Symptoms and General Pathology

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Fatigue

Parasomnias

Lung Neoplasms

Dyssomnias

Chronobiology Disorders

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week.

Exposure to dim light delivered with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week.

Morning bright light therapy

Exposure to dim light with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week.

Dim light

Carleara Ferreira da Rosa Silva, MS, RN

Grace E Dean, PhD

The purpose of this study is to determine the effects of morning bright light therapy on fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.

A randomized controlled trial to test the effects of morning bright light therapy on fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.

Effects of Bright Light Therapy on Fatigue, Sleep and Circadian Activity Rhythms in Lung Cancer Survivors

Visual acuity data will be collected and save for safety purposes only at pre-test and post-test.

Daytime Sleepiness will be assessed for safety purposes only at pre-test, intervention and post-test. Individuals with high daytime sleepiness and/or at risk of falling asleep while driving or performing hazardous activities will be referred out to primary care

Comparison of fatigue severity from pre-test to post-test.

Comparison of Sleep Quality from pre-test to post-test.

Comparison of insomnia from pre-test to post-test.

Circadian Activity Rhythms will be assessed with actigraphy during the 5-week time frame.

Chronotype will be assessed at baseline for a descriptive analysis.

Exposure to environmental light will be assessed at pre-test, intervention and post-test for a descriptive analysis

Quality of Life will be assessed before, during, and after the intervention.

Oncology Nursing Society

State University of New York at Buffalo

Anxiety Disorders

Depressive Disorder

Depression

Quality of Life

Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.

Daily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.

30 minutes every day for 14 days. After enrollment on day 0, blinded phase of study intervention (i.e. daily bright light or red light) from day 1 to day 14+/-3, then proceed to the open label phase and receive daily bright light between day 15+/-3 and day 28+/-3.

Bright Light Therapy

From day 1 to day 14+/-3, daily dim red light therapy for 30 minutes for 14 days where red light device accounts for placebo of the blinded phase of study intervention, then between day 15+/-3 and day 28+/-3 open label phase with daily bright light.

Dim Red Light Therapy

Questionnaires

Study Diaries

Control red light device produced by Litebook identical in appearance and dimensions to the bright light device, with the exception it emits at wavelength 680nm (i.e. red light) and at an intensity of 50 lux.

Red Light Litebook

Bright light device consists of 60 LEDs with spectral emission peak at approximately 464nm and fluorescent phosphors which provide a broader, secondary spectral peak near 564nm. Collectively the emitted light appears white.

Bright Light Litebook

Rony Dev, DO

The goal of this research study is to learn if a type of light therapy can be used to help patients with advanced cancer who are having difficulty sleeping to sleep better.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to one of two groups:

* Group 1 will receive one type of light therapy for 30 minutes every day for 14 days.
* Group 2 will receive a placebo light for 30 minutes every day for 14 days. The placebo light is not designed to have any effect on your sleep.

You will not know which group you are in. After 14 days, both groups will begin receiving the light therapy for another 14 days.

Litebook:

You will use a device called a Litebook to receive either the light therapy or the placebo light for 30 minutes, within 2 hours of waking up every day. The Litebook is about the size of a deck of cards. To use the Litebook, you will place it on a table within 2 feet of you while you are sitting down. The Litebook will either deliver the light therapy or the placebo light. You do not need to look directly into the Litebook and you can do usual activities such as eating or reading while you are using it. The study staff will teach you how to use the Litebook.

Study Diaries:

You will complete the following diaries at the end of each day of the 28-day study period:

* The light exposure diary about how much light you were exposed to.
* The sleep diary about your sleeping habits.

It should take about 5 minutes each day to make entries in the study diaries. You will return the diaries to the study staff at 2 weeks and 4 weeks.

You will also wear a watch that will measure your activity level for 24 hours a day while you are on study. You will return the watch to the study staff after you have completed the study.

Questionnaires:

You will complete a questionnaire about any symptoms you are having from the light therapy at the beginning of the study, at 1 week, at 2 weeks, and at 4 weeks. The questionnaire at 1 week can be done over the phone. It should take about 5 minutes to complete.

