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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks after baseline
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am currently undergoing treatment such as chemotherapy, immunotherapy, or radiotherapy.
Select...
I have cancer in my urinary system and feel mildly to moderately tired.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks after baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional Assessment of Cancer Therapy - (FACIT)
Secondary outcome measures
Longitudinal change in FACIT-Fatigue scores
Self-reported occupational performance - Baseline
Self-reported occupational performance - session 6
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
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.
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
~80
Occupational Therapy
2011
Completed Phase 3
~1230
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,236 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,974 Total Patients Enrolled
William DalePrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
459 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a severe sleep disorder like narcolepsy.I have used light therapy for fatigue or depression.I am willing and able to agree to participate on my own.I am currently undergoing treatment such as chemotherapy, immunotherapy, or radiotherapy.I do not have severe eye conditions that affect my vision.I am 18 years old or older.I had eye surgery in the last 6 months and my eyes are still irritated.I have been diagnosed with another cancer within the last 5 years.I have cancer in my urinary system and feel mildly to moderately tired.You are sensitive to light or have a history of seizures.If you scored 30 or lower on the pre-screening test for fatigue (FACIT-Fatigue), you cannot participate.You currently work during the night.Your doctor thinks you will live for at least six more months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (BWL)
- Group 2: Arm II (OT)
- Group 3: Arm IV (Control)
- Group 4: Arm III (OT, BWL)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any vacancies for participants in this investigation?
"According to clinicaltrials.gov, this research is not presently enrolling patients. Despite its initial posting on December 15th 2022 and most recent update in October of the same year, no further recruitment has been requested at this time. However, there are 4108 other medical trials that require volunteers right now."
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