Chronic InsomniaNCT03810365
Brief Behavioral Treatment for Insomnia in Cancer Survivors
A study testing Brief behavioral treatment for insomnia in people with Chronic Insomnia, run by State University of New York at Buffalo at 2 sites in United States.
Trial summary
The purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Brief behavioral treatment for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jun 2019to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > or = 4 weeks from surgery for cancer treatment; chemotherapy and/or radiation therapy; no wait for hormone therapy or targeted treatment for stage I, II, or III: breast, colorectal, prostate, lung cancer
- chronic insomnia
Who cannot join
- Other preexisting sleep disorders except those with OSA stable on CPAP
- Unstable medical illnesses
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University at Buffalo
Buffalo, New York, 14214
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
About this study
Official title: Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors
The purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.
Read the detailed description
A randomized controlled clinical trial will be used to test the efficacy of this brief behavioral treatment compared to attention control on sleep, mood, functional, status and quality of life and determine predictors for efficacy of Brief Behavioral Treatment for Insomnia (BBTI).
- Conditions
- Chronic Insomnia
- Being tested
- Brief behavioral treatment for insomnia, Healthy Eating Control
- Keywords
- Cancer Survivors, Brief Behavioral Treatment, Older Adults, Attention Control, Intervention
- 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.
Brief behavioral treatment for insomniaBehavioural
Brief Behavioral Treatment for Insomnia includes content on sleep restriction, stimulus control, and sleep hygiene content with 1 month for primary outcome followed by 3 month 12 month follow-up visits.
Healthy Eating ControlBehavioural
Healthy eating control involves healthy eating content with 1 month for primary outcome followed by 3 month and 12 month follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: Brief behavioral treatment for insomnia | Experimental | Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls. Receives: Behavioral: Brief behavioral treatment for insomnia |
| Behavioral: Healthy eating control | Active comparator | Healthy eating control involves a 45 minute individual session with two follow up phone calls. Receives: Behavioral: Healthy Eating Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
One month after the intervention, experimental group mean for Insomnia Severity Index will be compared to control group mean Insomnia Severity Index.
The Insomnia Severity Index is a self report brief screening tool with seven items that asks respondents to rate the nature and symptoms of their sleep problems and the degree to which insomnia interferes with daily functioning and overall distress created by sleep problems using a likert type scale Scores between 0-7 have no clinically significant insomnia. Scores between 8-14 have sub threshold insomnia. Scores between 15-21 have moderate clinical insomnia. Scores between 22-28 have severe clinical insomnia.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start6 Jun 2019
- Primary completion17 Nov 2022
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Roswell Park Cancer Institute, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Suzanne Dickerson, State University of New York at Buffalo
- Investigators
- Suzanne S. Dickerson, PhD, Principal investigator, University at Buffalo, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810365
- Sponsor's protocol ID
- STUDY00002898
- Other IDs
- 1R01NR018215
- Status last verified
- Jun 2024
- First submitted
- 14 Jan 2019
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
PubMed 41170811Kwon M, Zhu J, Wilding GE, Larkin K, Gehrman PR, Dickerson SS. Health-related quality of life and mental health outcomes among cancer survivors in an insomnia intervention: a randomized controlled trial. Ann Behav Med. 2025 Jan 4;59(1):kaae096. doi: 10.1093/abm/kaae096.
PubMed 39887070Dickerson SS, Kwon M, Wilding GE, Zhu J. Nurse-delivered brief behavioral treatment for insomnia in cancer survivors: a randomized controlled trial. J Cancer Surviv. 2026 Jun;20(3):1010-1022. doi: 10.1007/s11764-024-01704-1. Epub 2024 Nov 26.
PubMed 39589721Kwon M, Zhu J, Wilding GE, Dickerson SS, Dean GE. Sleep-wake state discrepancy among cancer survivors with insomnia symptoms. Support Care Cancer. 2023 Dec 4;32(1):2. doi: 10.1007/s00520-023-08177-5.
PubMed 38047967Kwon M, Dickerson SS, Wilding GE, Aquilina AT, Reid M, Dean GE. A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. Contemp Clin Trials. 2022 Nov;122:106939. doi: 10.1016/j.cct.2022.106939. Epub 2022 Sep 28.