You will complete the following questionnaires at the beginning of the study, at 2 weeks, and at 4 weeks:

* The Edmonton Symptom Assessment Scale. You will rate 10 symptoms such as tiredness, shortness of breath, pain, and nausea.
* The FACIT-F questionnaire about how well you are able to perform the normal activities of daily living, your quality of life, and how tired you are.
* The HADS questionnaire about your mood.
* The Pittsburgh Sleep Quality Index about your sleep quality, how long you sleep, and any difficulties you are having when you are trying to sleep.

It should take about 25 minutes to complete all of the questionnaires.

Length of Study:

You will be on study for 28 days.

This is an investigational study. The use of light therapy in patients with difficulty sleeping is investigational. It is currently being used for research purposes only.

Up to 152 patients will take part in this study. All will be enrolled at M. D. Anderson.

The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer

Pittsburgh Sleep Quality Index (PSQI) measured at baseline and two weeks. The PSQI is a validated tool for insomnia, an effective instrument for measuring the quality and patterns of sleep using a 19-item questionnaire. It differentiates "poor" from "good" sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. Each area is rated from 0-3 with the higher score reflecting more severe sleep complaints. The addition of all scores permits the analysis of the participant's overall sleep experience. The PSQI global score ranges from 0 to 21, with a score of 5 or greater indicating significant sleep disturbance.

M.D. Anderson Cancer Center

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Rony Dev, DO/Associate Professor, Palliative Care Medicine

Due to low enrollment and participation data was not collected for analysis.

Effect of Bright Light Therapy on Sleep Disturbances Compared to Dim Red Light in Patients With Advanced Cancer Followed at a Palliative Care Outpatient Clinic at a Comprehensive Cancer Center

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Inflammatory Agents

All Drugs and Chemicals

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Simple stretching exercises, specific breathing skills, and guided relaxation for 3 sessions, 3 times a week for 6 weeks. Each session should last about 60 minutes. Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study. 4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

Participants in this group given the option to take part in one of the two forms of relaxation (off study) after they finish their last questionnaire packet. 4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

3 times a week, 60 minute sessions for 6 weeks.

Relaxation Program

Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study.

4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

Saliva Testing

Lorenzo Cohen, PHD

The goal of this behavioral research study is to compare two different forms of relaxation programs that will include stretching and relaxation techniques, in order to learn if and how well they may help to improve physical and emotional well-being. This will be tested in patients with breast cancer who are receiving radiation therapy. For comparison purposes, there will also be a group of participants that does not take part in the relaxation programs.

This is an investigational study. The relaxation programs are being compared for research purposes only.

An "assessment" is any time you complete a set of scheduled activities for this study, such as tests and questionnaires.

Up to 700 patients will take part in this study. All will be enrolled at MD Anderson.

During the first visit, you will fill out questionnaires that ask about your sleeping habits, how you have been feeling, and the general quality of your life. This should take about 60-80 minutes.

Every day for the next 7 days, you will fill out a diary about your sleep. You will also wear an "actigraph" wrist watch 24 hours a day for these 7 days. The watch will collect data about your physical activity and sleeping habits.

You will also have an electrocardiogram (ECG - a test to measure the electrical activity of your heart) which will last about 10 minutes.

Study Groups:

After your first visit, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups:

* Group 1 will take part in one type of relaxation program.
* Group 2 will take part in another type of relaxation program.
* Group 3 will not take part in either program but will complete some of the follow-up procedures. Participants in this group will be given the option to take part in one of the two forms of relaxation (off study) after they finish their last questionnaire packet.

You will have about a 1 out of 3 chance of being assigned to each group. The groups are randomly assigned, but it is also based on other factors such as your age and the status of the disease.

Sessions:

Groups 1 and 2:

You will take part in 3 sessions each week for the 6 weeks of radiation therapy, or 4-5 sessions each week for 4 weeks if your radiation therapy lasts only 4 weeks. You can choose any weekday (Monday through Friday). Each session should last about 60 minutes.

The sessions will be taught by an experienced, trained instructor, usually in groups of 2-5 participants. The movements are designed to be easy to follow. You will be able to work at your own pace.

Each session will be audio and video recorded. This is so the researchers can keep track of the quality of the sessions. The audio and video files are digital and will be deleted after all the data are studied.

