Clinical trial · Interventional
Sleep Treatment Education Program for Cancer Survivors: STEP-Together
Sleep Treatment Education Program Together (STEP-Together): An Online Group Educational Intervention for Insomnia in Cancer Survivors
NCT06736548CI-TRIAL-00120418enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insomnia | — | UNRESOLVED | — |
| Insomnia Chronic | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Coaching Session | Behavioral | — | UNRESOLVED |
| The Sleep Treatment Education Program Together (STEP-Together) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- STEP-Together Intervention
- description
- 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.
- interventionNames
- Behavioral: The Sleep Treatment Education Program Together (STEP-Together)
- Behavioral: Coaching Session
Primary outcomes (1)
- measure
- Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention
- timeFrame
- Baseline to 8 weeks post-intervention
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.