Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Symptoms and General Pathology

Breast Neoplasms

Sleep Initiation and Maintenance Disorders

Fatigue

Dyssomnias

Parasomnias

Pain

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Sleep Disorders, Intrinsic

All Drugs and Chemicals

Central Nervous System Depressants

Muscle Relaxants, Central

Psychotropic Drugs

Aromatase Inhibitors

Cyclobenzaprine

Antidepressive Agents

Antidepressive Agents, Tricyclic

Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.

5 milligrams orally 2 hours before bedtime

Norah L Henry, MD, PhD

Many women with breast cancer who are treated with aromatase inhibitor medications develop difficulty sleeping and fatigue during treatment. Some examples of aromatase inhibitor medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara). Frequently, sleeping pills do not work very well to improve sleep. Cyclobenzaprine (Flexeril) is a medication that was originally developed to treat muscle spasms. It may also improve sleep in patients with chronic pain disorders, such as fibromyalgia. In this study we are testing to see if cyclobenzaprine at bedtime will help improve sleep in women treated with aromatase inhibitors.

Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients

UMCC 2013.051: Prospective Pilot Study Evaluating the Use of Cyclobenzaprine for Treatment of Sleep Disturbance, Fatigue, and Musculoskeletal Symptoms in Aromatase Inhibitor-treated Breast Cancer Patients

We will assess the number of patients who continue to take the original aromatase inhibitor medication at the 24 week timepoint, as assessed using patient self-report and medical records

Persistence with cyclobenzaprine therapy for 24 weeks will be assessed using a medication diary. Safety will be assessed using CTCAE criteria

Will measure sleep quality using the Pittsburgh Sleep Quality Index at baseline and after 8 weeks of therapy with cyclobenzaprine. A total score is calculated for the Pittsburgh Sleep Quality Index. The total score ranges from 0-21, with higher scores representing worse sleep quality. Any reduction in PSQI total score was considered an improvement.

Will measure fatigue using the PROMIS fatigue questionnaire at baseline and after 8 weeks of therapy with cyclobenzaprine. The PROMIS Fatigue 7a score was calculated according to the information provided on the website. The raw score ranges from 7-35. The raw score is then converted to a T score according to the instruction on the website, with higher scores representing more fatigue. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. The change in fatigue is calculated by subtracting the T score at baseline from the T score at 8 weeks. Positive values represent worsening of fatigue.

Will measure average pain using the Brief Pain Inventory at baseline and after 8 weeks of therapy with cyclobenzaprine. On the Brief Pain Inventory, average pain is reported using a 0-10 scale, with higher numbers reflecting more pain. Change is calculated by subtracting pain at baseline is from pain at 8 weeks. A positive value represents an increase in pain.

Damon Runyon Cancer Research Foundation

Lynn Henry

Assistant Professor of Internal Med

Age, Continuous

Sex: Female, Male

The study was closed early for futility. The primary endpoint was not analyzed.

Dr. Norah Lynn Henry, Associate Professor of Internal Medicine

Only one of the two enrolled participants completed questionnaires after the baseline assessment

Number of Patients That Experience an Improvement in Sleep Quality as Assessed Using the Pittsburgh Sleep Quality Index (PSQI) With 8 Weeks of Cyclobenzaprine Therapy.

Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy

Change in Average Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy

Percentage of Subjects Who Continue to Take Aromatase Inhibitor Therapy

Percentage of Patients That Experience Adverse Events

Overall Study

Breast Diseases

Skin Diseases

Patients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture.

Ear acupuncture

Patients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour.

Psychoeducation

Gustav Dobos, Prof. MD

The aim of this clinical study is to investigate the extent to which ear acupuncture has an effect on insomnia in women with breast cancer. It will be investigated whether changes in sleep quality, fatigue, quality of life, stress, and psychological well-being can be achieved. In addition, a proinflammatory cytokine will be meassured.

Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer

Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer: a Randomized Controlled Trial

Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 self-assessment questions and 5 questions rated by the bed-partner or roommate. The 5 questions rated by the bed-partner or roommate are only used as clinical information and not included in qualitative analysis. The question whether a bed-partner or roommate is present is not included in qualitative analysis as well. The 18 self-assessment items are used to evaluate the sleep quality on 7 domains over the last month (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disturbances, use of sleep medication, and daytime dysfunction). Scoring of the answers is based on a scale from 0 to 3, whereby 3 reflects the negative extreme on a Likert Scale. The total score is generated by the summation of the component scores and can vary from 0 to 21, with a higher score corresponding to a reduced sleep quality. A cut-off score of 5 indicates a "poor" sleeper.

Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B)

Functional Assessment Of Chronic Illness Therapy - Fatigue (FACIT-F)

Hospital Anxiety and Depression Scale (HADS). It measures the 2 dimensions anxiety and depression. Scores range from 0 to 21 with higher values indicate higher distress. Values of \>8 indicate potential subclinical anxiety or depressive disorders.

Perceived Stress Scale (PSS). Perceived stress will be assessed by the 10-item version of the PSS, rated for the past month on a 5-point rating scale. For the summed items (range from 0 to 40) a higher total score indicates greater stress.

Number of patients with adverse events and type of the adverse event

Visual Analogue Scale (VAS). The Visual Analogue Scale is a continuous measurement device on which the degree of agreement is indicated by a cross between two end points. We define the end points of the Visual Analalogue Scale for expectations concerning treatment as "expecting the treatment to be not sucessfull at al" and "expecting the treatment to be extremely successful.

Karl and Veronica Carstens Foundation

Universität Duisburg-Essen

The eligible women would be randomized and stratified by sleep problems to two arms: (Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study (we anticipate about 20% attrition rate). The study interventions will begin after patients completed their treatment. The placebo control for acupuncture will be a validated sham acupuncture control Assessments will be made with daily diaries and with weekly questionnaires. There are ten sessions each lasting approximately 20 minutes. All participants will have PSG data collected.

acupuncture

placebo

David Spiegel

The proposed study will recruit 60 women with breast cancer who finished undergoing treatment who complain of persistent insomnia problems that began with onset of their cancer diagnosis. The eligible women would be randomized and stratified by sleep problems to two arms: (Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study (we anticipate about 20% attrition rate). The study interventions will begin after patients completed their treatment. The placebo control for acupuncture will be a validated sham acupuncture control Assessments will be made with daily diaries and with weekly questionnaires. PSG data will be collected on the subsample of the population. Data will be gathered via pencil-and-paper measures before, during, immediately following, one month following the completion of treatment and six months after the conclusion of treatment. In addition, actigraphy data (objective sleep continuity data) will be acquired prior to and following treatment

Acupuncture for Sleep Disruption in Cancer Survivors

Quality of life in breast cancer survivors after acupuncture will be measured through questionnaire using 28 item scale of functional assessment of chronic illness therapy- fatigue subscale (FACIT-F) version 4. Total score ranges from 0 to 108. A higher score indicates better quality of life.

National Institutes of Health (NIH)

National Center for Complementary and Integrative Health (NCCIH)

Stanford University

Jack, Samuel and Lulu Willson Professor in Medicine

Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program

SHUTi (Sleep Healthy Using the Internet)

Kelly Shaffer, PhD

This study will identify whether - and if so, how - tailoring would increase adoption of and benefit from an interactive internet intervention for insomnia called SHUTi (Sleep Healthy Using the Internet) for cancer caregivers. Participating caregivers' sleep and sleep-related characteristics will be characterized from a baseline assessment; then, caregivers will receive complementary and voluntary access to SHUTi. Among caregivers who choose to use SHUTi, intervention use, perceived appropriateness, and effects on sleep and quality of life will be assessed. Among caregivers who choose not to use SHUTi, reasons and barriers to using the intervention will be assessed.

Insomnia is a significant public health problem with substantial medical, psychological and financial ramifications. About 50-75% of the 3.5 million Americans who provide unpaid medical, practical, and/or emotional support for a loved one with cancer endorse clinically significant sleep disturbance. Understanding caregivers' psychosocial risk factors and needs, and the extent to which these are unique to the cancer caregiving context, will ensure appropriate and effective interventions for cancer caregivers with insomnia.

