Sleep Treatment Education Program for Cancer Survivors: STEP-Together
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorDana-Farber Cancer Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
The Sleep Treatment Education Program Together (STEP-Together)
BehavioralSTEP-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.
Coaching Session
BehavioralCoaching 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: STEP-Together InterventionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Insomnia Severity Index (ISI) Score from 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.
Time frame
Baseline to 8 weeks post-interventionSecondary 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
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.
Time frame
Baseline to 8 weeks post-intervention2
Change in Perceived Cognitive impairment Scale from 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).
Time frame
Baseline to 8 weeks post-intervention3
Change in Impact of Cognitive Function on Quality of Life Scale from 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).
Time frame
Baseline to 8 weeks post-interventionSponsors and contacts
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Source ClinicalTrials.gov