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

NCT05519878 | Recruiting DMC FDA Device

• 3 other identifiers: 22235NCI-2022-05658P30CA033572
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Genitourinary System Neoplasm; Prostate Carcinoma; Bladder Carcinoma; Kidney Carcinoma

Outcome Measures

Primary Outcomes (3)

• Functional Assessment of Cancer Therapy - (FACIT)

  The effects of light therapy and occupational therapy (OT) on FACIT will be evaluated by comparing light therapy to no-light therapy and comparing occupational therapy to no-occupational therapy. Analysis of variance test will be used for the factorial comparisons, with a two-sided statistical significance level (alpha = 0.05). The interaction between occupational therapy and light therapy will be explored (to understand whether the effect of light therapy \[if any\] on FACIT would change with occupational therapy and vice versa). The Functional Assessment of Chronic Illness Therapy (FACIT- fatigue scale) is a 13-item patient-reported measure of fatigue. Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so". To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. The higher the score, the better the Quality of Life (QoL).

  At baseline

• Functional Assessment of Cancer Therapy - (FACIT)

  The effects of light therapy and occupational therapy (OT) on FACIT will be evaluated by comparing light therapy to no-light therapy and comparing occupational therapy to no-occupational therapy. Analysis of variance test will be used for the factorial comparisons, with a two-sided statistical significance level (alpha = 0.05). The interaction between occupational therapy and light therapy will be explored (to understand whether the effect of light therapy \[if any\] on FACIT would change with occupational therapy and vice versa). The Functional Assessment of Chronic Illness Therapy (FACIT- fatigue scale) is a 13-item patient-reported measure of fatigue. Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so". To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. The higher the score, the better the Quality of Life (QoL).

  6 weeks after baseline

• Functional Assessment of Cancer Therapy - (FACIT)

  The effects of light therapy and occupational therapy (OT) on FACIT will be evaluated by comparing light therapy to no-light therapy and comparing occupational therapy to no-occupational therapy. Analysis of variance test will be used for the factorial comparisons, with a two-sided statistical significance level (alpha = 0.05). The interaction between occupational therapy and light therapy will be explored (to understand whether the effect of light therapy \[if any\] on FACIT would change with occupational therapy and vice versa). The Functional Assessment of Chronic Illness Therapy (FACIT- fatigue scale) is a 13-item patient-reported measure of fatigue. Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so". To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. The higher the score, the better the Quality of Life (QoL).

  3 months after baseline

Secondary Outcomes (5)

• Longitudinal change in FACIT-Fatigue scores

  Baseline

• Longitudinal change in FACIT-Fatigue scores

  6 weeks after baseline

• Longitudinal change in FACIT-Fatigue scores

  3 months after baseline

• Self-reported occupational performance - Baseline

  Baseline

• Self-reported occupational performance - session 6

  6 weeks after baseline

Study Arms (4)

Arm I (BWL)

EXPERIMENTAL

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.

Device: Bright White Light Therapy; Other: Questionnaire Administration

Arm II (OT)

EXPERIMENTAL

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

Behavioral: Occupational Therapy; Other: Questionnaire Administration

Arm III (OT, BWL)

EXPERIMENTAL

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.

Device: Bright White Light Therapy; Behavioral: Occupational Therapy; Other: Questionnaire Administration

Arm IV (Control)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Questionnaire Administration

Interventions

Bright White Light Therapy DEVICE

Undergo bright white therapy

Also known as: Bright Light Therapy, Bright White Light, BWL

Arm I (BWL); Arm III (OT, BWL)

Occupational Therapy BEHAVIORAL

Undergo occupational therapy

Also known as: OT

Arm II (OT); Arm III (OT, BWL)

Questionnaire Administration OTHER

Complete questionnaires

Arm I (BWL); Arm II (OT); Arm III (OT, BWL); Arm IV (Control)

Best Practice OTHER

Undergo routine treatment and usual follow up care

Also known as: standard of care, standard therapy

Arm IV (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Renal Cell; Prostatic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Ultraviolet Therapy; Occupational Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Kidney Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Phototherapy; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• William Dale

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 29, 2022
• Study Start: November 29, 2022
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): May 25, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)