InsomniaSIESTA-PNCT07128927
Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors
A study testing Sleep Healthy Using the Internet (SHUTi) and Patient education in people with Insomnia, run by Georgetown University at 1 site in United States.
Trial summary
This pilot study will recruit Black/African American prostate cancer survivors into a clinical trial and will randomize each person to 1 of 2 possible treatments - an internet-based treatment for insomnia called Sleep Healthy Using the Internet (SHUTi) or an educational website. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Insomnia
- What is being tested?
- Sleep Healthy Using the Internet (SHUTi) and Patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥21 years
- Self-identifies as Black/African American
- Diagnosed with invasive prostate cancer (AJCC stages I-IV) within 5 years
- Has not received surgery, chemotherapy, or radiation within the previous 3 months
- Has a smart phone, tablet, or computer with reliable internet access or willing to attend a weekly study appointment and to complete a weekly phone call
- Has clinically relevant insomnia symptoms (i.e., score ≥10 on the Insomnia Severity Index)
- Able to read and understand English
Who cannot join
- Employed in an occupation where sleep restriction could be a harm to themselves or others
- Actively employed in shift work
- Diagnosed with a severe/major psychiatric disorder
- Diagnosed with a seizure disorder or recently (≤12 months) experienced a seizure
- Unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20003
Traci Bethea, 202-687-5367, siestap@georgetown.edu
Traci Bethea
About this study
This pilot study will recruit Black/African American prostate cancer survivors into a clinical trial and will randomize each person to 1 of 2 possible treatments - an internet-based treatment for insomnia called Sleep Healthy Using the Internet (SHUTi) or an educational website. SHUTi provides the treatment - cognitive behavioral therapy for insomnia - across 6 lessons, while the educational website is like an online patient brochure. The study will examine the feasibility of SHUTi to improve sleep and well-being among Black prostate cancer survivors. It will also examine whether SHUTi is acceptable to these survivors and will compare the effect of SHUTi versus the educational website on insomnia and non-insomnia patient-reported outcomes.
Read the detailed description
Insomnia is a risk factor for poor physical, cognitive, and psychosocial outcomes, including depression, anxiety, frailty, and diminished cognitive function, especially among cancer survivors. Although Cancer treatment, including androgen deprivation therapy, may increase insomnia symptoms and the prevalence of insomnia among prostate cancer survivors is estimated to be 25-39%. Prostate cancer has the highest incidence rate and second highest mortality rate among men in the U.S. with a highest burden of both incidence and mortality among Black men compared to men of other racial/ethnic groups. However, few studies have examined treatment of insomnia in this population. Insomnia is associated with greater symptom burden (i.e., multiple concurrent symptoms, such as depression, anxiety, fatigue, pain, cognition) among prostate cancer survivors, so treating insomnia may provide an opportunity to improve well-being in this population.
Cognitive Behavioral Therapy for Insomnia (CBT-I) has demonstrated substantial and persistent improvements in insomnia severity among cancer survivors such that the National Comprehensive Cancer Network (NCCN) recommends it "as the preferred treatment for insomnia." Trials to develop and test web-based and digital CBT-I interventions have shown non-inferiority to in-person administration by a trained therapist and increase availability of insomnia treatment to more patients. Recent NCCN guidelines note that improving sleep may provide additional benefits by resulting in less fatigue, better mood, better quality of life, and improved survival. However, to date, this accessible and interactive intervention has not been investigated among prostate cancer survivors.
This study uses the Sleep Healthy Using the Internet (SHUTi) program to provide CBT-I via the internet. SHUTi is self-administered and interactive with 6 weekly 45-60 minute sessions delivered over the course of 9 weeks. The program uses sleep diary data provided by each participant to tailor recommendations. Prostate cancer survivors participating in this pilot study will be randomized to receive access to SHUTi or to a patient education website. All participants will complete study visits and data collection, including sleep diaries and questionnaires, at baseline and post-intervention (10-12 weeks later).
- Conditions
- Insomnia
- Being tested
- Sleep Healthy Using the Internet (SHUTi), Patient education
- Keywords
- insomnia, Sleep Healthy Using the Internet (SHUTi), prostate cancer survivorship, cognitive behavioral therapy for 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.
