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Light Therapy + Occupational Therapy for Genitourinary Cancers

N/A

Recruiting

Led By William Dale

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On active treatment receiving systemic therapy (e.g., chemotherapy, immunotherapy, hormonal therapy, etc.) or radiotherapy

Patients with diagnosis of a genitourinary (GU) cancer (e.g., prostate, kidney, and bladder cancer) who have grade 1 or 2 fatigue based on physician assessment at the time of study entry

Must not have

Severe sleep disorders (e.g. narcolepsy)

Previous use of light therapy to alleviate fatigue or depressive symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks after baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether light therapy and occupational therapy can help improve cancer-related fatigue in patients with genitourinary cancers.

Who is the study for?

This trial is for adults over 18 with genitourinary cancers like prostate, kidney, and bladder cancer who are experiencing mild to moderate fatigue during treatment. They must speak English well enough to consent and have a life expectancy of at least six months. People with severe sleep disorders, psychological impairments, recent eye surgery or diseases affecting light processing in the eyes, sensitivity to light or seizures cannot participate.

What is being tested?

The study is testing whether combining bright white light therapy with occupational therapy can help reduce fatigue in patients undergoing treatment for genitourinary cancers. Light therapy is simple and low-cost while occupational therapy helps manage daily activities; together they might improve energy levels.

What are the potential side effects?

Light therapy may cause eyestrain, headache, irritability or trouble sleeping if used too late in the day. Occupational therapy generally does not have side effects but could potentially lead to muscle soreness from new activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently undergoing treatment such as chemotherapy, immunotherapy, or radiotherapy.

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I have cancer in my urinary system and feel mildly to moderately tired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe sleep disorder like narcolepsy.

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I have used light therapy for fatigue or depression.

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I do not have severe eye conditions that affect my vision.

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I have been diagnosed with another cancer within the last 5 years.

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I had eye surgery in the last 6 months and my eyes are still irritated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional Assessment of Cancer Therapy - (FACIT)

Secondary study objectives

Longitudinal change in FACIT-Fatigue scores

Self-reported occupational performance - Baseline

Self-reported occupational performance - session 6

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (OT, BWL)Experimental Treatment3 Interventions

Patients self-administer 30 minutes of light delivered via light glasses every morning for 3 months. Patients attend 6 follow up sessions to address any questions regarding the wearable light therapy glasses and to complete the occupational therapist-led session over 60 minutes.

Group II: Arm II (OT)Experimental Treatment2 Interventions

Patients undergo 6 occupational therapist-led sessions over 60 minutes each.

Group III: Arm I (BWL)Experimental Treatment2 Interventions

Group IV: Arm IV (Control)Active Control2 Interventions

Patients undergo routine treatment and usual follow up care with their medical oncologist.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bright White Light Therapy

2020

N/A