The purpose of the study is to learn if a single online education session, with or without individualized coaching sessions, can help improve young adult cancer survivors' (YACS) sleep. The name of the study intervention is Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA).
This study is a randomized controlled trial of young adult cancer survivors with clinically significant symptoms of insomnia to evaluate the cognitive-behavioral based Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA). All participants will take part in a single STEP-YA session, during which they will complete baseline measures prior to randomization and then receive the STEP-YA intervention. Participants will then be randomly assigned to receive the STEP-YA intervention either, 1) alone (non-coaching condition), or 2) with the addition of 2 remote coaching sessions (coaching condition). Participants will also complete follow-up measures 4 and 8 weeks post-baseline. It expected that about 74 people will take part in this study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Online instruction on behavioral changes to improve sleep with 2 additional individually coached session
Online instruction on behavioral changes to improve sleep without additional individually coached session
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 post-intervention session
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 post-intervention session
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 post-intervention session
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.
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Time frame: Baseline to 4-weeks post-intervention session