Prostate Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

224

Study ID:

NCT05519878

Recruitment Status:

Not yet recruiting

Sponsor:

City of Hope Medical Center

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There is 1 Location for this study

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City of Hope Medical Center
Duarte California, 91010, United States More Info
William Dale
Contact
626-256-4673
[email protected]
William Dale
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

224

Study ID:

NCT05519878

Recruitment Status:

Not yet recruiting

Sponsor:


City of Hope Medical Center

How clear is this clinincal trial information?

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