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

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

NCT ID: NCT05519878

Condition: Bladder Carcinoma
Genitourinary System Neoplasm
Kidney Carcinoma
Prostate Carcinoma

Conditions: Official terms:
Carcinoma
Urinary Bladder Neoplasms
Urogenital Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Factorial Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Best Practice
Description: Undergo routine treatment and usual follow up care
Arm group label: Arm IV (Control)

Other name: standard of care

Other name: standard therapy

Intervention type: Device
Intervention name: Bright White Light Therapy
Description: Undergo bright white therapy
Arm group label: Arm I (BWL)
Arm group label: Arm III (OT, BWL)

Other name: Bright Light Therapy

Other name: Bright White Light

Other name: BWL

Intervention type: Behavioral
Intervention name: Occupational Therapy
Description: Undergo occupational therapy
Arm group label: Arm II (OT)
Arm group label: Arm III (OT, BWL)

Other name: OT

Intervention type: Other
Intervention name: Questionnaire Administration
Description: Complete questionnaires
Arm group label: Arm I (BWL)
Arm group label: Arm II (OT)
Arm group label: Arm III (OT, BWL)
Arm group label: Arm IV (Control)

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: City of Hope Medical Center

Address:
City: Duarte
Zip: 91010
Country: United States

Status: Recruiting

Contact:
Last name: William Dale

Phone: 626-256-4673
Email: wdale@coh.org

Investigator:
Last name: William Dale
Email: Principal Investigator

Start date: November 29, 2022

Completion date: May 25, 2027

Lead sponsor:
Agency: City of Hope Medical Center
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: City of Hope Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05519878