Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Behaviors and Mental Disorders

Rare Diseases

Fatigue

Glioma

Parasomnias

Brain Neoplasms

Astrocytoma

Oligodendroglioma

Dyssomnias

Ependymoma

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Oligoastrocytoma

Anaplastic Oligoastrocytoma

Anaplastic Ependymoma

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Melatonin

A total of 8 questionnaires regarding fatigue taking approximately 30 minutes each, given before radiation therapy, weekly during, and after completion.

Questionnaire

Mark R. Gilbert

This goal of this research study is to learn more about fatigue, sleep quality, and other symptoms in patients with primary brain tumors who are being treated with radiation therapy.

Objectives:

PRIMARY OBJECTIVE:

1. The primary objective of this study is to provide preliminary data describing the severity and change over time in fatigue using the Brief Fatigue Inventory (BFI) during radiation therapy for patients with primary gliomas.

SECONDARY OBJECTIVES:

1. To evaluate longitudinal changes in the severity of symptoms and the mean symptom burden as measured by the M.D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) and mood using the Profile of Mood States (POMS) during radiation therapy.
2. To assess alterations in circadian rhythms using actigraphy during radiation therapy and the association with sleep quality tools - Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale(ESS), and the severity of BFI and MDASI-BT scores over time.
3. To explore the association between the levels of salivary hormones (melatonin and cortisol) and the occurrence of fatigue and symptom burden.

Questionnaires:

If you decide to take part in this study, before starting radiation therapy, weekly during radiation therapy, and again 3-4 weeks and 6-8 weeks after completing radiation therapy, you will complete 4 questionnaires. Three (3) of the questionnaires will be completed during a study visit, and the last 1 will be completed at home the next time you come into the clinic. You will return the questionnaire completed at home to the study doctor at a study visit. The questionnaires will ask questions about fatigue, any symptoms you may have, and your sleeping habits. It should take about 30 minutes total to complete all of the questionnaires each time.

Sleep Diary:

You will complete a sleep diary. The sleep diary will be provided to you before starting radiation therapy. You will record information in it about your sleep habits, caffeinated beverages and drugs you may take, the quality of your sleep, and how you feel when you wake up. You will complete the sleep diary during the 48 hours that you are wearing the actigraphy watch. You will bring the sleep diary to the clinic every week for the study doctor to review.

Actigraphy Watch:

You will wear an actigraphy watch on your wrist for 48 hours before starting radiation therapy, for 48 hours each week during radiation therapy, and again for 48 hours 3-4 weeks and 6-8 weeks after completing radiation therapy. The actigraphy watch will measure your activity during the day and night. You will bring the actigraphy watch to the clinic every week for the study doctor to review.

Saliva Collection:

You will collect a saliva sample four times during the day before starting radiation therapy, one time during the third and last week of radiation therapy, and again 3-4 weeks and 6-8 weeks after completing radiation therapy. These samples will be used to measure levels of neurotransmitters and hormone levels. These are substances which are released in the body that may affect sleep and the immune system.

Length of Study:

You will remain on study for about 8 weeks after you complete radiation therapy.

This is an investigational study. Up to 20 patients will take part in this study. All will be enrolled at M.D. Anderson.

Fatigue, Sleep and Cytokines in Primary Brain Tumor (PBT) Patients

Relationship Among Fatigue, Symptoms, Melatonin and Sleep in PBT Patients Undergoing Radiation Therapy

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Pain

Breast Diseases

Skin Diseases

Aromatase Inhibitors

Postmenopausal women starting aromatase inhibitor therapy will undergo assessment with questionnaires and actigraphy before starting AI therapy and after 3 months of treatment.

Norah L Henry, MD, PhD

Aromatase inhibitors are commonly prescribed for treatment of postmenopausal women with breast cancer. These medications can cause side effects in some women, and occasionally they can be quite bothersome. We are doing a study to better understand the side effects of aromatase inhibitors so that we can hopefully treat them better or possibly prevent them. In particular, we are interested in pain and difficulty sleeping. This study is designed to assess the effect of aromatase inhibitors on pain, sleep quality, and fatigue and the interplay of these side effects and their subsequent impact on daily activity. Each participant will fill out a series of questionnaires about pain, sleep quality, and fatigue and will also complete a sleep diary and wear an actigraphy watch for 10 days before starting an aromatase inhibitor and after taking it for 3 months. We hope to learn more about these symptoms so we can better manage medication toxicity in the future.