Women in Groups 1 and 2 will be randomized to a maintenance intervention arm or a usual contact arm after the end of radiotherapy. If you are randomized to the maintenance intervention arm you will receive telephone counseling once a month after the end of your radiotherapy. You will also receive booster sessions once every 3 months post-radiotherapy, or at least when you come for your follow-up appointments.

Groups 1 and 2:

During the sessions, you will do simple stretching exercises, specific breathing skills, and guided relaxation. You will be asked to try and practice once a day for 12 months. You will be provided a DVD and an audio CD to help with your practice when you are not at the hospital.

Questionnaires and Study Procedures:

Groups 1 and 2:

Before your first session of the week except for week 1, Groups 1 and 2 will fill out a questionnaire about the relaxation program. This should take about 1-2 minutes.

During the middle of your radiation treatment period, you will have an ECG recorded before and after your classes. Each ECG will last about 10 minutes.

All Groups:

During the middle of your radiation treatment period, you will fill out a questionnaire that asks about any symptoms you may be having. This should take about 15 minutes. You will also have an ECG.

During your last week of radiation therapy, and at 3, 6, and 12 months after your radiation therapy ends, you will fill out a set of questionnaires. The questionnaires will be mostly the same as at your first study visit. This should take about 60-80 minutes. You will also have an ECG at these times.

Questionnaire packets will be mailed to your home by the research staff. After completing the questionnaires, you will return the completed questionnaire packet to the research staff via a pre-paid mailing envelope.

Every day for 7 days in a row, after every time you fill out the questionnaires, you will fill out another sleep diary. During these 7-day periods, you will wear an actigraph watch 24 hours a day to collect the same data as before. Each time, you will mail the actigraph watch back to MD Anderson in postage-paid envelopes that will be provided to you.

If your questionnaire responses show that you may be having emotional difficulties or depression, you will be provided with names of mental health providers in case you would like to receive mental health screening.

All participants will be asked not to do any other stretching/relaxation practices during the study.

Saliva Testing:

You will provide 4 saliva samples per day for cortisol testing on the following schedule:

* for 3 days before radiation therapy begins
* for 3 days in the last week of radiation therapy
* for 3 days in a row, 3 months after radiation therapy ended
* for 3 days in a row, 6 months after radiation therapy ended
* for 3 days in a row, 12 months after radiation therapy ended

To provide a saliva sample, you will chew on a cotton ball for a few seconds and then put the cotton in a small plastic tube. You will then mail the samples back to MD Anderson in postage-paid envelopes that will be provided to you. The tubes will also be provided at no cost to you. These saliva samples will be destroyed after being studied.

Length of Participation:

Your study participation will be over after you fill out the questionnaires 12 months after radiation therapy.

Relaxation for Women With Breast Cancer Undergoing Radiotherapy

Biobehavioral Effects of Relaxation for Women With Breast Cancer Undergoing Radiotherapy

Effectiveness of 6-week relaxation intervention evaluated by physical component scale scores during and after treatment, defined as Medical Outcomes Study 36-item short-form survey (SF-36).

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Behavioral Symptoms

Mood Disorders

Central Nervous System Depressants

Other Dietary Supplements

Melatonin

Antioxidants

Protective Agents

6 mg oral melatonin daily 1 hour before bedtime

Melatonin (N-acetyl-5-methoxytryptamine)

6 mg oral placebo daily 1 hour before bedtime

Placebo

Melissa V Hansen, MD

The purpose of this study is to investigate the effect of 6 mg melatonin daily for 1 week preoperatively to 12 weeks postoperatively on depressive symptoms, anxiety, cognitive function and sleep disturbances in breast cancer patients. Furthermore the investigators will examine whether a specific clock-gene (HPER3) is correlated with an increased risk of depression, sleep disturbances or cognitive dysfunction.

About 1.4 million women are diagnosed with breast cancer every year. Breast cancer is the most common malignancy among women worldwide constituting about 1/5 of all cancer types. Breast cancer diagnosis and treatment, and the months following primary therapy are stressful times for most women. Aside from the actual "cancer threat" many women experience various degrees of depression, anxiety, sleep disturbances and memory/concentration problems (cognitive dysfunction). Naturally these factors influence the quality of life but also contribute to morbidity and mortality.