Sleep Healthy Using the Internet (SHUTi)Behavioural
Also called Cognitive behavioral therapy for insomnia, CBT-i
Web-based, self-administered, and interactive cognitive behavioral therapy for insomnia
Patient educationBehavioural
Also called Sleep hygiene
Website that describes insomnia, including factors that may increase or decrease insomnia symptoms, and provides information about addressing insomnia symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Healthy Using the Internet (SHUTi) | Experimental | SHUTi provides 6 sessions of 45-60 minutes in length delivered over the course of 6-9 weeks. The program tailors recommendations based on sleep diary data provided by each participant. Receives: Behavioral: Sleep Healthy Using the Internet (SHUTi) |
| Patient education | Placebo comparator | Static information about insomnia provided on a patient education website Receives: Behavioral: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study protocol
Assessed via:
- the percentage of survivors screened as eligible who consent to participate,
- the percentage of actual vs. planned participants enrolled, and
- the percentage of enrolled participants complete follow-up data collection
Measured: 10-12 weeks
Acceptability of intervention
Assessed via the theoretical framework of acceptability questionnaire (range: 5-35, higher score = greater acceptability)
Measured: 10-12 weeks
Secondary outcomes (1)
Efficacy of intervention
Assessed via change in the Insomnia Severity Index score (range: 0-28, higher score = more insomnia symptoms) from baseline to post-intervention
Measured: 10-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Dec 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128927
- Sponsor's protocol ID
- STUDY00007350
- Acronym
- SIESTA-P
- Status last verified
- Dec 2025
- First submitted
- 5 Aug 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bai P. Application and Mechanisms of Internet-Based Cognitive Behavioral Therapy (iCBT) in Improving Psychological State in Cancer Patients. J Cancer. 2023 Jul 3;14(11):1981-2000. doi: 10.7150/jca.82632. eCollection 2023.
PubMed 37497400Gonzalez BD, Small BJ, Cases MG, Williams NL, Fishman MN, Jacobsen PB, Jim HSL. Sleep disturbance in men receiving androgen deprivation therapy for prostate cancer: The role of hot flashes and nocturia. Cancer. 2018 Feb 1;124(3):499-506. doi: 10.1002/cncr.31024. Epub 2017 Oct 26.
PubMed 29072790Leger P, Frencher S Jr, Nauseef JT, Jones B, Bilen MA, Brown A Jr, Ullah A, McDevitt S, Tsao CK. A multi-perspective study assessing Black and African American participation barriers in prostate cancer clinical trials. Future Oncol. 2025 Apr;21(8):967-973. doi: 10.1080/14796694.2025.2467519. Epub 2025 Feb 24.
PubMed 39992723Ritterband LM, Thorndike FP, Gonder-Frederick LA, Magee JC, Bailey ET, Saylor DK, Morin CM. Efficacy of an Internet-based behavioral intervention for adults with insomnia. Arch Gen Psychiatry. 2009 Jul;66(7):692-8. doi: 10.1001/archgenpsychiatry.2009.66.
PubMed 19581560
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors
- ClinicalTrials.gov ID
- NCT07128927
- Acronym / sponsor ID
- SIESTA-P / STUDY00007350
- Conditions
- Insomnia
- Keywords
- insomnia, Sleep Healthy Using the Internet (SHUTi), prostate cancer survivorship, cognitive behavioral therapy for insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 19 Aug 2025 (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 pilot study will recruit Black/African American prostate cancer survivors into a clinical trial and will randomize each person to 1 of 2 possible treatments - an internet-based treatment for insomnia called Sleep Healthy Using the Internet (SHUTi) or an educational website. SHUTi provides the treatment - cognitive behavioral therapy for insomnia - across 6 lessons, while the educational website is like an online patient brochure. The study will examine the feasibility of SHUTi to improve sleep and well-being among Black prostate cancer survivors. It will also examine whether SHUTi is acceptable to these survivors and will compare the effect of SHUTi versus the educational website on insomnia and non-insomnia patient-reported outcomes.
Detailed description
Insomnia is a risk factor for poor physical, cognitive, and psychosocial outcomes, including depression, anxiety, frailty, and diminished cognitive function, especially among cancer survivors. Although Cancer treatment, including androgen deprivation therapy, may increase insomnia symptoms and the prevalence of insomnia among prostate cancer survivors is estimated to be 25-39%. Prostate cancer has the highest incidence rate and second highest mortality rate among men in the U.S. with a highest burden of both incidence and mortality among Black men compared to men of other racial/ethnic groups. However, few studies have examined treatment of insomnia in this population. Insomnia is associated with greater symptom burden (i.e., multiple concurrent symptoms, such as depression, anxiety, fatigue, pain, cognition) among prostate cancer survivors, so treating insomnia may provide an opportunity to improve well-being in this population.
