Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers
NCT ID: NCT05519878
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
224 participants
INTERVENTIONAL
2022-11-29
2027-05-25
Brief Summary
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Detailed Description
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I. To evaluate patient's fatigue at post-intervention (3 months from baseline).
SECONDARY OBJECTIVE:
I. To evaluate whether the change (improvement) in fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue tool, from pre-interventions to post interventions is significantly different between intervention groups in patients with genitourinary cancers.
THIRD OBJECTIVE:
I. To assess patient perceived changes in occupational performance as measured by the Canadian Occupational and Performance Measure (COPM) tool, in the occupational therapy (OT) group, compared to the control group in patients with genitourinary cancers.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I (Bright white light \[BWL\]): 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.
ARM II (OT): Patients undergo 6 occupational therapist-led sessions over 60 minutes each.
ARM III (BWL and OT): 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.
ARM IV (CONTROL): Patients undergo routine treatment and usual follow up care with their medical oncologist.
After completion of study, patients are follow-up for 3 months.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Bright White Light Therapy
Undergo bright white therapy
Questionnaire Administration
Complete questionnaires
Arm II (OT)
Patients undergo 6 occupational therapist-led sessions over 60 minutes each.
Occupational Therapy
Undergo occupational therapy
Questionnaire Administration
Complete questionnaires
Arm III (OT, 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 and to complete the occupational therapist-led session over 60 minutes.
Bright White Light Therapy
Undergo bright white therapy
Occupational Therapy
Undergo occupational therapy
Questionnaire Administration
Complete questionnaires
Arm IV (Control)
Patients undergo routine treatment and usual follow up care with their medical oncologist.
Best Practice
Undergo routine treatment and usual follow up care
Questionnaire Administration
Complete questionnaires
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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William Dale
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Facility Contacts
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William Dale
Role: primary
Other Identifiers
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NCI-2022-05658
Identifier Type: REGISTRY
Identifier Source: secondary_id
22235
Identifier Type: OTHER
Identifier Source: secondary_id
22235
Identifier Type: -
Identifier Source: org_study_id