Melatonin is a regulatory circadian hormone having, among others, hypnotic, sedative, anxiolytic and possibly anti-depressive effects. It has very low toxicity and very few adverse effects.

The purpose of this project is to test melatonin (6 mg daily for 1 week preoperatively to 12 weeks postoperatively) on breast cancer patients and hopefully hereby be able to prevent depression, anxiety, sleep disturbances and cognitive dysfunction. On an overall perspective this will hopefully contribute to improving the quality of life for these patients and extend their lifetime. Furthermore the investigators will be examining whether a specific gene called a clock-gene (HPER3) is correlated with an increased risk of depression, sleep disturbances or cognitive dysfunction. If this is the case it could become possible to identify women with an increased risk and provide prophylactic treatment for those with a risk of developing a depression, sleep disturbances or cognitive disturbances.

Sample size calculations were based on our primary outcome parameter. Using a conservative estimate for the incidence of depression, the investigators expect to find a reduction from 30% to 15% with melatonin treatment. Sample size is sufficient to include our secondary and tertiary outcome parameters as well. The sample size calculations were calculated with a power of 80%, a type I error of 5% and a type II error of 20%.

The Effect of Melatonin on Depression, Anxiety, Cognitive Function and Sleep Disturbances in Breast Cancer Patients

MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.

For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.

Diagnostic scale using the ICD-10 algorithm:

Mild depression: 2 core symptoms and 2 other symptoms Moderate depression: 2 core symptoms and 4 other symptoms Severe depression: 3 core symptoms and 5 other symptoms

Rating scale:

No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50

MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.

For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.

Rating scale:

No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 This analysis includes only patients who have taken study medication as planned.

MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.

For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.

Rating scale:

No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 For this analysis all missing MDI data have been analyzed as "NO" depression.

MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.

For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.

Rating scale:

No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 For this analysis all missing MDI data have been analyzed as "YES" for depression.

Anxiety measured by VAS (visual analog scale). A subjective feeling of anxiety was registered on a VAS going from "no anxiety", equivalent to 0mm to "worst possible anxiety", equivalent to 100mm.

Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.

Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 2 %

Anxiety measured by VAS (visual analog scale). Completed every 14th day. A subjective feeling of anxiety was registered on a VAS going from "no anxiety", equivalent to 0mm to "worst possible anxiety", equivalent to 100mm.

Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).

Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 1 %

Sleepiness measured by Karolinska Sleepiness Scale. KSS is a 9-point scale from 1 (very awake) to 9 (very sleepy) where a score of 7 or more reflects pathological sleepiness.

Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.

Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 2 %

Sleepiness measured by Karolinska Sleepiness Scale. KSS is a 9-point scale from 1 (very awake) to 9 (very sleepy) where a score of 7 or more reflects pathological sleepiness.

Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).

Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 1 %

Fatigue on a Visual Analog Scale - filled out daily. A subjective feeling of fatigue was registered on a VAS going from "no fatigue", equivalent to 0mm to "worst possible fatigue", equivalent to 100mm.

Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.

Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 2 %

Fatigue on a Visual Analog Scale - filled out every 14th day. A subjective feeling of fatigue was registered on a VAS going from "no fatigue", equivalent to 0mm to "worst possible fatigue", equivalent to 100mm.

Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).

Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 1 %

General well-being on a Visual Analog Scale - filled out daily. A subjective feeling of general well-being was registered on a VAS going from "very high well-being", equivalent to 0mm to "very low well-being", equivalent to 100mm.

Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.

Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 2 %

General well-being on a Visual Analog Scale - filled out every 14th day. A subjective feeling of general well-being was registered on a VAS going from "very high well-being", equivalent to 0mm to "very low well-being", equivalent to 100mm.

Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).

Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 1 %

Pain on a Visual Analog Scale - filled out daily. A subjective feeling of pain was registered on a VAS going from "no pain", equivalent to 0mm to "worst possible pain", equivalent to 100mm.

Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.

Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 2 %

Pain on a Visual Analog Scale - filled out every 14th day. A subjective feeling of pain was registered on a VAS going from "no pain", equivalent to 0mm to "worst possible pain", equivalent to 100mm.

Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).

Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 1 %

Subjective sleep score on Visual Analog Scale. Subjective sleep quality was registered on a VAS going from "best possible sleep", equivalent to 0mm to "worst possible sleep", equivalent to 100mm.

Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.

Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 2 %

Subjective sleep on a Visual Analog Scale. Subjective sleep quality was registered on a VAS going from "best possible sleep", equivalent to 0mm to "worst possible sleep", equivalent to 100mm.

Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).

Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF \< 1 %

Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings). A wrist actigraph will be worn from inclusion till 14 days postoperatively.

A blood sample will be taken at inclusion and analysed for HPER3 genotype (4/4, 4/5, 5/5) and this will be investigated for a correlation with sleep, cognitive function and depressive symptoms 7 patients did not give blood samples

Calculations for POCD were based on normative data from 133 females aged 40-60 years. We evaluated changes from the preoperative baseline to the 2 postoperative test sessions. In controls we calculated mean and standard deviations (SD) of these differences. The mean change in this group may be taken as estimated learning effects. For the individual patients, we compared baseline scores with the 2- and 12-week postoperative test results, subtracted the average learning effect from the changes and divided the result by the SD of the control group to obtain a Z score for the 7 individual test outcomes. A large positive Z score indicated deterioration in cognitive function from baseline in patients. We defined a composite Z score as the sum of the 7 Z scores and normalized this using the SD for that sum in the controls. POCD was defined as a combined Z score \>1.96 or a Z score \>1.96 in at least 2 of the 7 subtests.

Units of measure = % of patients with YES to POCD

University of Copenhagen

Rigshospitalet, Denmark

Pharma Nord

Melissa Voigt Hansen

M.D., ph-D student

Only includes patients who have at least taken 1 dose of the study drug.

Age, Categorical

Denmark

Mastectomy + axillary dissection +/- SN

Mastectomy + SN

Lumpectomy + axillary dissection +/- SN

Lumpectomy + SN

Lumpectomy converted to mastectomy + SN

Bilateral lumpectomy + axillary dissection + SN

Type of surgery

Surgery duration

Anaesthesia duration

None

Radiation

Chemotherapy

Chemotherapy + radiation

Radiation x 1 only

Drop-out before chemo/radiation

Only registered as which oncological treatment (if any at all) the patients received during their participation in the MELODY trial

Oncological treatment

Drop-out before anti-hormone therapy

Only registered as which anti-hormone therapy (if any at all) the patients received during their participation in the MELODY trial

Anti-hormone therapy

The MDI is a self-rating scale including 12 questions and has been validated in a Danish population. The MDI assesses information on depressive symptoms that have been present continuously during the previous 2 weeks. The individual items are measured on a 6-point Likert scale, ranging from 0 to 5, with graduations depending on the extent of the symptom the previous 14 days. Accordingly, the theoretical score ranges from 0 to 50.

MDI - Major Depression Inventory

Premenopausal

Postmenopausal

Menopausal status

Premature termination (54/260). Only included about 8% (54/703) of the patients assessed for eligibility.

MD Melissa Voigt Hansen

Includes all patients who have completed at least one other MDI than baseline

Major Depression Inventory (MDI)- Depression at One Point in the Study

Includes only patients who have taken the study medication as planned

Per Protocol - Depression at One Point in the Study Period

All missing MDI data have been analyzed as "NO" depression.

Intention to Treat (Underestimate) - Depression at One Point in the Study Period

All missing data have been analyzed as "YES" depression.

Intention to Treat (Overestimate) - Depression at One Point in the Study Period

Area Under the Curve (AUC) for VAS Data on Anxiety - Immediate Postoperative Period

Patients were only included in the analysis if they had completed VAS on anxiety in the long-term postoperative period. Single missing data were filled out using last observation carried forward.

Area Under the Curve (AUC) for VAS Data on Anxiety - Long-term Postoperative Period

Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Immediate Postoperative Period

Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Long-term Postoperative Period

Area Under the Curve (AUC) for VAS Data on Fatigue - Immediate Postoperative Period

Area Under the Curve (AUC) for VAS Data on Fatigue - Long-term Postoperative Period

Patients were only included in the analysis if they had completed daily VAS on anxiety for at least 8 days postoperatively. Single missing data were filled out using last observation carried forward.

