Cancer, Insomnia, Insomnia Due to Medical Condition
Conditions
Keywords
Insomnia, Insomnia Due to Medical Condition, Cancer
Brief summary
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).
Detailed description
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
Interventions
BEHAVIORALSTEP-YA with Coaching
Online instruction on behavioral changes to improve sleep with 2 additional individually coached session
BEHAVIORALSTEP-YA without Coaching
Online instruction on behavioral changes to improve sleep without additional individually coached session
Sponsors
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
To be determined by patient self-report from eligibility screening with potential participants. (See Appendix A for eligibility screening materials). Participants must be screened for eligibility ≤2 weeks prior to study enrollment. Participants who are screened earlier must be rescreened within this period. * Age 20-39 * History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year 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 ≥12 * Able to read and write in English
Exclusion criteria
* Survivors who report ever being diagnosed with Bipolar Disorder. * Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months. * Intention to adjust (decrease or increase) use of any prescribed or over-the-counter medications taken to decrease insomnia during the study period. * Survivors who report being diagnosed with sleep apnea who are not receiving recommended medical treatment for their sleep apnea (as assessed by screening questions, see Appendix A). * Survivors who report suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A). * Survivors who report their usual bedtime does not fall between 5:00 pm and 5:00 am. * Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel across time zones, or employment in a position that could impact public safety (such as air traffic-controller, operating heavy machinery) * Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently. * Prior participation in a research study which provided an educational or behavioral intervention for insomnia * Prior participation in a behavioral treatment or patient education program for insomnia delivered at the Dana-Farber Cancer Institute, or at Boston Children's Hospital. * Participation in behavioral or educational interventions for insomnia in the 2 years prior to enrollment. This includes in-person as well as synchronous and asynchronous online insomnia programs, but not independent use of books, workbooks or other written self-help materials addressing insomnia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Change at 8 Weeks | Baseline to 8-weeks post-intervention session | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Profile of Mood States Change at 8 Weeks | Baseline to 8-weeks post-intervention session | 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. |
| Profile of Mood States Change at 4 Weeks | Baseline to 4-weeks post-intervention session | 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. |
| Insomnia Severity Change at 4 Weeks | Baseline to 4-weeks post-intervention session | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristopher J Recklitis, PhD, MPH
Dana-Farber Cancer Institute
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29.29 Years STANDARD_DEVIATION 5.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Insomnia Severity Index | 15.17 Units on a scale STANDARD_DEVIATION 3.58 |
| Profile of Mood States - Short Form (Total Mood Disturbance) | 34.14 Units on a scale STANDARD_DEVIATION 21.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Sex/Gender, Customized Female | 37 Participants |
| Sex/Gender, Customized Male | 6 Participants |
| Sex/Gender, Customized Not Specified | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 28 |
| other Total, other adverse events | 0 / 27 | 0 / 28 |
| serious Total, serious adverse events | 0 / 27 | 0 / 28 |
Outcome results
None listed