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Bladder CarcinomaNCT05519878

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

A study testing Best Practice, Bright White Light Therapy and Occupational Therapy in people with Bladder Carcinoma and Genitourinary System Neoplasm, run by City of Hope Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Best Practice, Bright White Light Therapy and Occupational Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
1 siteUnited States
Study dates
11 Jan 2023to 29 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • City of Hope Medical Center

    Duarte, California, 91010

    William Dale, 626-256-4673, wdale@coh.org

    William Dale

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate patient's fatigue at post-intervention (3 months from baseline).

SECONDARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Best Practice, Bright White Light Therapy, Occupational Therapy, Questionnaire Administration
Medical subject headings
Urinary Bladder Neoplasms, Carcinoma, Renal Cell, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Undergo routine treatment and usual follow up care

  • Bright White Light TherapyDevice

    Also called Bright Light Therapy, Bright White Light, BWL

    Undergo bright white therapy

  • Occupational TherapyBehavioural

    Also called OT

    Undergo occupational therapy

  • Questionnaire AdministrationOther

    Complete questionnaires

Study groups in NCT05519878
Study groupRoleWhat they receive
Arm I (BWL)ExperimentalPatients 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.
Receives: Device: Bright White Light Therapy; Other: Questionnaire Administration
Arm II (OT)ExperimentalPatients undergo 6 occupational therapist-led sessions over 60 minutes each.
Receives: Behavioral: Occupational Therapy; Other: Questionnaire Administration
Arm III (OT, BWL)ExperimentalPatients 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.
Receives: Device: Bright White Light Therapy; Behavioral: Occupational Therapy; Other: Questionnaire Administration
Arm IV (Control)Active comparatorPatients undergo routine treatment and usual follow up care with their medical oncologist.
Receives: Other: Best Practice; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: At baseline

  2. 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).

    Measured: 6 weeks after baseline

  3. 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).

    Measured: 3 months after baseline

Secondary outcomes (5)
  1. 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.

    Measured: Baseline

  2. 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.

    Measured: 6 weeks after baseline

  3. 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.

    Measured: 3 months after baseline

  4. 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).

    Measured: Baseline

  5. 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).

    Measured: 6 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2022
  2. Study start11 Jan 2023
  3. Primary completion29 May 2028 (estimated)
  4. Study completion29 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05519878
Sponsor's protocol ID
22235
Other IDs
NCI-2022-05658, 22235, P30CA033572
Status last verified
Oct 2026
First submitted
22 Aug 2022
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice, Bright White Light Therapy and Occupational Therapy in people with Bladder Carcinoma and Genitourinary System Neoplasm, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Assessment of Cancer Therapy - (FACIT) (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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