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

Primary Purpose

Bladder Carcinoma, Genitourinary System Neoplasm, Kidney Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Bright White Light Therapy
Occupational Therapy
Questionnaire Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bladder Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Arm I (BWL)

Arm II (OT)

Arm III (OT, BWL)

Arm IV (Control)

Arm Description

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.

Patients undergo 6 occupational therapist-led sessions over 60 minutes each.

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.

Patients undergo routine treatment and usual follow up care with their medical oncologist.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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.
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.
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.
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).
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).

Full Information

First Posted
August 22, 2022
Last Updated
December 8, 2022
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05519878
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
August 11, 2026 (Anticipated)
Study Completion Date
August 11, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Carcinoma, Genitourinary System Neoplasm, Kidney Carcinoma, Prostate Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (BWL)
Arm Type
Experimental
Arm Description
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 Title
Arm II (OT)
Arm Type
Experimental
Arm Description
Patients undergo 6 occupational therapist-led sessions over 60 minutes each.
Arm Title
Arm III (OT, BWL)
Arm Type
Experimental
Arm Description
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 Title
Arm IV (Control)
Arm Type
Active Comparator
Arm Description
Patients undergo routine treatment and usual follow up care with their medical oncologist.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Undergo routine treatment and usual follow up care
Intervention Type
Device
Intervention Name(s)
Bright White Light Therapy
Other Intervention Name(s)
Bright Light Therapy, Bright White Light, BWL
Intervention Description
Undergo bright white therapy
Intervention Type
Behavioral
Intervention Name(s)
Occupational Therapy
Other Intervention Name(s)
OT
Intervention Description
Undergo occupational therapy
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaires
Primary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy - (FACIT)
Description
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).
Time Frame
At baseline
Title
Functional Assessment of Cancer Therapy - (FACIT)
Description
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).
Time Frame
6 weeks after baseline
Title
Functional Assessment of Cancer Therapy - (FACIT)
Description
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).
Time Frame
3 months after baseline
Secondary Outcome Measure Information:
Title
Longitudinal change in FACIT-Fatigue scores
Description
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.
Time Frame
Baseline
Title
Longitudinal change in FACIT-Fatigue scores
Description
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.
Time Frame
6 weeks after baseline
Title
Longitudinal change in FACIT-Fatigue scores
Description
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.
Time Frame
3 months after baseline
Title
Self-reported occupational performance - Baseline
Description
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).
Time Frame
Baseline
Title
Self-reported occupational performance - session 6
Description
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).
Time Frame
6 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Dale
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Dale
Phone
626-256-4673
Email
wdale@coh.org
First Name & Middle Initial & Last Name & Degree
William Dale

12. IPD Sharing Statement

Learn more about this trial

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

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