Cancer Survivors, Insomnia
Conditions
Keywords
Cancer Survivors, Insomnia
Brief summary
The purpose of the study is to learn if single session online education programs can help improve cancer survivors' sleep.
Detailed description
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.
Interventions
BEHAVIORALSleep Treatment Education Program (STEP-1)
Video conference instruction on behavioral changes to improve sleep.
BEHAVIORALEnhanced Usual Care
Video conference instruction on relaxation techniques to improve sleep.
Sponsors
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Age 40-89 * 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 * Regular access to the internet on a daily basis * 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 diagnosed with sleep apnea who have declined treatment or are not adherent with treatment (as assessed by screening questions, see Appendix A). * Survivors with suspected sleep apnea who have not completed an evaluation by a sleep specialist (as assessed by screening questions, see Appendix A). * 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 | 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 | 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 | 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. |
| Change in Sleep Quality | Baseline to 8 Weeks | 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. |
| Sleep Duration | Administered at 8 week follow-up | Total sleep time in hours per night calculated from the Consensus Sleep Diary-Morning |
| Insomnia Severity Change at 4 Weeks | Baseline to 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristopher Recklitis, PhD, MPH
Dana-Farber Cancer Insitute
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.8 Years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Insomnia Severity Index | 15.5 Units on a scale STANDARD_DEVIATION 3.8 |
| Profile of Mood States - Short Form (Total Mood Disturbance) | 11.7 Units on a scale STANDARD_DEVIATION 17.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 62 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 33 |
| other Total, other adverse events | 0 / 34 | 0 / 33 |
| serious Total, serious adverse events | 0 / 34 | 0 / 33 |
Outcome results
None listed