Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Nervous System Diseases

Breast Neoplasms

Syndrome

Inflammation

Depression

Depressive Disorder

Cognitive Dysfunction

Fatigue

Stress, Psychological

Chronobiology Disorders

Behavioral Symptoms

Quality of Life

Ali Amidi, PhD

Lisa M Wu, PhD

Emerging evidence indicates that circadian rhythms may be disrupted following cancer and its treatment, and that circadian rhythm disruption may be an underlying pathophysiological mechanism of cancer- and cancer treatment-related symptoms (CRS) such as fatigue, sleep disturbance, cognitive impairment, and depressed mood. Given the detrimental effect of CRS on cancer survivors' quality of life, and a pressing demand for effective interventions to treat CRS, there is a need for a comprehensive examination of circadian disruption related to cancer and its treatment, and its association with CRS. The study will prospectively examine circadian rhythms and a CRS composite score in recently diagnosed breast cancer patients from prior to surgery or chemotherapy to 12 months later. A matched healthy control group will serve as a comparison.

Saliva samples for melatonin. Blood samples for inflammatory cytokines.

The Role of Circadian Rhythms in Cancer-Related Symptoms

The Role of Circadian Rhythms in Cancer-Related Symptoms: A Prospective Controlled Chrono-Bio-Behavioral Observation Study

A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes

Rest/wake activity recorded with wrist actigraphy

Distal skin temperature recorded with wrist actigraphy

Objective sleep recorded with wrist actigraphy

Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples.

Functional Assessment of Cancer Therapy - Cognitive function issues (FACT-Cog)

Center for Epidemiologic Studies Depression Scale (CESD)

University of Aarhus

Danish Cancer Society

Aarhus University Hospital

Assistant Professor

Receives stress reduction intervention introduction with daily practice

Stress reduction intervention

Lena Jumin Lee (Park), Ph.D.

Background:

- People who have an allogeneic hematopoietic stem cell transplant (HSCT) need help as they recover. Being a caregiver can be stressful to the body and mind. Researchers want to find ways to reduce this stress.

Objective:

- To see how a stress reduction intervention affects the stress levels and health of an HSCT caregiver.

Eligibility:

- Adults age 18 and older who plan to be an active caregiver for a person having their first allogeneic HSCT at the NIH Clinical Center. An active caregiver is someone who will be caring for the person from just before admission for the HSCT until at least 6 weeks after.

Design:

* Participants will be put in either the intervention group or the control group.
* All participants will get the usual caregiver education given to all patients and caregivers having a stem cell transplant at the NIH Clinical Center.
* All participants will have 2 study visits. They will give blood samples. They will have health assessments and brief physical exams. They will fill out study questionnaires and have an exit interview.
* The intervention group will get an MP3 player. It will have an audio file with a stress reduction intervention on it. Participants will do this intervention daily. It takes 20 minutes. They will do gentle stretches and breathing exercises. They will get a diary to track their practice.
* The intervention group also will have follow-up phone calls 2 and 4 weeks after their first clinic visit.
* The person getting the HSCT will not be actively involved in the study.
* The study will last about 2 months....

Millions of Americans provide unpaid care for aging or ill family members and friends. Caregiving for an individual with cancer who is undergoing stem cell transplantation is particularly stressful. The stress of caregiving is associated with many disorders, including sleep disturbances, depression, and anxiety. Although there is good evidence that cancer caregivers experience high levels of stress and stress-related symptoms, few interventions studies have been explored to address this concern in this population.

Stress reduction techniques are important skills for individuals to cope with the stress of cancer caregiving. Mindfulness techniques such as yoga and meditation reduce levels of stress and stress-related symptoms in caregivers. However, many caregivers are reluctant to take time away from the patient to attend to their own health and well-being. Few studies have explored yoga-based stress reduction interventions that can be performed at home or at the patient s bedside.

Based upon our past research examining stress and stress-related symptoms in stem cell transplant caregivers, this study is designed to determine preliminary effectiveness of a yoga-based stress reduction intervention in reducing levels of stress in caregivers during allogeneic hematopoietic stem cell transplant (HSCT). In addition, this study will explorefactors associated with change in caregiver stress and symptoms such as demographics, clinical variables, cardiometabolic and inflammatory markers, and health behaviors.