Examining the Relationships Between Sleep, Fatigue, and Pain in Aromatase Inhibitor-treated Patients

Prospective Pilot Study Evaluating the Inter-relationships Between Sleep Disturbance, Fatigue, Pain, and Daytime Activity in Breast Cancer Patients Starting Aromatase Inhibitor Therapy

Feasibility will be measured by the proportion of breast cancer patients who are starting aromatase inhibitor therapy who complete baseline and 3 month assessment questionnaires and also enter actigraphy data correctly at least 85% of the time.

We will evaluate patterns of symptoms reported by subjects and the apparent impact of these symptoms on both daytime function and sleep quality.

We will analyze the change in sleep, pain, fatigue, and symptom severity index between baseline and 12 weeks. We will correlate changes in symptoms from baseline to 12 weeks with actigraphy activity.

Damon Runyon Cancer Research Foundation

University of Michigan

Assistant Professor of Internal Medicine, Medical School

Diseases and Abnormalities at or Before Birth

Sclerosis

Tuberous Sclerosis

Sleep Wake Disorders

Neurologic Manifestations

Mental Disorders

Psychotic Disorders

Hamartoma

Neoplasms, Multiple Primary

Syndrome

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Tuberous Sclerosis Complex

Questionnaires electroencephalogram (EEG) Actigraphy polysomnography

* Epworth sleepiness scale
* Pittsburgh sleep quality Index (PSQI)
* EQ-5D Adults
* Pediatric Daytime Sleepiness scale (PDSS)
* Sleep disturbance Scale for Children (SDSC
* EQ-5D Children
* Sleaping diary

Questionnaires

is an electrophysiological monitoring method to record electrical activity of the brain

electroencephalogram (EEG)

type of sleep study, is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine

polysomnography

type of sleep study based on bracelet around the wrist

Actigraphy

Veerle Van Mossevelde, Study coordinator

Dirk De Clippeleir, Study coordinator

Veerle Van Mossevelde, Datanurse

Anna Jansen, PhD, MD

Sonia De Weerdt, MD

Alessandra Pereira,, PhD, MD

Magda Nunes, PhD, MD

Oliviero Bruni, PhD, MD

Paolo Curatolo, PhD, MD

The proposed research project is aimed at further characterization of sleep problems and evaluation of their impact in children and adults with TSC, excluding epilepsy as contributing factor. Questionnaire-based studies have shown that sleep problems occur in up to half of the children and a third of adults with tuberous sclerosis complex (TSC). However, there is only limited information on the nature of sleep problems and their impact on patients with TSC and their families.

Questionnaire-based studies have shown that sleep problems occur in up to half of the children and a third of adults with tuberous sclerosis complex (TSC). However, there is only limited information on the nature of sleep problems and their impact on patients with TSC and their families. It is known from a questionnaire-based study in children with TSC that they often wake early or wake frequently during the night, and that they can be more tired during the day. In some children, sleep-problems seem to be related to the presence of seizures during the night. This has been confirmed in a study on 10 children with TSC and epilepsy by a combination of polysomnography (sleep study) and electroencephalography (EEG). A questionnaire-based study in adults also revealed the association with epilepsy features, and showed influence of mental health complaints on sleep.

Sleep structure and quality will be assessed through formal sleep studies (polysomnography and actigraphy). The influence of abnormal brain activity on sleep will be mapped by simultaneous recording of brain activity by means of EEG. The impact of sleep disorders will be determined through interviews with individuals with TSC and their relatives. The investigators will also use questionnaires and diaries to supplement their findings.

Importance: It is expected that the results of this study will 1) improve our understanding of sleep problems in TSC, 2) provide additional information on the influence of TSC on sleep, 3) give a more in-depth view on the impact of sleep problems on the lives of individuals with TSC and their families, 4) increase awareness about sleep problems in TSC, and 5) contribute to a better management of sleep problems by patients and families.

2 groups:

* 30 Children(0-18y) withTSC without epilepsy
* 30 Adults(\>18y) withTSC without epilepsy

Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)

- Sleep efficiency (SE%): the percentage ratio between total sleep time and time in bed (TST/TIB\*100)

Universitair Ziekenhuis Brussel

Study coordinator

Sleep Initiation and Maintenance Disorders

Sleep Disorders, Intrinsic

Cognitive Behavior Therapy for insomnia consists of stimulus control therapy, sleep restriction therapy, cognitive therapy and relaxation.

The program consists of three primary components: theoretical material related to relaxation, meditation, and the mind-body connection; experiential practice of meditation and yoga and home based practice; group process focused on problem solving and support.

This intervention is provided over the course of eight, weekly, 90 minute sessions, plus one 6 hour silent retreat.