PubMed 36182027
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors
- ClinicalTrials.gov ID
- NCT03810365
- Acronym / sponsor ID
- STUDY00002898
- Conditions
- Chronic Insomnia
- Keywords
- Cancer Survivors, Brief Behavioral Treatment, Older Adults, Attention Control, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Roswell Park Cancer Institute, National Institute of Nursing Research (NINR)
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Posted 30 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.
Detailed description
A randomized controlled clinical trial will be used to test the efficacy of this brief behavioral treatment compared to attention control on sleep, mood, functional, status and quality of life and determine predictors for efficacy of Brief Behavioral Treatment for Insomnia (BBTI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Brief behavioral treatment for insomnia | Experimental | Behavioral: Brief behavioral treatment for insomniaBrief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls. |
| Behavioral: Healthy eating control | Active comparator | Behavioral: Healthy Eating ControlHealthy eating control involves a 45 minute individual session with two follow up phone calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > or = 4 weeks from surgery for cancer treatment; chemotherapy and/or radiation therapy; no wait for hormone therapy or targeted treatment for stage I, II, or III: breast, colorectal, prostate, lung cancer
- chronic insomnia
Key exclusion criteria (2 listed)
- Other preexisting sleep disorders except those with OSA stable on CPAP
- Unstable medical illnesses
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 |
|---|---|---|
| Brief behavioral treatment for insomniaBrief Behavioral Treatment for Insomnia includes content on sleep restriction, stimulus control, and sleep hygiene content with 1 month for primary outcome followed by 3 month 12 month follow-up visits. | Behavioural | Behavioral: Brief behavioral treatment for insomnia |
| Healthy Eating ControlHealthy eating control involves healthy eating content with 1 month for primary outcome followed by 3 month and 12 month follow-up visits. | Behavioural | Behavioral: Healthy eating control |
Primary outcome
Insomnia Severity Index
Time frame: one month
One month after the intervention, experimental group mean for Insomnia Severity Index will be compared to control group mean Insomnia Severity Index. The Insomnia Severity Index is a self report brief screening tool with seven items that asks respondents to rate the nature and symptoms of their sleep problems and the degree to which insomnia interferes with daily functioning and overall distress created by sleep problems using a likert type scale Scores between 0-7 have no clinically significant insomnia. Scores between 8-14 have sub threshold insomnia. Scores between 15-21 have moderate clinical insomnia. Scores between 22-28 have severe clinical insomnia.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41170811Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
- Derived from this study: PubMed 39887070Kwon M, Zhu J, Wilding GE, Larkin K, Gehrman PR, Dickerson SS. Health-related quality of life and mental health outcomes among cancer survivors in an insomnia intervention: a randomized controlled trial. Ann Behav Med. 2025 Jan 4;59(1):kaae096. doi: 10.1093/abm/kaae096.
- Derived from this study: PubMed 39589721Dickerson SS, Kwon M, Wilding GE, Zhu J. Nurse-delivered brief behavioral treatment for insomnia in cancer survivors: a randomized controlled trial. J Cancer Surviv. 2026 Jun;20(3):1010-1022. doi: 10.1007/s11764-024-01704-1. Epub 2024 Nov 26.
- Derived from this study: PubMed 38047967Kwon M, Zhu J, Wilding GE, Dickerson SS, Dean GE. Sleep-wake state discrepancy among cancer survivors with insomnia symptoms. Support Care Cancer. 2023 Dec 4;32(1):2. doi: 10.1007/s00520-023-08177-5.
- Derived from this study: PubMed 36182027Kwon M, Dickerson SS, Wilding GE, Aquilina AT, Reid M, Dean GE. A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial. Contemp Clin Trials. 2022 Nov;122:106939. doi: 10.1016/j.cct.2022.106939. Epub 2022 Sep 28.
- Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial.Link provided by the sponsor.
- A primary care "friendly" cognitive behavioral insomnia therapy.Link provided by the sponsor.
- Effects of a brief behavioral treatment for PTSD-related sleep disturbances: a pilot study.Link provided by the sponsor.
- Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer.Link provided by the sponsor.
- How to provide insomnia interventions to people with cancer: insights from patients.Link provided by the sponsor.
- 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.
Suzanne S. Dickerson, PhD principal investigator
University at Buffalo, School of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief behavioral treatment for insomnia in people with Chronic Insomnia, run by State University of New York at Buffalo at 2 sites 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 2 inclusion and 2 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 30 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Severity Index (time frame: one month). 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 NCT03810365, which also lists 5 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 3 Jul 2024.