (approximately 10 weeks after Baseline)
Secondary outcome measures
Change in Childhood Cancer Survivor Study-Neurocognitive questionnaire (CCSS-NCQ) scores from Baseline to Post-Intervention (approximately 10 weeks after Baseline)
Change in Generalized Anxiety Disorder-7 (GAD-7) scores from Baseline to Post-Intervention (approximately 6 months after Baseline)
Change in Patient Health Questionnaire (PHQ-9) scores from Baseline to Post-Intervention (approximately 6 months after Baseline)
+3 more

Trial Design

2Treatment groups
Active Control
Group I: Sleep Healthy Using the Internet (SHUTi) Intervention GroupActive Control1 Intervention
Participants will receive a direct link to access the SHUTi program (per randomization) from the study team.
Group II: Online Patient Education (PE) Control GroupActive Control1 Intervention
Participants will receive a direct link to access online patient education (per randomization) from the study team.

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
427 Previous Clinical Trials
5,306,225 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,995 Total Patients Enrolled
10 Trials studying Insomnia
1,643 Patients Enrolled for Insomnia
Tara Brinkman, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital
3 Previous Clinical Trials
1,163 Total Patients Enrolled

Media Library

Sleep Healthy Using the Internet (SHUTi) Intervention Group Clinical Trial Eligibility Overview. Trial Name: NCT04317742 — N/A
Insomnia Research Study Groups: Sleep Healthy Using the Internet (SHUTi) Intervention Group, Online Patient Education (PE) Control Group
Insomnia Clinical Trial 2023: Sleep Healthy Using the Internet (SHUTi) Intervention Group Highlights & Side Effects. Trial Name: NCT04317742 — N/A
Sleep Healthy Using the Internet (SHUTi) Intervention Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT04317742 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being observed as part of this research project?

"Indeed, the clinicaltrials.gov database states that this trial is still recruiting patients and has been since November 1st 2022. The most recent update to its information was on September 27th of the same year. Currently, 352 individuals must be sourced from a single site for participation in the study."

Answered by AI

Are seniors eligible for participation in this clinical exploration?

"According to the study prerequisites, individuals aged 18-65 can qualify for this trial. There are 77 trials available specifically for minors and 301 additional studies reserved for elderly applicants."

Answered by AI

Is it feasible for me to sign up as a participant in this research experiment?

"This clinical trial is seeking 352 candidates with sleep issues aged 18 to 65. To be eligible, patients must sign up for the CCSS program and have a clinically significant insomnia rating (ISI >15) as well as neurocognitive impairment score exceeding 84th percentile of sibling normative data on the CCSS-NCQ test. Furthermore, an internet connection at least 2 or 3 days per week is obligatory."

Answered by AI

Are there any opportunities to join this clinical trial currently open?

"According to the clinicaltrials.gov database, this experiment is actively recruiting individuals and was originally made public on November 1st 2022 before being updated lastly on September 27th of that same year."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
~25 spots leftby Jun 2024