This study will use a prospective randomized control group design to examine the effects of a six-week yoga-based stress reduction intervention on perceived stress in caregivers of allogeneic HSCT patients. Subjects will be accrued to this protocol if they are a caregiver of an individual undergoing allogeneic HSCT at the Clinical Center, NIH, are greater than or equal to 18 years old, able to read English, stand and sit unassisted, raise arms over head without pain, and able to comprehend the investigational nature of the study. A sample of at least 78 caregivers is needed to adequately evaluate the effectiveness of the intervention.

All caregivers will attend the usual care group education provided at the Clinical Center for transplant caregivers. Caregivers randomized to the intervention group will be scheduled for one session with study personnel to receive a 20 minute audio file of gentle chair yoga poses and guided breath awareness, as well as instructions for performing them, and they will be asked to practice daily. Data, in the form of web-based questionnaires, as well as a physical assessment, demographic interview and blood work will be collected from all study participants at baseline (at or near the time of HSCT) and again at the end of the six-week intervention. There will be no long-term follow-up after the intervention period. Questionnaires include: Caregiver Reaction Assessment, Health-Promoting Lifestyle Profile II, Pittsburgh Sleep Quality Index, Freiburg Mindfulness Scale, PROMIS measures of anxiety, applied cognition, depression, positive affect and well-being, Multidimensional Fatigue Symptom Inventory-Short Form and NIH Toolbox measures of loneliness, self-efficacy, and perceived stress. Subjects will participate in an exit interview at the end of the study and the interventionist will complete a log, based on subject diaries, that tracks subject practice, and discrepancy between planned and actual session date and time. Quantitative analysis techniques will be used in this study.

Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

A Randomized Controlled Trial to Determine the Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients

To examine whether HSCT caregivers participating in a stress reduction intervention demonstrate improvement in certain individual factors (self-efficacy, burden, and mindfulness), psychosocial factors (stress, anxiety, depression, loneliness, positive affect and well-being), behaviors (health behaviors) and symptoms (sleep, fatigue, depression, and cognitive impairment) compared with HSCT caregivers in the control group.

National Heart, Lung, and Blood Institute (NHLBI)

National Institutes of Health Clinical Center (CC)

Nutritional and Metabolic Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Overweight

Obesity

Polycystic Ovary Syndrome

Overnutrition

Nutrition Disorders

Body Weight

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

General stress management and health education

Stress reduction

Stress reduction with Health education

Nazia Raja-Khan, MD

The purpose of this study is to determine the effects of stress reduction on glucose, blood pressure, quality of life and overall health and well-being in overweight or obese women, either with Polycystic Ovary Syndrome (PCOS) or without PCOS (non-PCOS). Stress reduction treatment sessions will include one or more of the following activities: breathing exercises, meditation, stretching exercises or health education activities.

Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)

Stress Reduction for PCOS and Non-PCOS Women

National Center for Complementary and Integrative Health (NCCIH)

Thomas Jefferson University

Milton S. Hershey Medical Center

M.D., Assistant Professor of Medicine, Division of Endocrinology, Diabetes, and Metabolism

Anxiety Disorders

Mindfulness-based breathing and music therapy

60 patients in the mindfulness-based breathing and music therapy group were divided into subgroups of 5 participants each. Each 6-person group started by having participants complete the pretest State Anxiety Inventory, Beck Depression Inventory, and Psychological Well-Being Scale via Survey Monkey. Mindfulness-based breathing and music therapy was applied to each patient group in approximately 45-minute sessions per day. At the end of the session, participants re-filled the posttest State Anxiety Inventory, Work-Related Tension Scale, and Psychological Well-Being Scale. A total of 3 sessions were completed with an interval of two days.

Mindfulness

Dilek YILDIRIM, Ph.D

Study design A single blinded, randomized controlled experimental design was used. The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials (CONSORT) checklist.

Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in Istanbul/Turkey.