Area Under the Curve (AUC) for Data on General Well-being - Immediate Postoperative Period

Area Under the Curve (AUC) for VAS Data on General Well-being - Long-term Postoperative Period

Area Under the Curve (AUC) for VAS Data on Pain - Immediate Postoperative Period

Area Under the Curve (AUC) for VAS Data on Pain - Long-term Postoperative Period

Area Under the Curve (AUC) for VAS Data on Sleep Quality - Immediate Postoperative Period

Area Under the Curve (AUC) for VAS Data on Sleep Quality - Long-term Postoperative Period

Sleep Architecture

4/4 genotype

4/5 genotype

5/5 genotype

Missing

HPER3 Genotype

Analysis includes only patients who completed all parts of the neuropsychological test battery at baseline and 2 weeks postoperatively.

Incidence of Postoperative Cognitive Dysfunction (POCD) App. 2 Weeks Postoperatively.

Analysis includes only patients who completed all parts of the neuropsychological test battery at baseline and 10 weeks postoperatively.

Incidence of Postoperative Cognitive Dysfunction (POCD) App. 10 Weeks Postoperatively

12 weekly 60-minute yoga classes taught by a certified yoga instructor with cancer-specific yoga training that will commence concurrently with the start of chemotherapy.

12 weekly 60-minute yoga classes taught by a certified yoga instructor with cancer-specific yoga training that will commence 3 months after start of chemotherapy

The intervention will consist of 12 weekly 60-minute yoga classes taught by a certified yoga instructor with cancer-specific yoga training. Classes will be conducted at the Beth Israel Comprehensive Cancer Center in a closed-group format, and will be offered twice a week. Yoga mats will be provided for each patient. The maximum number of patients attending each class will be 12. The classes will combine physical postures (asanas), breathing (pranayama), and deep relaxation (savasana). We would also encourage patient to practice yoga at home and keep a diary.

Yoga

Theresa Shao, MD

The primary aim of this study is to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga and those not receiving yoga. Secondary endpoints will include other measures of QOL such as sleep quality measured with the Pittsburg Sleep Quality Inventory (PSQI), anxiety and depression using Hospital Anxiety and Depression Scale (HADS), and adherence to yoga and to chemotherapy treatment.

A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy

A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy: Effects on Quality of Life and Chemotherapy-associated Symptoms

to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga immediately and those start yoga 3 months later.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Bright Light Therapy on Fatigue, Sleep and Circadian Activity Rhythms in Lung Cancer Survivors	NCT02954809	Fatigue Sleep Disturban... Circadian Dysre...	Morning bright ... Dim light	18 Years -	State University of New York at Buffalo
The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer	NCT01193530	Advanced Cancer...	Bright Light Th... Dim Red Light T... Questionnaires Study Diaries Red Light Liteb... Bright Light Li...	18 Years -	M.D. Anderson Cancer Center
Relaxation for Women With Breast Cancer Undergoing Radiotherapy	NCT01202851	Breast Cancer	Relaxation Prog... Questionnaires Saliva Testing	18 Years -	M.D. Anderson Cancer Center
The Effect of Melatonin on Depression, Anxiety, Cognitive Function and Sleep Disturbances in Breast Cancer Patients	NCT01355523	Breast Cancer Depression	Melatonin (N-ac... Placebo	30 Years - 75 Years	Herlev Hospital
A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy	NCT02360904	Fatigue Sleep Disturban...	Yoga	18 Years -	Icahn School of Medicine at Mount Sinai
The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer	NCT01193530	Advanced Cancer...	Bright Light Th... Dim Red Light T... Questionnaires Study Diaries Red Light Liteb... Bright Light Li...	18 Years -	M.D. Anderson Cancer Center
A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy	NCT02360904	Fatigue Sleep Disturban...	Yoga	18 Years -	Icahn School of Medicine at Mount Sinai
A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy	NCT02360904	Fatigue Sleep Disturban...	Yoga	18 Years -	Icahn School of Medicine at Mount Sinai
A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy	NCT02360904	Fatigue Sleep Disturban...	Yoga	18 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for sleep disturbances