Mindfulness-Based Stress Reduction

This treatment is delivered to small groups over the course of 8 weekly, 90 minute sessions

Cognitive Behavior Therapy

Tavis S Campbell, PhD

Sleep disturbance in cancer patients is often overlooked despite its documented high prevalence and negative impact. There are few empirically validated non-pharmacological treatments for insomnia and many patients are unwilling to rely on sleeping medications. This study will determine whether Mindfulness-Based Stress Reduction (a program that teaches meditation and yoga) produces equivalent results with the additional benefits of reduced stress and mood disturbance, to an already established treatment for insomnia, Cognitive-Behavioral Therapy. This will allow for the expansion of treatment options for insomnia beyond what is currently available and improve quality of life for millions of cancer survivors.

A Comparison of MBSR and CBT for the Treatment of Insomnia in Cancer

An Objective Comparison of Cognitive Behavioral Therapy and Mindfulness-based Stress Reduction for the Treatment of Insomnia in Cancer Survivors Using Wrist Actigraphy: A Randomized Noninferiority Trial

Canadian Cancer Society (CCS)

University of Calgary

Associate Professor of Psychology

Digestive System Diseases

Occupational Diseases

Depressive Disorder

Colorectal Neoplasms

Depressive Disorder, Major

Depression

Sleep Disorders, Circadian Rhythm

Behavioral Symptoms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Chronobiology Disorders

Quality of Life

Herbal and Botanical

Cola

All patients eligible for elective curative intended surgery for colonic adenocarcinoma at Zealand University Hospital.

Patients will recieve treatment as per standard of care.

Elective radical surgery for adenocarcinoma.

Standard of care

Michael T Madsen, M.D.

Objective The objective of the current trial is to investigate the effect of perioperative sleep and circadian rhythm on the natural course of survival among patient diagnosed with colorectal cancer. Concurrently, outcome measures like depression, fatigue, quality of life, and co-morbidity will be measured continuously in the short-, intermediate- and long-term period following diagnosis.

The a-priori hypothesis is that preoperative sleep and circadian disturbances is a prognostic marker of reduced overall survival. Likewise, preoperative sleep-wake disturbances at baseline are expected to result in overall universally reduced quality of life, increased depression and fatigue. Furthermore, development of sleep-wake disturbances in the postoperative period as compared to preoperative sleep-wake rhythm is expected to a prognostic marker of negative outcomes.

Target and study population The study population are all patients diagnosed with colorectal cancer in Region Zealand recruited consecutively from the trial initiation until study end each patient with an intended 5 year follow-up period. All available cases will be included in the trial.

Study design The study will be an observational prospective cohort study applying a longituditional repeated measure design.

Exposures and outcomes of interest The primary outcomes in the trial are sleep and circadian outcomes measured via actigraphy in the perioperative period.

Furthermore, cancer related survival and overall survival in the 5 year follow-up period is considered primary outcomes.

Secondary outcomes consist of consecutively measured depression, fatigue, quality of life, follow-up treatment and co-morbidity.

Exposure variables are primary related to the cancer, i.e. cancer stage, surgical treatment, oncological treatment, baseline co-morbidity and pharmacological treatment. Some of the secondary outcomes could be expected to serve as confounding or mediating factors.

Meaningful control for confounding will in the analysis phase be cancer stage and baseline sleep-wake rhythm status.

Sampling methods All available cases will be sought included in the trial. No formal sample size has been performed and continues inclusion into the trial will be performed during an 1,5 year period.

Statistical analyses The relationship between overall survival and baseline sleep-wake rhythm will be investigated using survival statistics and/or multivariate logistic regression.

Expected results The investigators expect to see a marked difference in overall survival among patients with sleep and circadian disturbances at baseline.

Sleep and Survival in Colorectal Cancer

Sleep-wake Rhythm in the Perioperative Period in Patients Admitted for Elective Radical Surgery for Colorectal Cancer: an Observational Prospective Cohort Study.

Contact to study investigators avaliable at mitm@regionsjaelland.dk

Assessment of activity using accelerometor - Sleep and circadian assesment.

Baseline registration and follow-up assessments

Center of Surgical Science, Department of Surgery, Zealand University Hospital

Zealand University Hospital

M.D.

Derk-Jan Dijk

Andrew Davies

Shuchita D Patel

This study evaluates the use of actigraphy-derived measures to improve prognostication in patients with advanced cancer.

An accurate assessment of prognosis (life expectancy) is important for cancer patients, their carers, and their health care professionals. In the case of patients / their carers, it allows them to plan for the future, and to make more informed decisions about further anti-cancer treatments, and about referral to supportive and palliative care services. However, previous research suggests that health care professionals are not particularly good at estimating prognosis, and frequently over-estimate prognosis.