Existing psychosocial services for caregivers are primarily delivered in-person. Although such interventions are effective, they suffer from low enrollment, high dropout, and limited reach to caregivers who already have inadequate healthcare access, like caregivers from lower SES or those in rural areas. Digital health interventions can lower barriers to entry to supportive care for caregivers as they are conveniently accessible anywhere and anytime from an Internet-enabled device. Sleep Healthy Using the Internet (SHUTi) is a NCI-designated research-tested intervention that delivers cognitive-behavioral therapy for insomnia (CBT-I) and holds significant potential to accessibly treat insomnia for cancer caregivers. Most digital health interventions tested among caregivers, however, have been developed de novo for specific caregiving contexts. The implicit assumption underlying highly tailored interventions for caregivers is that caregivers have different deficits, risk factors, and needs from non-caregivers. This assumption has not often been tested, and therefore the extent to which caregivers want and need tailoring for digital health interventions is not known. This study is therefore designed to provide the data necessary to ensure the highest quality, impact, and efficiency from existing evidence-based digital health interventions to meet pressing psychosocial needs among cancer caregivers. Specifically, this study will directly inform next research steps for tailoring and testing SHUTi for optimal impact and reach among caregivers.

The SHUTi Program: SHUTi is a self-guided (i.e., automated), interactive, and tailored web-based program modeled on the primary tenants of face-to-face CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, relapse prevention). Intervention content is metered out over time through 6 "Cores." Users obtain access to a new Core based on a time and event-based schedule (e.g., 7 days after completion of previous Core). This schedule is consistent with the recommendation from a task force commissioned by the Academy of Sleep Medicine, which deemed that an average of 6 - 8 sessions constitutes "adequate treatment exposure". The SHUTi program relies on user-entered online Sleep Diaries to track progress and to tailor treatment recommendations (i.e., assign a "sleep restriction" window). Each Core acts as an online analog for the weekly sessions typically used when delivering CBT-I in a face-to-face format, following the same general structure: 1) Core objectives (what will be learned and why this information is important), 2) review of previous week's homework and sleep diary data, 3) new intervention material, 4) assignment of homework (treatment strategies for the coming week), and 5) a summary of the Core's main points. Intervention content is enhanced through a variety of interactive features, including personalized goal-setting, graphical feedback based on inputted symptoms, animations / illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Automated emails are also sent to encourage program adherence. There is no content that is specifically about cancer or caregiving.

Caregivers participating in this study will complete a baseline assessment (questionnaires and 2 weeks of daily sleep diaries), and then will receive complementary and voluntary access to SHUTi. Participants who choose to complete 1 or more SHUTi Cores will complete a follow-up assessment of questionnaires and 2 weeks of sleep diaries; participants who choose not to complete any SHUTi cores will be asked to provide brief feedback regarding their reasons/barriers.

The Better Sleep for Supporters With Insomnia Study

Optimizing Efficiency and Impact of Internet-delivered Insomnia Treatment for Cancer Caregivers

Number of SHUTi Cores completed by participants

Insomnia severity index; 7 items; summed scores range from 0 to 28 (higher scores indicate more severe insomnia symptoms)

Data collected from sleep diary: Time fell asleep - Time attempting to fall asleep

Data collected from sleep diary: Total time awake between time feel asleep and final morning waking

Data collected from sleep diary: Nightly rating of perceived sleep quality from very poor to very good

Dysfunctional Beliefs and Attitudes about Sleep; 16 items; averaged scores range from 0 to 10 (higher scores indicate more dysfunctional attitudes and beliefs about sleep)

Sleep Self-Efficacy Scale; 13-items; averaged scores range from 0 to 10 (higher scores indicate greater self-efficacy)

Sleep Locus of Control Scale; 4-item subscales for internal and chance locus of control, respectively; averaged scores per scale range from 1 to 6 (higher scores indicate higher belief in the locus of control measured)

Pearlin Stress Scale - Overload subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived burden)

Pearlin Stress Scale - Caregiving Competence subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived competence)

PROMIS SF v2.0 - Physical Function 8b; 8 items; scored on a normalized T-score distribution (higher scores indicate higher physical function)

