Nervous System Diseases

Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Parasomnias

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Participants will receive sleep restriction intervention

Sleep restriction

Participants will receive stimulus control intervention

Stimulus control

Participants will receive systematic light exposure intervention

Systematic light exposure

Rina S Fox, PhD, MPH

This purpose of this study is to learn about how to provide treatment to gynecologic cancer survivors who have difficulty sleeping.

This study has two parts.

In Part 1, 15 gynecologic cancer survivors will receive three candidate intervention components known to reduce sleep disturbance (i.e., sleep restriction, stimulus control, systematic light exposure) simultaneously for six weeks. Participants will then complete semi-structured individual interviews to provide feedback about barriers to and facilitators of intervention adherence. Results of Part 1 will inform the design and delivery of the candidate components in Part 2.

In Part 2, a 2\^3 full factorial design will be followed to randomize 80 gynecologic cancer survivors to one of eight six-week intervention conditions reflecting all possible combinations of the three candidate intervention components.

Improving Sleep in Gynecologic Cancer Survivors

The night prior to each assessment participants will collect overnight urine to enable analysis of urinary 6-Sulfatoxymelatonin

Subjectively-reported sleep quality over the past 7 days will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.

Perceived impairment during wake associated with sleep problems over the past seven days will be measured with the PROMIS Sleep-Related Impairment questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.

The 27-item Functional Assessment of Cancer Therapy - General (FACT-G) will measure HRQOL.

The 32-item Memorial Symptom Assessment Scale (MSAS) will evaluate symptom burden.

Symptoms of depression over the past seven days with be measured with the PROMIS Depression questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.

Symptoms of anxiety over the past seven days with be measured with the PROMIS Anxiety questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.

Fatigue over the past seven days with be measured with the PROMIS Fatigue questionnaire. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.

National Cancer Institute (NCI)

University of Arizona

Assistant Professor

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Frailty

All Drugs and Chemicals

Androgens

Androgen Antagonists

Patients wear an Actiwatch for 5 days at baseline, 3 months and 6 months. Beginning 1-4 weeks after first anti-androgen therapy, patients undergo BWL treatment using Luminette glasses for 30 minutes every morning for 3-6 months.

Patients wear an Actiwatch for 5 days at baseline, 3 months and 6 months. Beginning 1-4 weeks after first anti-androgen therapy, patients undergo DWL treatment using Luminette glasses for 30 minutes every morning for 3-6 months.

Actigraph

Questionnaire Administration

Systematic Light Exposure

William Dale

This pilot trial studies how well systemic light exposure works in preventing frailty in older patients with prostate cancer on hormonal therapy. Hormone therapy causes many symptoms of frailty in older men including fatigue, slower time to walk a specified distance, reduced activity levels, loss of lean muscle, and muscle weakness. It is not yet known if systemic light exposure may reduce frailty in older prostate cancer patients.

PRIMARY OBJECTIVES:

I. Determine if bright white light (BWL), compared to dim white light (DWL), significantly prevents frailty development in older prostate cancer (PC) patients following prostate anti-androgen therapy initiation.

II. Determine if BWL, compared to DWL, significantly increases functional performance and physical activity levels, yields significant reductions in fatigue, lowers body mass index (BMI), and reduces weakness in older PC patients following prostate anti-androgen therapy initiation.

EXPLORATORY OBJECTIVE:

I. Examine the feasibility of collecting and storing clinically-usable bio-measures for future analysis in patients at baseline and if available at 6 months, including blood samples (inflammatory markers), and salivary swabs (genetics, genomics, cortisol circadian rhythms).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (BWL): Patients wear an Actiwatch for 5 days at baseline, 3 months and 6 months. Beginning 1-4 weeks after first anti-androgen therapy, patients undergo BWL treatment using Luminette glasses for 30 minutes every morning for 3-6 months.

ARM II (DWL): Patients wear an Actiwatch for 5 days at baseline, 3 months and 6 months. Beginning 1-4 weeks after first anti-androgen therapy, patients undergo DWL treatment using Luminette glasses for 30 minutes every morning for 3-6 months.

Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy

Light Therapy to Prevent Frailty in Older Men With Prostate Cancer on Hormonal Therapy: A Pilot RCT

Blood samples and saliva swaps will be collected for future analysis.

Will be assessed using Short Physical Performance Battery (SPPB). Will be evaluated using a repeated measures mixed linear model.

Will be assessed using SPPB. Will be evaluated using a repeated measures mixed linear model.

Will be measured using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue. Will be evaluated using a repeated measures mixed linear model.

Will be assessed by measuring the waist and hip circumference using a fabric measuring tape to determine the circumference of the waist (centered at the umbilicus) and hip (centered on the greater trochanter). Will be evaluated using a repeated measures mixed linear model.

Muscle weakness will be measured by grip strength. Will be evaluated using a repeated measures mixed linear model.

Will be evaluated using a repeated measures mixed linear model.

Activity counts will be recorded with the Actiwatch Spectrum Plus for five days at each time-point. Will be evaluated using a repeated measures mixed linear model.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Improving Sleep in Gynecologic Cancer Survivors	NCT05044975	Sleep Disturban... Gynecologic Can...	Sleep restricti... Stimulus contro... Systematic ligh...	18 Years -	University of Arizona
Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy	NCT03661437	Prostate Carcin...	Actigraph Questionnaire A... Systematic Ligh... Systematic Ligh...	60 Years -	City of Hope Medical Center

Spots Global Cancer Trial Database for systematic light exposure