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Recruiting NCT05519878

NCT05519878 Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers

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Clinical Trial Summary
NCT ID NCT05519878
Status Recruiting
Phase
Sponsor City of Hope Medical Center
Condition Bladder Carcinoma
Study Type INTERVENTIONAL
Enrollment 224 participants
Start Date 2022-11-29
Primary Completion 2027-05-25

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Best PracticeBright White Light TherapyOccupational Therapy

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 224 participants in total. It began in 2022-11-29 with a primary completion date of 2027-05-25.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This clinical trial evaluates light therapy and occupational therapy in improving cancer related fatigue (CRF) patients with genitourinary cancers. Light therapy is a non-pharmacological and evidence-based intervention for managing fatigue in cancer patients. The use of light therapy can provide a low burden, inexpensive, and easy to disseminate intervention approach that can potentially have a larger impact on CRF. In addition, occupational therapy is a standard, but often underutilized, component of the multi-disciplinary approach to cancer care. Using the combination of light therapy and occupational therapy may be effective in CRF management.

Eligibility Criteria

Inclusion Criteria: * Aged 18 and over * Sufficiently fluent in English * 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 * Clinician assessed prognosis of greater than or equal to six months * Willing and independently able to provide consent * Receive a pre-screen FACIT-Fatigue score of less than or equal to 30 Exclusion Criteria: * Severe sleep disorders (e.g. narcolepsy) * Eye Diseases which limit the ability of light to be processed (e.g. untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or other retinal disorder) * Severe psychological impairment (e.g., bipolar disorder or manic episodes) * Current employment in night shift work * Previous use of light therapy to alleviate fatigue or depressive symptoms * Secondary cancer diagnosis within the past 5 years * Plans to travel across meridians during treatment * Pregnancy * Currently recovering from previous eye surgery within the past 6 months that causes eye irritation * Sensitivity to light, epilepsy, or a history of seizures

Contact & Investigator

Principal Investigator

William Dale

PRINCIPAL INVESTIGATOR

City of Hope Medical Center

Frequently Asked Questions

Who can join the NCT05519878 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05519878 currently recruiting?

Yes, NCT05519878 is actively recruiting participants. Visit ClinicalTrials.gov or contact City of Hope Medical Center to inquire about joining.

Where is the NCT05519878 trial being conducted?

This trial is being conducted at Duarte, United States.

Who is sponsoring the NCT05519878 clinical trial?

NCT05519878 is sponsored by City of Hope Medical Center. The principal investigator is William Dale at City of Hope Medical Center. The trial plans to enroll 224 participants.

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