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Enrolling by invitation NCT06736548

Sleep Treatment Education Program for Cancer Survivors: STEP-Together

No phase Interventional Insomnia Insomnia Chronic Survivorship

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Sleep Treatment Education Program Together (STEP-Together), Coaching Session.
Who it may be relevant to
Registry conditions: Insomnia, Insomnia Chronic, Survivorship. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sleep Treatment Education Program Together (STEP-Together): An Online Group Educational Intervention for Insomnia in Cancer Survivors

Overview

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.

Interventions

  • Behavioral The Sleep Treatment Education Program Together (STEP-Together)
    STEP-Together is delivered in a single videoconference group session delivered live by a presenter. During the session, the participants are able to see and hear the presenter, view the presentation slides, and ask questions. The presentation includes educational information on the problem of insomnia after cancer and specific suggestions for improving sleep. Suggestions are presented in four sections addressing lifestyle issues, sleep environment, sleep timing, and managing expectations and cha
  • Behavioral Coaching Session
    Coaching sessions are brief (\<1hour) sessions intended to support participants in implementing their personal sleep self-management plan. In the session, participants are asked to review their progress with their plan, report on areas of sucess and difficulty with adoption, and to problem solve with the study team as needed to support their sucessful implementation their plan.

Primary outcome measures

  • Change in Insomnia Severity Index (ISI) Score from Baseline to 8 weeks Post-Intervention [Time frame: Baseline to 8 weeks post-intervention]
Secondary outcome measures (3)
  • 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 [Time frame: Baseline to 8 weeks post-intervention]
  • Change in Perceived Cognitive impairment Scale from Baseline to 8 weeks Post-Intervention [Time frame: Baseline to 8 weeks post-intervention]
  • Change in Impact of Cognitive Function on Quality of Life Scale from Baseline to 8 weeks Post-Intervention [Time frame: Baseline to 8 weeks post-intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Dana Farber Cancer Institute — Boston

Identifiers

NCT: NCT06736548 · 24-505

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