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Enrolling by Invitation

NCT Number: NCT06736548

Sleep Treatment Education Program for Cancer Survivors: STEP-Together

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.

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Key information

Conditions

Insomnia Dyssomnias Insomnia Chronic Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Survivorship

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Sleep Treatment Education Program Together (STEP-Together)

Behavioral

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 challenges. During the course of the session, participants are asked to use these suggestions to develop an individual sleep action plan they will use to improve their sleep.

Other names: STEP-Together

Coaching Session

Behavioral

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 outcomes

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

    Time frame: 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 outcomes

  1. 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

    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.

  2. Change in Perceived Cognitive impairment Scale from Baseline to 8 weeks Post-Intervention

    Time frame: 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).

  3. 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

    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 Cancer Therapy-Cognitive Function (FACT-COG).

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2024
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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