Inclusion criteria; Patients aged 18 and over, volunteering to participate in the study, conscious and without communication problems, who did not take any course or practice (intervention?) on anxiety, tension, depression symptoms and coping with stress were included in the study. Participitants randomised intervention and controlled groups.

Study design A single blinded, randomized controlled experimental design was used. The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials (CONSORT) checklist.

Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in Istanbul/Turkey.

Inclusion criteria; Patients aged 18 and over, volunteering to participate in the study, conscious and without communication problems, who did not take any course or intervention on anxiety, tension, depression symptoms and coping with stress were included in the study.

Sample size and randomization The sample number was calculated using the GPower 3.1.9 version program. At an effect size of 0.5 and an error level of 0.05 \[alpha\], the required sample size was determined to be at least 54 individuals for each group. A power analysis was performed considering the number of samples and the values of the data obtained from a similar study in the literature (Lee et al., 2020). The power of the analysis made with this sample size was determined as 93.1%. Considering the losses during the study, the sample number for each group was determined as 60 people.

The groups of participants who agreed to participate in the study were determined by the program with the randomization URL http://www.randomization.com/. In order to distribute the numbers to the groups, the numbers from 1 to 120 were randomly assigned to the two groups, assuming that set 1 would represent the intervention group and set 2 would represent the control group. In line with the program, the order of the patients forming the sample group was determined by randomization. A total of 130 patients, 65 in the intervention group and 65 in the control group, were included in the study. 5 participants in the intervention group who did not want to participate and died during the study, and 5 participants in the control group who did not want to participate and died during the study were not included in the evaluation. In the study, the results of a total of 120 patients, 60 in the intervention group and 60 in the control group, were analyzed.

Measures/Instruments Participant Information Form, State Anxiety Inventory, Beck Depression Inventory, and Psychological Well-Being Scale were used to collect research data. Survey Monkey was used as the data collection method. The Survey Monkey survey was created, which provides self-access and makes it easier to collect and track data by preventing multiple data entries from the same person. Confidentiality was ensured by completely disabling electronic and IP address registrations to receive anonymous responses.

The Effect of Mindfulnes Program on Stress, Depression and Psychological Well-being in Cancer Patients

The Effect of Mindfulnes Program on Stress, Depression and Psychological Well-being in Cancer Patients: Single Blinded Randomized Controlled Study

This form was developed by the researchers to include the age, gender, marital status, educational status, and treatment method of the participants.

The State Anxiety Inventory was developed by Spielberger et al. in 1970 to determine the state anxiety levels of individuals. Turkish reliability and validity studies of the inventory were carried out by Öner and Le Compte (1983). The State Anxiety Inventory measures anxiety in adults. In the 20-item State Anxiety Inventory, the total score obtained from the four-point Likert-type inventory for each item can vary between 20 and 80. A high score indicates a high level of anxiety, while a small score indicates a low level of anxiety (Spielberger, et al., 1970; Öner \& Le, 1983). Possible scores on the Scale range from 0 to 19 points (interpreted as meaning no state anxiety), 20 to 39 points (mild), 40 to 59 points (moderate), 60 to 79 points (severe), and 80 points and above ( very severe state anxiety).

The scale, which was developed by Diener, Scollon, and Lucas, (2009) to measure the level of psychological well-being, has eight items. It identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life. The Turkish validity and reliability of the scale was made by Telef in 2013. Scale items are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.87. A high score from the scale indicates that the person has good psychological strength.

Beck et al. The validity and reliability study of the scale developed by Hisli in 1988 was carried out by Hisli. It is a depression rating scale consisting of 21 questions in total, evaluated by adding the scores between 0-3 obtained from each answer. Scale in line with the corresponding score intervals; 1-10 normal, 11-16 moderate mood disorder, 17-20 clinical depression; It is grouped as moderate depression between 21-30, severe depression between 31-40, and severe depression between 41-63.

Istanbul Aydın University

Assistant professor Dr.

The intervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, one-hour weekly sessions incorporated into a team's usual work time activities, with four follow-up booster sessions after twelve months.

