NCT05519878

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Bladder Carcinoma
• Genitourinary System Neoplasm
• Kidney Carcinoma
• Prostate Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Undergo routine treatment and usual follow up care
DEVICE	Bright White Light Therapy	Undergo bright white therapy
BEHAVIORAL	Occupational Therapy	Undergo occupational therapy
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2022-11-29
• Primary completion: 2027-05-25
• Completion: 2027-05-25
• First posted: 2022-08-29
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study