Cognitive Behavioral Therapy for Insomnia (CBT-I) has demonstrated substantial and persistent improvements in insomnia severity among cancer survivors such that the National Comprehensive Cancer Network (NCCN) recommends it "as the preferred treatment for insomnia." Trials to develop and test web-based and digital CBT-I interventions have shown non-inferiority to in-person administration by a trained therapist and increase availability of insomnia treatment to more patients. Recent NCCN guidelines note that improving sleep may provide additional benefits by resulting in less fatigue, better mood, better quality of life, and improved survival. However, to date, this accessible and interactive intervention has not been investigated among prostate cancer survivors.
This study uses the Sleep Healthy Using the Internet (SHUTi) program to provide CBT-I via the internet. SHUTi is self-administered and interactive with 6 weekly 45-60 minute sessions delivered over the course of 9 weeks. The program uses sleep diary data provided by each participant to tailor recommendations. Prostate cancer survivors participating in this pilot study will be randomized to receive access to SHUTi or to a patient education website. All participants will complete study visits and data collection, including sleep diaries and questionnaires, at baseline and post-intervention (10-12 weeks later).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Healthy Using the Internet (SHUTi) | Experimental | Behavioral: Sleep Healthy Using the Internet (SHUTi)SHUTi provides 6 sessions of 45-60 minutes in length delivered over the course of 6-9 weeks. The program tailors recommendations based on sleep diary data provided by each participant. |
| Patient education | Placebo comparator | Behavioral: Patient educationStatic information about insomnia provided on a patient education website |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥21 years
- Self-identifies as Black/African American
- Diagnosed with invasive prostate cancer (AJCC stages I-IV) within 5 years
- Has not received surgery, chemotherapy, or radiation within the previous 3 months
- Has a smart phone, tablet, or computer with reliable internet access or willing to attend a weekly study appointment and to complete a weekly phone call
Key exclusion criteria (5 listed)
- Employed in an occupation where sleep restriction could be a harm to themselves or others
- Actively employed in shift work
- Diagnosed with a severe/major psychiatric disorder
- Diagnosed with a seizure disorder or recently (≤12 months) experienced a seizure
- Unable to consent
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 |
|---|---|---|
| Sleep Healthy Using the Internet (SHUTi)Also: Cognitive behavioral therapy for insomnia, CBT-iWeb-based, self-administered, and interactive cognitive behavioral therapy for insomnia | Behavioural | Sleep Healthy Using the Internet (SHUTi) |
| Patient educationAlso: Sleep hygieneWebsite that describes insomnia, including factors that may increase or decrease insomnia symptoms, and provides information about addressing insomnia symptoms. | Behavioural | Patient education |
Primary outcome
Feasibility of study protocol
Time frame: 10-12 weeks
Assessed via: * the percentage of survivors screened as eligible who consent to participate, * the percentage of actual vs. planned participants enrolled, and * the percentage of enrolled participants complete follow-up data collection
Acceptability of intervention
Time frame: 10-12 weeks
Assessed via the theoretical framework of acceptability questionnaire (range: 5-35, higher score = greater acceptability)
1 secondary outcome
Efficacy of intervention
Time frame: 10-12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 37497400Bai P. Application and Mechanisms of Internet-Based Cognitive Behavioral Therapy (iCBT) in Improving Psychological State in Cancer Patients. J Cancer. 2023 Jul 3;14(11):1981-2000. doi: 10.7150/jca.82632. eCollection 2023.
- Background: PubMed 29072790Gonzalez BD, Small BJ, Cases MG, Williams NL, Fishman MN, Jacobsen PB, Jim HSL. Sleep disturbance in men receiving androgen deprivation therapy for prostate cancer: The role of hot flashes and nocturia. Cancer. 2018 Feb 1;124(3):499-506. doi: 10.1002/cncr.31024. Epub 2017 Oct 26.
- Background: PubMed 39992723Leger P, Frencher S Jr, Nauseef JT, Jones B, Bilen MA, Brown A Jr, Ullah A, McDevitt S, Tsao CK. A multi-perspective study assessing Black and African American participation barriers in prostate cancer clinical trials. Future Oncol. 2025 Apr;21(8):967-973. doi: 10.1080/14796694.2025.2467519. Epub 2025 Feb 24.
- Background: PubMed 19581560Ritterband LM, Thorndike FP, Gonder-Frederick LA, Magee JC, Bailey ET, Saylor DK, Morin CM. Efficacy of an Internet-based behavioral intervention for adults with insomnia. Arch Gen Psychiatry. 2009 Jul;66(7):692-8. doi: 10.1001/archgenpsychiatry.2009.66.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Healthy Using the Internet (SHUTi) and Patient education in people with Insomnia, run by Georgetown University 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Traci Bethea (202-687-5367, siestap@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study protocol (time frame: 10-12 weeks). The study lists 2 primary outcomes in all. 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 NCT07128927, which also lists 4 linked publications.
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 26 Oct 2026.