PROMIS SF v2.0 - Anxiety 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher anxiety)

PROMIS SF v2.0 - Depression 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher depression)

PROMIS SF v2.0 - Fatigue 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher fatigue)

PROMIS SF v2.0 - Sleep Disturbance 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher sleep disturbance)

PROMIS SF v2.0 - Ability to Participant in Social Roles and Activities 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher social function)

PROMIS SF v2.0 - Pain Interference 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher pain interference)

PROMIS SF v2.0 - Pain Intensity item; 1 item (higher score indicate higher pain intensity)

Internet Intervention Utility Questionnaire (UQ) for SHUTi; 18 items; items examined individually

Internet Intervention Impact and Effectiveness Questionnaire (IEQ) for SHUTi; 29 items; items examined individually

Internet Intervention Adherence Questionnaire (AQ) for SHUTi; 20 items; items examined individually

Open-ended survey items regarding barriers to using SHUTi

Open-ended survey items regarding appropriateness of SHUTi to address caregivers' sleep needs

University of Virginia

Assistant Professor

Eszopiclone

Hypnotics and Sedatives

Placebo

Joel E Dimsdale, MD

To assess the effectiveness of Lunesta on cancer patients who have received chemotherapy and who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will:

* improve sleep thereby decreasing need for opiates via PCA
* improve sleep thereby decreasing pain by self report
* improve sleep thereby decreasing fatigue by self report

Pain and fatigue are the most common symptom complaints of cancer patients. Although dramatic improvements have come about in recognizing and treating cancer related pain, less progress has been made in treating fatigue. Interventions to improve sleep may offer benefit in terms of pain and fatigue.

One of the less commonly recognized side effects of opiate use is sleep disruption.

Experimentally-induced sleep disruption lowers the threshold for detection of painful stimuli. Thus, although opiates are obviously helpful for pain, they do so at certain "costs": they increase next day fatigue, constipation, and have other side effects; they disrupt sleep which further increases next day fatigue; and finally, by virtue of their sleep disruptive properties, they lower the threshold for pain stimuli.

Cancer patients requiring chemotherapy commonly require PCA because of oral mucositis. The objective of this study is to assess whether opiate usage may be reduced and complaints of fatigue and pain be lessened if patients had better sleep.

Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer

Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer

Pain was assessed with a 10-cm visual analog scale (0 = "no pain at all"; 10 = "severe, uncontrolled pain").

Patients completed the five-item Profile of Mood States Scale, Short Form (POMS-SF) Fatigue-Inertia Scale to rate their fatigue complaints (scores range from 0 to 28; higher scores denote more fatigue).

Morphine or dilaudid dose delivered at fixed rate with optional self-administered prn boluses. Dilaudid doses were converted into morphine equivalents by multiplying the dose by 5.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients	NCT01921296	Sleep Initiatio... Pain	Cyclobenzaprine	18 Years -	University of Michigan Rogel Cancer Center
Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer	NCT03874598	Breast Neoplasm	Ear acupuncture Psychoeducation	18 Years - 75 Years	Universität Duisburg-Essen
Acupuncture for Sleep Disruption in Cancer Survivors	NCT01162018	Sleep Initiatio... Breast Cancer	acupuncture placebo	18 Years -	Stanford University
The Better Sleep for Supporters With Insomnia Study	NCT04661306	Family Caregive... Cancer Insomnia Sleep Initiatio...	SHUTi (Sleep He...	18 Years -	University of Virginia
Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer	NCT03874598	Breast Neoplasm	Ear acupuncture Psychoeducation	18 Years - 75 Years	Universität Duisburg-Essen
Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients	NCT01921296	Sleep Initiatio... Pain	Cyclobenzaprine	18 Years -	University of Michigan Rogel Cancer Center
The Better Sleep for Supporters With Insomnia Study	NCT04661306	Family Caregive... Cancer Insomnia Sleep Initiatio...	SHUTi (Sleep He...	18 Years -	University of Virginia
Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer	NCT00365261	Sleep Initiatio...	Eszopiclone Placebo	20 Years - 75 Years	University of California, San Diego

Spots Global Cancer Trial Database for sleep initiation and maintenance disorders