Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Depression

Breast Neoplasms

Anxiety Disorders

Fatigue

Depressive Disorder

Behavioral Symptoms

Quality of Life

Cognitive therapy will involve eight individual weekly sessions of 50 minutes with a Ph.D. student in psychology.

Cognitive therapy of depression

Bright light therapy will consist of a 30-min daily morning exposition to a 10 000-lux BLT lamp during 8 weeks.

Bright light therapy

Josée Savard, Ph.D.

Depressive symptoms are highly frequent among cancer patients. These symptoms significantly impair quality of life (e.g., hopelessness, greater risk of suicidal behaviours) and may even affect patients' prognosis (e.g., through decreased adherence to cancer treatments). Cognitive therapy (CT) is an established treatment for depression in the general population, but its efficacy has not yet been investigated in non-metastatic cancer patients. Furthermore, because the accessibility to CT is very limited in routine cancer care and because many patients are reluctant to use pharmacological treatment, they often turn to alternative treatments such as bright light therapy (BLT), but empirical data on its efficacy are needed before its use can be recommended. Goal 1: To assess at post-treatment, as compared to a waiting-list control condition, the effect of bright light therapy (BLT) and cognitive therapy (CT): (1a) in reducing depressive symptoms; and (1b) in improving subjective and objective sleep parameters, in reducing fatigue and anxiety and in increasing patients' functioning and quality of life. Goal 2: To compare at post-treatment and at 3- and 6-month follow-ups the effect of BLT and CT : (2a) in reducing depressive symptoms; and (2b) in improving subjective and objective parameters of sleep, in reducing fatigue and anxiety and in increasing patients' functioning and quality of life. It is hypothesized that, As compared to control patients after their waiting period, both BLT and CT groups will have significantly greater improvement of all symptoms at post-treatment. However, as compared to BLT patients, CT patients will show greater improvements of all symptoms at post-treatment and at 3- and 6-month follow-ups. This study will provide empirical data on the efficacy of two approaches for treating depressive symptoms in cancer patients in order to better inform the scientific community, health care providers, and patients on the most effective depression treatments to implement in cancer care.

Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Cognitive Therapy and Bright Light Therapy

Canadian Institutes of Health Research (CIHR)

CHU de Quebec-Universite Laval

Professeure titulaire/Chercheuse

Nervous System Diseases

Parasomnias

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

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

Chronobiology Disorders

Single arm study receiving a multi-modal intervention

A psychoeducational and evidence-based skills and strategies course for insomnia delivered online over four lessons through ThisWayUp. This will be completed during an 8-week feasibility trial.

Cognitive behavioural therapy for Insomnia (CBT-I)

Daily bright light therapy for 30 minutes on waking delivered using the Lumie-L light box during an 8-week feasibility trial.

An individualised activity plan is created at baseline and adjusted weekly aiming to increased daytime physical activity and reduce sedentary behaviours. The activity plan takes into consideration personal interests, perceived barriers to activity and develops an activity plan using Specific Measureable Achievable Realistic and Timely (SMART) goals. This will take place during an 8-week feasibility trial.

Individualised activity plan

Two clinical reviews will take place during an 8-week feasibility trial and consider uncontrolled symptoms, medication and blood test abnormalities which may impact on rest and physical activity levels

Clincial review

Craig Gouldthorpe

Circadian rest-activity rhythm disorders are common in patients with cancer, particularly in advanced disease. A recent international e-Delphi study has outlined recommendations for the assessment and reporting of the disorder and subsequently an observation study is underway assessing a cohort of patients with advanced cancer. Affected patients are eligible to enter a feasibility study assessing a non-pharmacological multi-modal intervention.

A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)

The RALI Study: a Multimodal Non-pharmacological (Clinical Review, Physical Activity, Bright Light Therapy and Cognitive Behavioural Therapy for Insomnia) Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Patients With Advanced Cancer

Patient completed questionnaire of the acceptability and usability of interventions and research assessments

Patient completed weekly diary of adherence to the interventions and weekly monitoring by the researcher

Number of subjects develop adverse events during the trial in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)

Number of participants completing the midpoint and end of study assessments

Number of participants recruited to the feasibility study over a 1 year period

Memorial Symptom Assessment Score Short Form (MSAS-SF). The scale assesses the presence and level of distress (Not at all, A little bit, Somewhat, Quite a bit, Very much) associated with 32 physical and psychological symptoms. Higher scores suggest increased symptomatology and increased distress

European Organisation for Research and Treatment of Cancer QLQ-C30. Participants rate 28 symptom and quality of life measures on a scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Higher scores suggest a worser outcome. Participants also rate their overall health and quality of life on a scale 1-7 (1 = very poor, 7 = excellent).

Epworth Sleepiness Scale. Participants rate the likelihood of falling asleep in 8 scenarios. Higher scores suggest increased daytime sleepiness

Brief Pittsburgh Sleep Quality Index (bPSQI). Participants complete 6 questions with higher scores suggesting poorer sleep quality.

Physical activity will be captured over a continuous 72-hour period using wrist and thigh accelerometry. Accelerometry devices collect activity counts during 1 minute periods (epochs).

A novel diary will be completed. Daytime physical activity will be assessed (level of tiredness, level of exertion, time spent during different activity intensities). Additional medication, smoking, caffeine and alcohol use will be documented. Nighttime sleep will also be assessed (time in bed, time to lights off, time to fall asleep, waking time, out of bed time, sleep quality).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Cognitive Therapy and Bright Light Therapy	NCT01637103	Treatment of De...	Cognitive thera... Bright light th...	18 Years - 75 Years	CHU de Quebec-Universite Laval
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
Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Cognitive Therapy and Bright Light Therapy	NCT01637103	Treatment of De...	Cognitive thera... Bright light th...	18 Years - 75 Years	CHU de Quebec-Universite Laval
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 Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI)	NCT06329479	Circadian Rhyth... Cancer	Cognitive behav... Bright Light Th... Individualised ... Clincial review	18 Years -	University of Dublin, Trinity College

Spots Global Cancer Trial Database for bright light therapy