Recruiting

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

Sponsor:

City of Hope Medical Center

Code:

NCT05519878

Conditions

Bladder Carcinoma

Genitourinary System Neoplasm

Kidney Carcinoma

Prostate Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Bright White Light Therapy

Occupational Therapy

Questionnaire Administration

Study Details

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.

Conditions

Bladder Carcinoma

Genitourinary System Neoplasm

Kidney Carcinoma

Prostate Carcinoma

Study ID

NCT05519878

Start date

Nov 29, 2022

Status verified date

Dec, 2025

Completion date

May 25, 2027

Anticipated

Primary completion date

May 25, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (BWL)

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.

experimental: Arm II (OT)

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

experimental: Arm III (OT, BWL)

active comparator: Arm IV (Control)

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

Interventions

Best Practice

Undergo routine treatment and usual follow up care

Bright White Light Therapy

Undergo bright white therapy

Occupational Therapy

Undergo occupational therapy

Questionnaire Administration

Complete questionnaires

Primary outcome measure

Functional Assessment of Cancer Therapy - (FACIT) [ Time Frame: At baseline ]
Functional Assessment of Cancer Therapy - (FACIT) [ Time Frame: 6 weeks after baseline ]
Functional Assessment of Cancer Therapy - (FACIT) [ Time Frame: 3 months after baseline ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

William Dale

626-256-4673 wdale@coh.org

Principal Investigator:

William Dale

More Information

Sponsor

City of Hope Medical Center

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2025-12-24.