Clinical trial NCT06736548: Sleep Treatment Education Program for Cancer Survivors: STEP-Together
Official title: Sleep Treatment Education Program Together (STEP-Together): An Online Group Educational Intervention for Insomnia in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Insomnia Chronic
Survivorship
Keywords: Insomnia
Chronic Insomnia
Cancer Survivorship
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group
Primary purpose: TREATMENT

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.

Participation in this research study is expected to last about 16 weeks.

It is expected about 90 people will participate in this research study.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention
timeFrame: Baseline to 8 weeks post-intervention
Secondary outcomes:
measure: 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
timeFrame: Baseline to 8 weeks post-intervention
measure: Change in Perceived Cognitive impairment Scale from Baseline to 8 weeks Post-Intervention
timeFrame: Baseline to 8 weeks post-intervention
measure: Change in Impact of Cognitive Function on Quality of Life Scale from Baseline to 8 weeks Post-Intervention
timeFrame: Baseline to 8 weeks post-intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christopher Recklitis, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: