This phase II trial tests how well bright white light (BWL) therapy works in reducing cancer-related fatigue and depression in patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment with antiandrogen therapy (ADT) combination therapy. Combination treatment including ADT plus chemotherapy and androgen receptor (AR) targeted therapy or ADT plus AR targeted therapies work by reducing testosterone. Most prostate tumor cells rely on testosterone to help them grow; therefore, ADT combination therapy causes prostate tumor cells to die or to grow more slowly leading to improved overall survival in men with advanced prostate cancer when compared with ADT alone. However, lower levels of testosterone is also commonly associated with worsening fatigue and depression. If prolonged and severe, these complications can alter patient treatment plans, impacting not just quality of life, but leading to inadequate cancer control. BWL therapy is a type of phototherapy that utilizes bright white full-spectrum light, either through a light box or light therapy glasses to help regulate circadian rhythms. Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle, including the sleep-wake cycle which can become disrupted in cancer patients undergoing treatment, leading to increased fatigue. Additionally, exposure to bright light may increase the production of serotonin, a neurotransmitter that is associated with mood regulation. BWL therapy with AYOpro light therapy glasses may serve as a supportive care measure for men with advanced prostate to help reduce fatigue, as well as improve mood and overall quality of life during ADT combination therapy to maintain cancer care without suffering complications of therapy.
PRIMARY OBJECTIVE: I. To evaluate whether patient-reported fatigue by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue instrument at 3 months is lower in men with prostate cancer receiving immediate bright white light therapy as compared with delayed bright white light (BWL) therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT+ hormonal intensification). SECONDARY OBJECTIVES: I. To evaluate the difference in the following outcomes between men with prostate cancer receiving immediate bright white light therapy as compared with delayed bright white light (BWL) therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification): Ia. Mood by the Patient Health Questionnaire (PHQ)-9 instrument measuring depressive symptoms; Ib. Geriatric assessments by the Cancer and Aging Research Group- Geriatric Assessment (CARG-GA) and Geriatric 8 (G8) instruments; Ic. Overall quality of life by the Functional Assessment of Cancer Therapy (FACT)-Prostate (FACT-P) instrument. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (IMMEDIATE): Patients wear AYOpro BWL therapy glasses starting on day 1 of standard of care (SOC) ADT combination therapy for 12 months on trial. GROUP II (DELAYED): Patients wear AYOpro BWL therapy glasses starting 6 months after the start of SOC ADT combination therapy for 6 months on trial. Patients are followed for 52 weeks (total duration of the trial), or for 4 weeks including after removal from protocol therapy or until death, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
210
Wear AYOpro BWL therapy
Receive SOC ADT combination therapy
Ancillary studies
Ancillary studies
Ancillary studies
City of Hope Medical Center
Duarte, California, United States
RECRUITINGChange in patient-reported fatigue
Will compare patient-reported fatigue between men treated with immediate versus delayed bright white light (BWL) therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT+ hormonal intensification). Measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue instrument. T test will be used to compare FACIT-Fatigue change score between two arms (T2 \[3 month after treatment initiation\] minus T1 \[before or at treatment initiation\]).
Time frame: Baseline to 3 months post antiandrogen therapy (ADT) combination treatment initiation
Difference in mood outcomes
Will compare the difference in mood between men with prostate cancer receiving immediate BWL therapy as compared with delayed BWL therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification). Measured by Patient Health Questionnaire (PHQ)-9 instrument measuring depressive symptoms. T test will be used to compare PHQ-9 change score between two arms (T2 \[3 month after treatment initiation\] minus T1 \[before or at treatment initiation\]).
Time frame: Baseline to 3 months post ADT combination treatment initiation
Difference in geriatric assessments
Will compare the difference in geriatric assessments between men with prostate cancer receiving immediate BWL therapy as compared with delayed BWL therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification). Measured by Cancer and Aging Research Group- Geriatric Assessment (CARG-GA) and Geriatric 8 (G8) instruments. T test will be used to compare CARG-GA and G8 change scores between two arms (T2 \[3 month after treatment initiation\] minus T1 \[before or at treatment initiation\]).
Time frame: Baseline to 3 months post ADT combination treatment initiation
Difference in overall quality of life
Will compare the difference in overall quality of life between men with prostate cancer receiving immediate BWL therapy as compared with delayed BWL therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification). Measured by Functional Assessment of Cancer Therapy (FACT)-Prostate (FACT-P) instrument. T test will be used to compare FACT-P change score between two arms (T2 \[3 month after treatment initiation\] minus T1 \[before or at treatment initiation\]).
Time frame: Baseline to 3 months post ADT combination treatment initiation
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