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

Study Overview
=================
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.

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

Conditions
-----------------
Bladder Carcinoma, Genitourinary System Neoplasm, Kidney Carcinoma, Prostate Carcinoma

Intervention / Treatment
-----------------
* Other: Best Practice
* Device: Bright White Light Therapy
* Behavioral: Occupational Therapy
* Other: Questionnaire Administration


Participation 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (BWL)<br>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 Therapy<br>* Undergo bright white therapy<br>* Other names: BWL;Other: Questionnaire Administration<br>* Complete questionnaires<br>|
| Experimental: Arm II (OT)<br>Patients undergo 6 occupational therapist-led sessions over 60 minutes each. | Behavioral: Occupational Therapy<br>* Undergo occupational therapy<br>* Other names: OT;Other: Questionnaire Administration<br>* Complete questionnaires<br>|
| Experimental: Arm III (OT, BWL)<br>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 Therapy<br>* Undergo bright white therapy<br>* Other names: BWL;Behavioral: Occupational Therapy<br>* Undergo occupational therapy<br>* Other names: OT;Other: Questionnaire Administration<br>* Complete questionnaires<br>|
| Active Comparator: Arm IV (Control)<br>Patients undergo routine treatment and usual follow up care with their medical oncologist. | Other: Best Practice<br>* Undergo routine treatment and usual follow up care<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy - (FACIT) | The effects of light therapy and occupational therapy (OT) on FACIT will be evaluated by comparing light therapy to no-light therapy and comparing occupational therapy to no-occupational therapy. Analysis of variance test will be used for the factorial comparisons, with a two-sided statistical significance level (alpha = 0.05). The interaction between occupational therapy and light therapy will be explored (to understand whether the effect of light therapy [if any] on FACIT would change with occupational therapy and vice versa). The Functional Assessment of Chronic Illness Therapy (FACIT- fatigue scale) is a 13-item patient-reported measure of fatigue. Items are scored on a 0 - 4 response scale with anchors ranging from Not at all to Very much so. To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. The higher the score, the better the Quality of Life (QoL). | At baseline | 
| Functional Assessment of Cancer Therapy - (FACIT) | The effects of light therapy and occupational therapy (OT) on FACIT will be evaluated by comparing light therapy to no-light therapy and comparing occupational therapy to no-occupational therapy. Analysis of variance test will be used for the factorial comparisons, with a two-sided statistical significance level (alpha = 0.05). The interaction between occupational therapy and light therapy will be explored (to understand whether the effect of light therapy [if any] on FACIT would change with occupational therapy and vice versa). The Functional Assessment of Chronic Illness Therapy (FACIT- fatigue scale) is a 13-item patient-reported measure of fatigue. Items are scored on a 0 - 4 response scale with anchors ranging from Not at all to Very much so. To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. The higher the score, the better the Quality of Life (QoL). | 6 weeks after baseline | 
| Functional Assessment of Cancer Therapy - (FACIT) | The effects of light therapy and occupational therapy (OT) on FACIT will be evaluated by comparing light therapy to no-light therapy and comparing occupational therapy to no-occupational therapy. Analysis of variance test will be used for the factorial comparisons, with a two-sided statistical significance level (alpha = 0.05). The interaction between occupational therapy and light therapy will be explored (to understand whether the effect of light therapy [if any] on FACIT would change with occupational therapy and vice versa). The Functional Assessment of Chronic Illness Therapy (FACIT- fatigue scale) is a 13-item patient-reported measure of fatigue. Items are scored on a 0 - 4 response scale with anchors ranging from Not at all to Very much so. To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. The higher the score, the better the Quality of Life (QoL). | 3 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal change in FACIT-Fatigue scores | Will evaluate whether the longitudinal change in FACIT-Fatigue scores, is significantly different between the intervention groups, including the control group. The Functional Assessment of Chronic Illness Therapy (FACIT- fatigue scale) is a 13-item patient-reported measure of fatigue. Items are scored on a 0 - 4 response scale with anchors ranging from Not at all to Very much so. To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. The higher the score, the better the QoL. | Baseline | 
| Longitudinal change in FACIT-Fatigue scores | Will evaluate whether the longitudinal change in FACIT-Fatigue scores, is significantly different between the intervention groups, including the control group. The Functional Assessment of Chronic Illness Therapy (FACIT- fatigue scale) is a 13-item patient-reported measure of fatigue. Items are scored on a 0 - 4 response scale with anchors ranging from Not at all to Very much so. To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. The higher the score, the better the QoL. | 6 weeks after baseline | 
| Longitudinal change in FACIT-Fatigue scores | Will evaluate whether the longitudinal change in FACIT-Fatigue scores, is significantly different between the intervention groups, including the control group. The Functional Assessment of Chronic Illness Therapy (FACIT- fatigue scale) is a 13-item patient-reported measure of fatigue. Items are scored on a 0 - 4 response scale with anchors ranging from Not at all to Very much so. To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. The higher the score, the better the QoL. | 3 months after baseline | 
| Self-reported occupational performance - Baseline | Will determine if an OT-based intervention can improve self-reported occupational performance from preassessment to immediately after time point 2 (session 6) This outcome measure is Canadian Occupational Performance Measure (COPM). Its administration involves four steps: (a) the patient is asked to identify occupations that are difficult for him or her in self-care, productivity and leisure; (b) the importance of these problem occupations is rated on a scale of 1-10 in terms of importance (1 = least important, 10 = most important); (c) patients' perceptions of performance and satisfaction with their five most important problems are rated on two separate 10-point scales (performance 1 = not able to do it, 10 = able to do it extremely well; satisfaction 1 = not satisfied at all, 10 = extremely satisfied) and finally (d) at reassessment both the performance and satisfaction ratings are repeated (and the change between assessment and reassessment is evaluated). | Baseline | 
| Self-reported occupational performance - session 6 | Will determine if an OT-based intervention can improve self-reported occupational performance from preassessment to immediately after time point 2 (session 6) This outcome measure is Canadian Occupational Performance Measure (COPM). Its administration involves four steps: (a) the patient is asked to identify occupations that are difficult for him or her in self-care, productivity and leisure; (b) the importance of these problem occupations is rated on a scale of 1-10 in terms of importance (1 = least important, 10 = most important); (c) patients' perceptions of performance and satisfaction with their five most important problems are rated on two separate 10-point scales (performance 1 = not able to do it, 10 = able to do it extremely well; satisfaction 1 = not satisfied at all, 10 = extremely satisfied) and finally (d) at reassessment both the performance and satisfaction ratings are repeated (and the change between assessment and reassessment is evaluated). | 6 weeks after baseline |