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STEP-Together for Insomnia in Cancer Survivors

This study is testing a program called STEP-Together (Sleep Treatment Education Program Together) for cancer survivors who are experiencing insomnia (difficulty sleeping). The program involves a single group session delivered online, followed by brief coaching sessions to help you manage your sleep. We are looking for about 100 cancer survivors, aged 18-89, who have been off active cancer treatment for at least four months and have significant insomnia. The main goal is to see if your insomnia symptoms improve after 8 weeks. You'll need internet access and be able to read and write in English to participate.

Study design
This is a single-arm study, meaning all participants will receive the STEP-Together intervention. Approximately 90 people are expected to participate.
What's involved
Participation involves screening for eligibility, completing questionnaires, attending a virtual group session, and brief coaching sessions. Your participation is expected to last about 16 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your insomnia symptoms will be measured at 8 weeks after the intervention.

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NCT06736548

Sleep Treatment Education Program for Cancer Survivors: STEP-Together

Enrolling by Invitation
NAAges 18–89InterventionalTreatment
Dana-Farber Cancer Institute
~100 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:The Sleep Treatment Education Program Together (STEP-Together)Coaching Session

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention
Measured over Baseline to 8 weeks post-intervention

Conditions

Insomnia
Insomnia Chronic
Survivorship

Explore related trials

Cancer SurvivorshipInsomnia

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Christopher Recklitis, PhD, MPH · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-InterventionBaseline 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.