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

Assessing Efficacy of a Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Carcinoma; Kidney Carcinoma; Prostate Carcinoma; Genitourinary System Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Device: Bright White Light Therapy; Behavioral: Occupational Therapy; Other: Best Practice

Detailed Description

PRIMARY OBJECTIVE:

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.

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Contact: William Dale; Phone Number: 626-256-4673; Email: wdale@coh.org
      • Principal Investigator: William Dale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Complete questionnaires; Device: Bright White Light Therapy; Undergo bright white therapy; Other Names: BWL; Bright Light Therapy; Bright White Light
Experimental: Arm II (OT); Patients undergo 6 occupational therapist-led sessions over 60 minutes each.	Other: Questionnaire Administration; Complete questionnaires; Behavioral: Occupational Therapy; Undergo occupational therapy; Other Names: OT
Experimental: 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.	Other: Questionnaire Administration; Complete questionnaires; Device: Bright White Light Therapy; Undergo bright white therapy; Other Names: BWL; Bright Light Therapy; Bright White Light; Behavioral: Occupational Therapy; Undergo occupational therapy; Other Names: OT
Active Comparator: Arm IV (Control); Patients undergo routine treatment and usual follow up care with their medical oncologist.	Other: Questionnaire Administration; Complete questionnaires; Other: Best Practice; Undergo routine treatment and usual follow up care; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longitudinal change in FACIT-Fatigue scores	Will evaluate whether the longitudinal change in FACIT-Fatigue scores, is significantly different between the intervention groups, including the control group. 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 QoL.	Baseline
Longitudinal change in FACIT-Fatigue scores	Will evaluate whether the longitudinal change in FACIT-Fatigue scores, is significantly different between the intervention groups, including the control group. 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 QoL.	6 weeks after baseline
Longitudinal change in FACIT-Fatigue scores	Will evaluate whether the longitudinal change in FACIT-Fatigue scores, is significantly different between the intervention groups, including the control group. 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 QoL.	3 months after baseline
Self-reported occupational performance - Baseline	Will determine if an OT-based intervention can improve self-reported occupational performance from preassessment to immediately after time point 2 (session 6) This outcome measure is Canadian Occupational Performance Measure (COPM). Its administration involves four steps: (a) the patient is asked to identify occupations that are difficult for him or her in self-care, productivity and leisure; (b) the importance of these problem occupations is rated on a scale of 1-10 in terms of importance (1 = least important, 10 = most important); (c) patients' perceptions of performance and satisfaction with their five most important problems are rated on two separate 10-point scales (performance 1 = not able to do it, 10 = able to do it extremely well; satisfaction 1 = not satisfied at all, 10 = extremely satisfied) and finally (d) at reassessment both the performance and satisfaction ratings are repeated (and the change between assessment and reassessment is evaluated).	Baseline
Self-reported occupational performance - session 6	Will determine if an OT-based intervention can improve self-reported occupational performance from preassessment to immediately after time point 2 (session 6) This outcome measure is Canadian Occupational Performance Measure (COPM). Its administration involves four steps: (a) the patient is asked to identify occupations that are difficult for him or her in self-care, productivity and leisure; (b) the importance of these problem occupations is rated on a scale of 1-10 in terms of importance (1 = least important, 10 = most important); (c) patients' perceptions of performance and satisfaction with their five most important problems are rated on two separate 10-point scales (performance 1 = not able to do it, 10 = able to do it extremely well; satisfaction 1 = not satisfied at all, 10 = extremely satisfied) and finally (d) at reassessment both the performance and satisfaction ratings are repeated (and the change between assessment and reassessment is evaluated).	6 weeks after baseline

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: William Dale, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): May 25, 2027

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Urinary Bladder Diseases; Prostatic Neoplasms; Carcinoma, Renal Cell; Urinary Bladder Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Quality of Health Care; Quality Indicators, Health Care; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Guidelines as Topic; Quality Assurance, Health Care; Phototherapy; Standard of Care; Practice Guidelines as Topic; Occupational Therapy; Ultraviolet Therapy
• Other Study ID Numbers: 22235 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2022-05658 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes