Cognitive Behavioral Therapy for Insomnia in Childhood Cancer Survivors

Overseen By Tara Brinkman, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Must not be taking: Stimulants

Disqualifiers: Brain tumor, Schizophrenia, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 9 weeks

352 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if an online program called SHUTi (Internet-Delivered Cognitive Behavioral Therapy for Insomnia) can improve sleep problems in adults who survived childhood cancer. Many of these survivors experience insomnia, which affects their thinking, mood, and heart health. Participants will either use the SHUTi program or receive online education, and the study will compare the outcomes. Ideal participants have significant sleep issues and some cognitive challenges, with internet access a few days a week. As an unphased trial, this study offers a unique opportunity for participants to potentially enhance their sleep and overall well-being through innovative online therapy.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently receiving treatment for cognitive impairment, such as stimulant medication, you would not be eligible to participate.

What prior data suggests that this internet-delivered CBTi program is safe for childhood cancer survivors?

Research has shown that online cognitive behavioral therapy for insomnia (CBTi) is generally safe for adults, including those with a history of cancer. In past studies, the Sleep Healthy Using the Internet (SHUTi) program improved sleep quality, helping people sleep better and fall asleep faster. Participants also reported feeling more refreshed upon waking.

These studies reported no major negative effects from using SHUTi, suggesting that most people tolerate the treatment well. However, individual experiences can vary, so consulting a healthcare provider before starting any new treatment is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Sleep Healthy Using the Internet" (SHUTi) program for insomnia in childhood cancer survivors because it offers an innovative, web-based approach that differs from traditional treatments like medications or in-person therapy sessions. SHUTi delivers cognitive behavioral therapy for insomnia (CBT-I) entirely online, making it more accessible and convenient for users who might face challenges attending regular therapy sessions. This digital delivery method allows for personalized pacing and interaction, which could enhance engagement and adherence compared to standard care options.

What evidence suggests that the SHUTi intervention is effective for improving insomnia in childhood cancer survivors?

Research shows that online cognitive behavioral therapy for insomnia (CBT-i) effectively helps adult cancer survivors sleep better. In this trial, participants in the Sleep Healthy Using the Internet (SHUTi) Intervention Group will access the SHUTi program, which has proven to improve sleep quality, shorten the time to fall asleep, and increase morning refreshment. Studies also show significant improvements in insomnia severity, reduced daytime tiredness, and enhanced quality of life. Although most research has focused on adults, these positive results suggest potential benefits for childhood cancer survivors as well. Overall, SHUTi's online format offers easy access and may improve sleep in this group. ^{1 2 6 7 8}

Who Is on the Research Team?

Tara Brinkman, PHD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Regular access to the internet (at least 2-3 days per week)

Enrollment in CCSS

Neurocognitive impairment (i.e. score >84th %ile of sibling normative data in at least one domain on the CCSS-NCQ)

Exclusion Criteria

I have received therapy for insomnia in the last year.

An irregular schedule that would prevent adoption of intervention strategies (i.e. work schedule resulting in usual bedtime earlier than 8 PM or later than 2 AM or arising time earlier than 4 AM or later than 10 AM)

I have had a brain tumor in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a 9-week internet-based insomnia treatment program (SHUTi) or receive sleep education

9 weeks

Home-based assessments at baseline, post-intervention, and 6 months

Follow-up

Participants are monitored for changes in insomnia symptoms, neurocognitive function, and quality of life

6 months

Home visits for assessments at each time point

What Are the Treatments Tested in This Trial?

Interventions

• Online Patient Education (PE) Control Group
• Sleep Healthy Using the Internet (SHUTi) Intervention Group

Trial Overview 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.

How Is the Trial Designed?

Group I: Sleep Healthy Using the Internet (SHUTi) Intervention Group Active Control 1 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 Group Active Control 1 Intervention

Participants will receive a direct link to access online patient education (per randomization) from the study team.

Sleep Healthy Using the Internet (SHUTi) Intervention Group is already approved in United States for the following indications:

Approved in United States as SHUTi for:

• Insomnia in adult survivors of childhood cancer

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A pilot study involving 38 cancer survivors showed that a brief, group-based cognitive-behavioral therapy for insomnia (CBT-Insomnia) program significantly improved sleep efficiency, quality, and insomnia symptoms after just three sessions over one month.

Despite experiencing insomnia symptoms for an average of 2.4 years, many survivors had not discussed their sleep issues with healthcare providers, highlighting the need for increased awareness and access to insomnia treatments in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Zhou, ES., Partridge, AH., Recklitis, CJ.[2022]

The SHUTi (Sleep Healthy Using The Internet) program, an interactive online intervention for insomnia, was rated highly by participants for its convenience and usefulness, with 95% reporting improvements in sleep and quality of life.

In a small sample of 21 participants, 90% perceived SHUTi as effective, suggesting that Internet-based cognitive-behavioral therapy could be a promising solution to address the lack of access to trained clinicians for insomnia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. Thorndike, FP., Saylor, DK., Bailey, ET., et al.[2022]

This clinical trial involves 625 adults with hypertension and insomnia, comparing the efficacy of two cognitive behavioral treatments for insomnia (BBTI and SHUTi) against enhanced usual care over a period of 12 months.

The study aims to assess not only sleep disturbances but also the impact of these treatments on comorbid conditions like blood pressure and quality of life, potentially influencing real-world treatment delivery for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial. Levenson, JC., Rollman, BL., Ritterband, LM., et al.[2019]

The Survivorship Sleep Program (SSP), a synchronous virtual cognitive behavioral therapy for insomnia (CBT-I) tailored for cancer survivors, demonstrated high feasibility and acceptability, with 90% retention and 100% attendance among participants.