The aim of this project is to assess the usefulness of measuring physical activity, and differences between daytime and nighttime physical activity, in determining prognosis in patients with cancer. Studies suggest that these measures may be useful in determining prognosis in certain groups of patients with cancer (e.g. patients receiving chemotherapy for colon / rectum cancer). However, these studies need to be repeated in patients with different types of cancer, and also patients receiving other types of treatment (including supportive and palliative care). The aim of this small scale ("feasibility") study is to determine whether or not a large scale ("definitive") study can be done.

The feasibility study will include 50 patients with cancer, who will be asked to rate their performance status (physical activity) on a well-used scale, and then to wear a watch-like device for one week that measures physical activity and sleep patterns. The researcher will collect a blood sample: some of which will be used for analysis of parameters, which have previously been identified as prognostic indicators and will collect and store some blood for future transcriptome analysis. Participants will also be asked to complete a sleep diary during the week, and a questionnaire about their symptoms at the beginning and end of the week. The study will last one week in total and is collaboration between the Royal Surrey County Hospital, and the University of Surrey (Surrey Sleep Research Centre).

On first visit (Day 1 of the study), the researcher will collect total 7.5mls (1½ teaspoons) of blood from a vein in the participant's arm. 5 mL of the venous blood sample will be sent for analysis at the Royal Surrey County Hospital of haematological and biochemical parameters, i.e. white blood cell count (WBC), neutrophil count, lymphocyte count, platelet count, urea, alanine aminotransferase (ALT), alkaline phosphatase (ALP), albumin, C-reactive protein (CRP). 2.5 mL of the venous blood sample will be sent for bio-banking at the Surrey Clinical Research Centre at the University of Surrey (for future transcriptome analysis i.e. RNA analysis.

A Feasibility Study of the Use of Actigraphy to Determine Prognosis in Patients With Advanced Cancer

Parameters during the presumed sleep phase of the circadian cycle; eg: Time in bed, sleep efficiency e.t.c

Physician's assessment of the patient's ECOG-Performance Status. The Eastern Cooperative Oncology Group performance scale (ECOG-PS) is a standardised measure for quantifying the functional status of patients with cancer and includes a numerical / categorical scale

Patient's assessment of their own ECOG-Performance Status

The MSAS-SF is a validated symptom assessment tool that has been used extensively in oncology / palliative care research and includes questions on both physical and psychological symptoms.

This is a validated, self-rated questionnaire, which measures sleep quality and disturbances over a 1-month time period

Compare actigraphy-derived circadian / sleep parameters against other validated prognostic indicators

Compares the amount of activity of the patient when in bed to when the patient is out of bed. An actigraphy-derived percentage of the activity counts, measured when the patient is in bed, that are inferior to (lower than) the median of the activity counts measured when the patient is out of bed.

An actigraphy-derived 24hr correlation coefficient that reports on how reproducible the patient's activity is every 24 hours.

calculated as the average number of wrist movements per minute throughout the recording time

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fatigue, Sleep and Cytokines in Primary Brain Tumor (PBT) Patients	NCT00876499	Brain Cancer	Questionnaire	18 Years -	M.D. Anderson Cancer Center
Examining the Relationships Between Sleep, Fatigue, and Pain in Aromatase Inhibitor-treated Patients	NCT01983995	Breast Cancer		50 Years -	University of Michigan
Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)	NCT03326765	Sleep Disorder	Questionnaires electroencephal... polysomnography Actigraphy	1 Day - 70 Years	Universitair Ziekenhuis Brussel
A Comparison of MBSR and CBT for the Treatment of Insomnia in Cancer	NCT01335776	Cancer Insomnia	Mindfulness-Bas... Cognitive Behav...	18 Years -	University of Calgary
Sleep and Survival in Colorectal Cancer	NCT03254836	Colorectal Neop... Circadian Rhyth... Depression Quality of Life Sleep	Standard of car...	18 Years -	Zealand University Hospital
A Feasibility Study of the Use of Actigraphy to Determine Prognosis in Patients With Advanced Cancer	NCT03283683	Cancer Sleep		18 Years -	Royal Surrey County Hospital NHS Foundation Trust
Examining the Relationships Between Sleep, Fatigue, and Pain in Aromatase Inhibitor-treated Patients	NCT01983995	Breast Cancer		50 Years -	University of Michigan

Spots Global Cancer Trial Database for actigraphy

Every month we try and update this database with for actigraphy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for actigraphy

Every month we try and update this database with for actigraphy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for actigraphy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.