The purpose of the study is to learn if single session online education programs can help improve cancer survivors' sleep.
This study is a randomized controlled trial of cancer survivors with clinically significant symptoms of insomnia to evaluate the efficacy of the cognitive-behavioral intervention Sleep Treatment Education Program-1 (STEP-1). Participants in this study will be randomized to either the behavioral education session, Sleep Treatment Education Program-1 (STEP-1), which will instruct them on how to make changes to their sleep habits and behaviors or an enhanced usual care control program which will provides them with access to online relaxation programs and instruct them about how these programs can help improve sleep. Participation in the study involves: * Taking part in a 60-90 minute, one-on-one session using the Zoom video conference platform and completing a brief online questionnaires. * Completing an approximately 10 minute follow-up questionnaire online with a brief phone call 4, and 8 weeks after the education session. An additional optional insomnia questionnaire will be requested at one month after the 8 week follow-up. * Participants will receive a $25 gift card upon completing 4 \& 8 week questionnaires. It expected that about 70 people will take part in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
70
Video conference instruction on behavioral changes to improve sleep.
Video conference instruction on relaxation techniques to improve sleep.
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Insomnia Severity Change at 8 Weeks
The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
Time frame: Baseline to 8 weeks
Profile of Mood States Change at 8 Weeks
The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.
Time frame: Baseline to 8 weeks
Profile of Mood States Change at 4 Weeks
The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.
Time frame: Baseline to 4 weeks
Change in Sleep Quality
The PROMIS Sleep Disturbance Short Form 8b (PROMIS-SD) is an 8 item scale used to assess sleep disturbances and their impact on overall sleep quality. Items include specific sleep problems (e.g., restless sleep) as well as satisfaction with sleep quality and amount of sleep. Item responses are summed to calculate a Total score, with raw scores (range 8-40) translated into t-scores (mean = 50, SD= 10). Higher PROMIS-SD Total t-scores indicate greater levels of sleep disturbance.
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Time frame: Baseline to 8 Weeks
Sleep Duration
Total sleep time in hours per night calculated from the Consensus Sleep Diary-Morning
Time frame: Administered at 8 week follow-up
Insomnia Severity Change at 4 Weeks
The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
Time frame: Baseline to 4 Weeks