The SSP led to significant reductions in insomnia severity compared to enhanced usual care, with a large effect size (Cohen d = 1.19) that was maintained at a 1-month follow-up, indicating its potential effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. Hall, DL., Arditte Hall, KA., Gorman, MJ., et al.[2023]

Internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) significantly improved sleep outcomes in 255 breast cancer survivors with clinically significant sleep disturbances, showing a strong effect on insomnia severity (Cohen's d = 1.17).

The benefits of iCBT-I were not only immediate but also sustained at follow-up, indicating its potential as a low-cost and effective treatment option that could be integrated into cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. Zachariae, R., Amidi, A., Damholdt, MF., et al.[2023]

An Internet-delivered cognitive-behavioral therapy for insomnia (CBT-I) program tailored for adolescent and young adult (AYA) cancer survivors showed significant improvements in insomnia severity, daytime sleepiness, fatigue, and quality of life after 8 and 16 weeks, indicating its efficacy for this population.

Despite the positive outcomes, only 27.3% of participants completed all six sessions of the program, suggesting a need for strategies to enhance treatment adherence among AYA cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered insomnia intervention improves sleep and quality of life for adolescent and young adult cancer survivors. Zhou, ES., Recklitis, CJ.[2020]

Adolescents and young adults who survived childhood cancer experience high rates of insomnia (26-29%), which negatively affects their quality of life and overall health, highlighting the need for effective treatments.

The study aims to evaluate the effectiveness of a guided online cognitive behavioral therapy for insomnia (iCBT-I) specifically designed for this population, with a randomized controlled trial involving 70 participants to assess improvements in sleep and related health outcomes over 3, 6, and 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the guided online cognitive behavioral therapy for insomnia "i-Sleep youth" improve sleep of adolescents and young adults with insomnia after childhood cancer? (MICADO-study): study protocol of a randomized controlled trial. Peersmann, SHM., van Straten, A., Kaspers, GJL., et al.[2021]

The unguided Internet-based cognitive-behavioral treatment program for insomnia (SHUTi) significantly improved sleep outcomes in 181 participants over a nine-week period, outperforming a web-based patient education group.

Improvements in insomnia severity were maintained at a six-month follow-up for those who completed the SHUTi program, suggesting its potential as a first-line treatment option, although high dropout rates may affect the overall applicability of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Short-Term Efficacy of an Unguided Internet-Based Cognitive-Behavioral Therapy for Insomnia: A Randomized Controlled Trial With a Six-Month Nonrandomized Follow-Up. Hagatun, S., Vedaa, Ø., Nordgreen, T., et al.[2022]

A study involving 23 adults with asthma and insomnia showed that an Internet-based cognitive-behavioral therapy program (SHUTi) was feasible and well-accepted, with 83% completing the program.

Participants reported significant improvements in insomnia severity, sleep quality, asthma control, and asthma-related quality of life after using SHUTi, indicating its potential as an effective treatment for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based Cognitive-Behavioral Therapy for Insomnia in Adults With Asthma: A Pilot Study. Luyster, FS., Ritterband, LM., Sereika, SM., et al.[2021]

In a study of 303 participants, an online cognitive behavioral therapy intervention for insomnia (SHUTi) significantly improved insomnia knowledge and reduced dysfunctional beliefs about sleep, which were linked to better long-term sleep outcomes after 12 months.

The changes in cognitive variables, such as insomnia knowledge and beliefs about sleep, were found to mediate the effectiveness of the SHUTi intervention, suggesting that addressing these cognitive factors is crucial for achieving lasting improvements in sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia. Chow, PI., Ingersoll, KS., Thorndike, FP., et al.[2019]

Citations

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The effect of online cognitive behavioral therapy for ... iCBT‐i in adult cancer survivors is effective in treating insomnia and reducing fatigue, similar to the results of two studies among adolescent and young adult ...

2. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=2678268

Sleep Healthy Using the Internet (SHUTi) The study showed increases in sleep efficiency, soundness of sleep, and feeling refreshed upon awakening and decreases in sleep onset latency, ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pbc.28506

Internet‐delivered insomnia intervention improves sleep ... Significant improvements in insomnia severity, daytime sleepiness, fatigue, and quality of life were reported at both follow up timepoints.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8077706/

Does the guided online cognitive behavioral therapy for ... i-Sleep is shown effective in adult (breast cancer) patients, but it is unknown if iCBT-I is effective in pediatric oncology.

5. ericzhouphd.com ericzhouphd.com/uploads/1/6/6/5/16652960/pediatric_blood_and_cancer_2020.pdf

delivered insomnia intervention improves sleep and quality of ... One such program is SHUTi (sleep healthy using the internet), which improves insomnia and other health out- comes across a wide range of healthy ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00716872

Improving the Sleep of Cancer Patients Using an Internet- ... The purpose of this study is to test the feasibility of using an Internet program to improve the sleep of cancer patients with insomnia. Participants will ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-01162

An eHealth Insomnia Intervention (SHUTi) for the ... This trial studies how well an electronic (e)Health intervention, Sleep Healthy Using the Internet (SHUTi) works in improving symptoms of insomnia in adult ...

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/abs/10.1002/cncr.35796

The effect of online cognitive behavioral therapy for insomnia ... Conclusions. iSleep youth is effective in treating insomnia and concurrent fatigue in adolescents and young adults after childhood cancer and ...