Clinical trial NCT05519878: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Carcinoma
Genitourinary System Neoplasm
Kidney Carcinoma
Prostate Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-08-29
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - (FACIT)
timeFrame: At baseline
measure: Functional Assessment of Cancer Therapy - (FACIT)
timeFrame: 6 weeks after baseline
measure: Functional Assessment of Cancer Therapy - (FACIT)
timeFrame: 3 months after baseline
Secondary outcomes:
measure: Longitudinal change in FACIT-Fatigue scores
timeFrame: Baseline
measure: Longitudinal change in FACIT-Fatigue scores
timeFrame: 6 weeks after baseline
measure: Longitudinal change in FACIT-Fatigue scores
timeFrame: 3 months after baseline
measure: Self-reported occupational performance - Baseline
timeFrame: Baseline
measure: Self-reported occupational performance - session 6
timeFrame: 6 weeks after baseline
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: William Dale
role: PRINCIPAL_INVESTIGATOR
References: