InsomniaNCT06736548
Sleep Treatment Education Program for Cancer Survivors: STEP-Together
A study testing The Sleep Treatment Education Program Together (STEP-Together) and Coaching Session in people with Insomnia and Insomnia Chronic, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a synchronous group session by videoconference. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Insomnia Chronic, Survivorship
- What is being tested?
- The Sleep Treatment Education Program Together (STEP-Together) and Coaching Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2025to 31 Oct 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-89
- History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 6 months 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 ≥ 8
- Regular access to the internet
- Able to read and write in English
Who cannot join
- Usual bedtime does not fall between 5:00 pm and 5:00 am.
- Employment in a position where falling asleep at work could impact public safety (such as air traffic-controller, operating heavy machinery).
- Ever diagnosed with Bipolar Disorder or with Seizure Disorder, currently taking medications to prevent a seizure, or have experienced a seizure in the prior 12 months.
- Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.
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
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Sleep Treatment Education Program Together (STEP-Together): An Online Group Educational Intervention for Insomnia in Cancer Survivors
This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a synchronous group session by videoconference.
Read the detailed description
This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a virtual group session.
The research study procedures including screening for eligibility and questionnaires.
Participation in this research study is expected to last about 16 weeks.
It is expected about 90 people will participate in this research study.
- Conditions
- Insomnia, Insomnia Chronic, Survivorship
- Being tested
- The Sleep Treatment Education Program Together (STEP-Together), Coaching Session
- Keywords
- Insomnia, Chronic Insomnia, Cancer Survivorship
- 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.
The Sleep Treatment Education Program Together (STEP-Together)Behavioural
Also called STEP-Together
STEP-Together is delivered in a single videoconference group session delivered live by a presenter. During the session, the participants are able to see and hear the presenter, view the presentation slides, and ask questions. The presentation includes educational information on the problem of insomnia after cancer and specific suggestions for improving sleep. Suggestions are presented in four sections addressing lifestyle issues, sleep environment, sleep timing, and managing expectations and challenges. During the course of the session, participants are asked to use these suggestions to develop an individual sleep action plan they will use to improve their sleep.
Coaching SessionBehavioural
Coaching sessions are brief (<1hour) sessions intended to support participants in implementing their personal sleep self-management plan. In the session, participants are asked to review their progress with their plan, report on areas of sucess and difficulty with adoption, and to problem solve with the study team as needed to support their sucessful implementation their plan.
| Study group | Role | What they receive |
|---|---|---|
| STEP-Together Intervention | Experimental | Enrolled participants will complete the educational intervention session (STEP-Together) delivered by an interventionist during an online group videoconference session.
-Up to 12 participants will also take part in a coaching session 1 week after the virtual intervention session. Receives: Behavioral: The Sleep Treatment Education Program Together (STEP-Together); Behavioral: Coaching Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention
Assessed by the Insomnia Severity Index, a 7-item measure measuring insomnia over the previous two weeks with answers graded on a 5-point Likert scale, ranging from 0 "No Problem" to "4 "Very Severe" for a total score range of 0 to 28. A higher score reflects moderate to severe insomnia symptoms.
Measured: Baseline to 8 weeks post-intervention
Secondary outcomes (3)
Change in Total Mood Disturbance (TMD) Scale from the Profile of Mood States - Short Form (POMS-SF) Score from Baseline to 8 weeks Post-Intervention
Assessed by the POM-SF, a 35-item measure of feelings and mood over the 2 weeks prior to questionnaire administration. Answers are graded on a 5-point Likert scale, ranging from 0 "Not At All" to 4 "Extremely." A higher score reflects more negative moods and lower vigor.
Measured: Baseline to 8 weeks post-intervention
Change in Perceived Cognitive impairment Scale from Baseline to 8 weeks Post-Intervention
Assessed by the Perceived Cognitive Impairment Scale, a 20-item measure with answers graded on a 5-point Likert scale, ranging from 0 "Never" to 4 "Several Times a Day" for a total score range of 0 to 80. A higher score indicates poorer functioning. This scale is found in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG).
