Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers
Status
RECRUITING
Phase
NA
Age
≥ 18 Years
Enrollments
224Conditions
Bladder Carcinoma, Genitourinary System Neoplasm, Kidney Carcinoma, Prostate CarcinomaSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- William Dale
- 626-256-4673
- [email protected]
Principal Investigator
- William Dale
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 Plan
Arm I (BWL)
EXPERIMENTAL
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.
DEVICE:
Bright White Light TherapyDescription:
Undergo bright white therapyOTHER:
Questionnaire AdministrationDescription:
Complete questionnaires
Arm II (OT)
EXPERIMENTAL
Patients undergo 6 occupational therapist-led sessions over 60 minutes each.
BEHAVIORAL:
Occupational TherapyDescription:
Undergo occupational therapyOTHER:
Questionnaire AdministrationDescription:
Complete questionnaires
Arm III (OT, BWL)
EXPERIMENTAL
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.
DEVICE:
Bright White Light TherapyDescription:
Undergo bright white therapyBEHAVIORAL:
Occupational TherapyDescription:
Undergo occupational therapyOTHER:
Questionnaire AdministrationDescription:
Complete questionnaires
Arm IV (Control)
ACTIVE_COMPARATOR
Patients undergo routine treatment and usual follow up care with their medical oncologist.
OTHER:
Best PracticeDescription:
Undergo routine treatment and usual follow up careOTHER:
Questionnaire AdministrationDescription:
Complete questionnaires
Outcome Measures
Primary Outcome Measures
Functional Assessment of Cancer Therapy - (FACIT)
Functional Assessment of Cancer Therapy - (FACIT)
Functional Assessment of Cancer Therapy - (FACIT)
Secondary Outcome Measures
Longitudinal change in FACIT-Fatigue scores
Longitudinal change in FACIT-Fatigue scores
Longitudinal change in FACIT-Fatigue scores
Self-reported occupational performance - Baseline
Self-reported occupational performance - session 6
Timeline
Last Updated
December 18, 2023Start Date
August 29, 2022Today
February 5, 2025Completion Date ( Estimated )
May 25, 2027
Sponsors of this trial
Lead Sponsor
City of Hope Medical CenterCollaborating Sponsors
National Cancer Institute (NCI)
RECRUITING 
21 - 64 Years