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Spots Global Cancer Trial Database for Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers

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Trial Identification

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

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

Study ID: NCT05519878

Study Description

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.

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

City of Hope Medical Center, Duarte, California, United States

Contact Details

Name: William Dale

Affiliation: City of Hope Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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