Sleep Treatment Education Program for Cancer Survivors: STEP-Together

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Survivorship; Insomnia; Insomnia Chronic

Treatments: Behavioral: The Sleep Treatment Education Program Together (STEP-Together); Behavioral: Coaching Session

Study type: Interventional

Funder types: Other

Identifiers

NCT06736548

24-505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

STEP-Together Intervention

Experimental group

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.

Treatment:

Behavioral: Coaching Session

Behavioral: The Sleep Treatment Education Program Together (STEP-Together)