Cancer SurvivorsNCT05519982
Sleep Treatment Education Program-1 (STEP-1)
A study testing Sleep Treatment Education Program (STEP-1) in people with Cancer Survivors and Insomnia, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of the study is to learn if single session online education programs can help improve cancer survivors' sleep. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Cancer Survivors, Insomnia
- What is being tested?
- Sleep Treatment Education Program (STEP-1)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2023to 11 Oct 2024
- 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 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-89
- History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior
- No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned
- Significant insomnia as evidenced by an Insomnia Severity Index score ≥12
- Regular access to the internet on a daily basis
- Able to read and write in English
Who cannot join
- Survivors who report ever being diagnosed with Bipolar Disorder.
- Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months.
- Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia during the study period.
- Survivors diagnosed with sleep apnea who have declined treatment or are not adherent with treatment (as assessed by screening questions, see Appendix A).
- Survivors with suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A).
- Usual bedtime does not fall between 5:00 pm and 5:00 am.
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- Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel across time zones, or employment in a position that could impact public safety (such as air traffic-controller, operating heavy machinery)
- Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.
- Prior participation in a research study which provided an educational or behavioral intervention for insomnia.
- Prior participation in a behavioral treatment or patient education program for insomnia delivered at the Dana-Farber Cancer Institute, or at Boston Children's Hospital.
- Participation in behavioral or educational interventions for insomnia in the 2 years prior to enrollment. This includes in-person as well as synchronous and asynchronous online insomnia programs, but not independent use of books, workbooks or other written self-help materials addressing insomnia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Sleep Treatment Education Program (STEP-1): An Online Educational Intervention for Insomnia in Cancer Survivors
The purpose of the study is to learn if single session online education programs can help improve cancer survivors' sleep.
Read the detailed description
This study is a randomized controlled trial of cancer survivors with clinically significant symptoms of insomnia to evaluate the efficacy of the cognitive-behavioral intervention Sleep Treatment Education Program-1 (STEP-1).
Participants in this study will be randomized to either the behavioral education session, Sleep Treatment Education Program-1 (STEP-1), which will instruct them on how to make changes to their sleep habits and behaviors or an enhanced usual care control program which will provides them with access to online relaxation programs and instruct them about how these programs can help improve sleep.
Participation in the study involves:
- Taking part in a 60-90 minute, one-on-one session using the Zoom video conference platform and completing a brief online questionnaires.
- Completing an approximately 10 minute follow-up questionnaire online with a brief phone call 4, and 8 weeks after the education session. An additional optional insomnia questionnaire will be requested at one month after the 8 week follow-up.
- Participants will receive a $25 gift card upon completing 4 \& 8 week questionnaires.
It expected that about 70 people will take part in this study.
- Conditions
- Cancer Survivors, Insomnia
- Being tested
- Sleep Treatment Education Program (STEP-1), Enhanced Usual Care
- Keywords
- Cancer Survivors, 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 Treatment Education Program (STEP-1)Behavioural
Video conference instruction on behavioral changes to improve sleep.
Enhanced Usual CareBehavioural
Video conference instruction on relaxation techniques to improve sleep.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Treatment Education Program (STEP-1) | Experimental | Prior to being randomized, all participants will complete health questionnaires.
Participants assigned to the Sleep Treatment Education Program (STEP-1) group will receive online instruction on making changes to sleep habits and health behaviors.
Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires. Receives: Behavioral: Sleep Treatment Education Program (STEP-1) |
| Enhanced Usual Care: Relaxation Education | Active comparator | Prior to being randomized, all participants will complete health questionnaires.
Participants assigned to the Enhanced Usual Care group will receive information on relaxation techniques to improve sleep
Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Change at 8 Weeks
The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
Measured: Baseline to 8 weeks
Secondary outcomes (5)
Profile of Mood States Change at 8 Weeks
The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.
Measured: Baseline to 8 weeks
Profile of Mood States Change at 4 Weeks
The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.
Measured: Baseline to 4 weeks
Change in Sleep Quality
The PROMIS Sleep Disturbance Short Form 8b (PROMIS-SD) is an 8 item scale used to assess sleep disturbances and their impact on overall sleep quality. Items include specific sleep problems (e.g., restless sleep) as well as satisfaction with sleep quality and amount of sleep. Item responses are summed to calculate a Total score, with raw scores (range 8-40) translated into t-scores (mean = 50, SD= 10). Higher PROMIS-SD Total t-scores indicate greater levels of sleep disturbance.
