Sleep Treatment Education Program for Cancer Survivors: STEP-Together

Not Applicable

Not yet recruiting

• Conditions: Insomnia; Insomnia Chronic; Survivorship

• Registration Number: NCT06736548
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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.

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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Study Start: 2025-05
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
Change in Perceived Cognitive impairment Scale from Baseline to 8 weeks Post-Intervention	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).
Change in Impact of Cognitive Function on Quality of Life Scale from Baseline to 8 weeks Post-Intervention	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 Ca...

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States