Behavioral: Team-based intervention

Kerry S Kuehl, MD, PhD

Researchers from Oregon Health \& Science University have developed a science-based, team-centered, scripted peer-taught program for fire fighters improving diet and exercise behavior while reducing injury rates and costs. Those investigators are partnering with local law enforcement agencies in Oregon and SW Washington to adapt, apply and assess this work-based program among a new high risk group to improve the health and safety of law enforcement officers (LEOs). Fire fighters' work structure is a natural fit for a team-centered format, and teammates' social support appeared to partially mediate the intervention's positive outcomes. Although conducive to team formation, LEOs' work lacks the established team structure of fire fighters. This proposal will apply the team-centered intervention to LEOs and in the process, learn more about teams as vehicles of health behavior change, and their relationship with outcomes and other potential mediating variables in a multilevel ecological analytic framework.

Following a 3 month pilot study with four teams, we will enroll 14 precincts and 80 teams (approximately 470 participants) of LEO work groups for a prospective, clustered randomized 2-year assessment of the intervention (40 intervention and 40 testing-only, control-condition teams). Participants will be evaluated at baseline, 12, and 24. Primary study aims are; 1) Implement a randomized controlled efficacy trial of the SHIELD intervention, a peer-led, team-based occupational wellness program, and assess its behavioral and occupational outcomes, 2) Determine relations among variables in the chain from exposure of LEO subjects to specific intervention components to changes in mediating variables to behavior changes and occupational outcomes, and 3) Perform a cost analysis to determine the economic benefit of this LEO worksite health promotion program.

The intervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, one-hour weekly sessions incorporated into a team's usual work time activities, with four follow-up booster sessions after twelve months. The curriculum is designed to build understanding, healthy decision making skills and engender the social support of teammates; its content and scope reflects the core lifestyles activities used with fire fighters, along with adaptations for the needs of LEOs in domains of the team-building, family support and psychological health.

Participant assessments include established survey instruments, physiological measures and selected laboratory parameters of outcomes and potential mediating variables at the individual, interpersonal and organizational levels. Intervention delivery and fidelity will be assessed. Multilevel and latent growth modeling and mediation analyses will be used to assess outcomes and the relationships among variables. At proposal completion there will be an evidenced-based, exportable occupational safety and health program for LEOs. Its critical components will be defined, and its benefits clearly determined.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Role of Circadian Rhythms in Cancer-Related Symptoms	NCT04401189	Breast Cancer Fatigue Cognitive Impai... Sleep Depression Quality of Life Stress, Psychol... Inflammation Circadian Rhyth... Cancer-Related ...		18 Years -	Aarhus University Hospital
Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients	NCT02257853	Stress, Psychol... Caregivers	Stress reductio...	18 Years -	National Institutes of Health Clinical Center (CC)
Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)	NCT01464398	Polycystic Ovar... Overweight Obesity Stress, Physiol... Stress, Psychol...	Stress reductio... Stress reductio...	18 Years -	Milton S. Hershey Medical Center
Stress Reduction for Overweight or Obese Women Either With Polycystic Ovary Syndrome (PCOS) or Without PCOS (Non-PCOS)	NCT01464398	Polycystic Ovar... Overweight Obesity Stress, Physiol... Stress, Psychol...	Stress reductio... Stress reductio...	18 Years -	Milton S. Hershey Medical Center
The Effect of Mindfulnes Program on Stress, Depression and Psychological Well-being in Cancer Patients	NCT05187130	Neoplasms Cancer	Mindfulness	18 Years -	Istanbul Aydın University
The Role of Circadian Rhythms in Cancer-Related Symptoms	NCT04401189	Breast Cancer Fatigue Cognitive Impai... Sleep Depression Quality of Life Stress, Psychol... Inflammation Circadian Rhyth... Cancer-Related ...		18 Years -	Aarhus University Hospital
Safety & Health Improvement: Enhancing Law Enforcement Departments	NCT01279941	Physical Activi... Nutrition Health Promotio... Stress, Psychol... Cardiovascular ... Cancer	Behavioral: Tea...	18 Years - 70 Years	Oregon Health and Science University

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