Measured: Baseline to 8 Weeks
Sleep Duration
Total sleep time in hours per night calculated from the Consensus Sleep Diary-Morning
Measured: Administered at 8 week follow-up
Insomnia Severity Change at 4 Weeks
The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
Measured: Baseline to 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start10 Mar 2023
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
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 (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Christopher Recklitis, PhD, Dana-Farber Cancer Institute
- Investigators
- Christopher Recklitis, PhD, MPH, Principal investigator, Dana-Farber Cancer Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519982
- Sponsor's protocol ID
- 20-516
- Other IDs
- 1R21CA267857
- Status last verified
- Jan 2026
- First submitted
- 26 Aug 2022
- Last updated
- 2 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Bice BL, Michaud AL, McCormick KG, Miklos EM, Descombes ID, Medeiros-Nancarrow C, Zhou ES, Recklitis CJ. Sleep Treatment Education Program for Cancer Survivors: Protocol for an Efficacy Trial. JMIR Res Protoc. 2024 Nov 28;13:e60762. doi: 10.2196/60762.
PubMed 39608001
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Treatment Education Program (STEP-1): An Online Educational Intervention for Insomnia in Cancer Survivors
- ClinicalTrials.gov ID
- NCT05519982
- Acronym / sponsor ID
- 20-516
- Conditions
- Cancer Survivors, Insomnia
- Keywords
- Cancer Survivors, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Posted 2 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to learn if single session online education programs can help improve cancer survivors' sleep.
Detailed description
This study is a randomized controlled trial of cancer survivors with clinically significant symptoms of insomnia to evaluate the efficacy of the cognitive-behavioral intervention Sleep Treatment Education Program-1 (STEP-1).
Participants in this study will be randomized to either the behavioral education session, Sleep Treatment Education Program-1 (STEP-1), which will instruct them on how to make changes to their sleep habits and behaviors or an enhanced usual care control program which will provides them with access to online relaxation programs and instruct them about how these programs can help improve sleep.
Participation in the study involves:
- Taking part in a 60-90 minute, one-on-one session using the Zoom video conference platform and completing a brief online questionnaires.
- Completing an approximately 10 minute follow-up questionnaire online with a brief phone call 4, and 8 weeks after the education session. An additional optional insomnia questionnaire will be requested at one month after the 8 week follow-up.
- Participants will receive a $25 gift card upon completing 4 \& 8 week questionnaires.
It expected that about 70 people will take part in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Treatment Education Program (STEP-1) | Experimental | Behavioral: Sleep Treatment Education Program (STEP-1)Prior to being randomized, all participants will complete health questionnaires. Participants assigned to the Sleep Treatment Education Program (STEP-1) group will receive online instruction on making changes to sleep habits and health behaviors. Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires. |
| Enhanced Usual Care: Relaxation Education | Active comparator | Behavioral: Enhanced Usual CarePrior to being randomized, all participants will complete health questionnaires. Participants assigned to the Enhanced Usual Care group will receive information on relaxation techniques to improve sleep Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires. |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 40-89
- History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior
- No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned
- Significant insomnia as evidenced by an Insomnia Severity Index score ≥12
- Regular access to the internet on a daily basis
Key exclusion criteria (11 listed)
- Survivors who report ever being diagnosed with Bipolar Disorder.
- Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months.
- Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia during the study period.
- Survivors diagnosed with sleep apnea who have declined treatment or are not adherent with treatment (as assessed by screening questions, see Appendix A).
- Survivors with suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A).
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 Treatment Education Program (STEP-1)Video conference instruction on behavioral changes to improve sleep. | Behavioural | Sleep Treatment Education Program (STEP-1) |
| Enhanced Usual CareVideo conference instruction on relaxation techniques to improve sleep. | Behavioural | Enhanced Usual Care: Relaxation Education |
Primary outcome
Insomnia Severity Change at 8 Weeks
Time frame: Baseline to 8 weeks
The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
5 secondary outcomes
Profile of Mood States Change at 8 Weeks
Time frame: Baseline to 8 weeks
Profile of Mood States Change at 4 Weeks
Time frame: Baseline to 4 weeks
Change in Sleep Quality
Time frame: Baseline to 8 Weeks
Sleep Duration
Time frame: Administered at 8 week follow-up
Insomnia Severity Change at 4 Weeks
Time frame: Baseline to 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39608001Bice BL, Michaud AL, McCormick KG, Miklos EM, Descombes ID, Medeiros-Nancarrow C, Zhou ES, Recklitis CJ. Sleep Treatment Education Program for Cancer Survivors: Protocol for an Efficacy Trial. JMIR Res Protoc. 2024 Nov 28;13:e60762. doi: 10.2196/60762.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Christopher Recklitis, PhD, MPH principal investigator
Dana-Farber Cancer Insitute
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 Treatment Education Program (STEP-1) in people with Cancer Survivors and 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 6 inclusion and 11 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 2 Feb 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. 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 2 Feb 2026). 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 Change at 8 Weeks (time frame: Baseline to 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 NCT05519982, 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 2 Feb 2026.