Measured: Baseline to 8 weeks post-intervention
Change in Impact of Cognitive Function on Quality of Life Scale from Baseline to 8 weeks Post-Intervention
Assessed by the Impact of Cognitive Function on Quality of Life Scale, a 4-item measure with answers graded on a 5-point Likert scale, ranging from 0 "Not At All" to 4 "Very Much" for a total score range of 0 to 16. A higher score indicates better cognitive function and a lower impact on quality of life. This scale is found in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG).
Measured: Baseline to 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start25 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Recklitis, PhD, Dana-Farber Cancer Institute
- Investigators
- Christopher Recklitis, PhD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736548
- Sponsor's protocol ID
- 24-505
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Treatment Education Program Together (STEP-Together): An Online Group Educational Intervention for Insomnia in Cancer Survivors
- ClinicalTrials.gov ID
- NCT06736548
- Acronym / sponsor ID
- 24-505
- Conditions
- Insomnia, Insomnia Chronic, Survivorship
- Keywords
- Insomnia, Chronic Insomnia, Cancer Survivorship
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 16 Dec 2024 (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 single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a synchronous group session by videoconference.
Detailed description
This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a virtual group session.
The research study procedures including screening for eligibility and questionnaires.
Participation in this research study is expected to last about 16 weeks.
It is expected about 90 people will participate in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group
| Arm | Type | Receives |
|---|---|---|
| STEP-Together Intervention | Experimental | Behavioral: The Sleep Treatment Education Program Together (STEP-Together), Behavioral: Coaching SessionEnrolled participants will complete the educational intervention session (STEP-Together) delivered by an interventionist during an online group videoconference session. -Up to 12 participants will also take part in a coaching session 1 week after the virtual intervention session. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-89
- History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 6 months 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 ≥ 8
- Regular access to the internet
Key exclusion criteria (4 listed)
- Usual bedtime does not fall between 5:00 pm and 5:00 am.
- Employment in a position where falling asleep at work could impact public safety (such as air traffic-controller, operating heavy machinery).
- Ever diagnosed with Bipolar Disorder or with Seizure Disorder, currently taking medications to prevent a seizure, or have experienced a seizure in the prior 12 months.
- Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.
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 |
|---|---|---|
| The Sleep Treatment Education Program Together (STEP-Together)Also: STEP-TogetherSTEP-Together is delivered in a single videoconference group session delivered live by a presenter. During the session, the participants are able to see and hear the presenter, view the presentation slides, and ask questions. The presentation includes educational information on the problem of insomnia after cancer and specific suggestions for improving sleep. Suggestions are presented in four sections addressing lifestyle issues, sleep environment, sleep timing, and managing expectations and challenges. During the course of the session, participants are asked to use these suggestions to develop an individual sleep action plan they will use to improve their sleep. | Behavioural | STEP-Together Intervention |
| Coaching SessionCoaching sessions are brief (<1hour) sessions intended to support participants in implementing their personal sleep self-management plan. In the session, participants are asked to review their progress with their plan, report on areas of sucess and difficulty with adoption, and to problem solve with the study team as needed to support their sucessful implementation their plan. | Behavioural | STEP-Together Intervention |
Primary outcome
Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention
Time frame: Baseline to 8 weeks post-intervention
Assessed by the Insomnia Severity Index, a 7-item measure measuring insomnia over the previous two weeks with answers graded on a 5-point Likert scale, ranging from 0 "No Problem" to "4 "Very Severe" for a total score range of 0 to 28. A higher score reflects moderate to severe insomnia symptoms.
3 secondary outcomes
Change in Total Mood Disturbance (TMD) Scale from the Profile of Mood States - Short Form (POMS-SF) Score from Baseline to 8 weeks Post-Intervention
Time frame: Baseline to 8 weeks post-intervention
Change in Perceived Cognitive impairment Scale from Baseline to 8 weeks Post-Intervention
Time frame: Baseline to 8 weeks post-intervention
Change in Impact of Cognitive Function on Quality of Life Scale from Baseline to 8 weeks Post-Intervention
Time frame: Baseline to 8 weeks post-intervention
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 4 Aug 2026.
- 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.
Christopher Recklitis, PhD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Sleep Treatment Education Program Together (STEP-Together) and Coaching Session in people with Insomnia and Insomnia Chronic, 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 4 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: enrolling by invitation, as of the sponsor's last update on 4 Aug 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?
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?
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?
Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention (time frame: Baseline to 8 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2026.