Trial Summary
What is the purpose of this trial?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.
Is Occupational Therapy a promising treatment for genitourinary cancers?The information provided does not directly address the effectiveness of Occupational Therapy for genitourinary cancers. The articles focus on androgen deprivation therapy and its effects on prostate cancer, but do not mention Occupational Therapy. Therefore, we cannot determine if Occupational Therapy is a promising treatment for genitourinary cancers based on this information.1361013
What safety data exists for Light Therapy and Occupational Therapy in genitourinary cancers?The provided research does not directly address the safety data for Light Therapy and Occupational Therapy in genitourinary cancers. The studies focus on the effects of androgen deprivation therapy (ADT) and the role of exercise in managing its adverse effects, particularly in prostate cancer. There is no specific mention of safety data for Light Therapy or Occupational Therapy in the context of genitourinary cancers.237812
What data supports the idea that Light Therapy + Occupational Therapy for Genitourinary Cancers is an effective treatment?The available research shows that occupational therapy can improve the quality of life for patients with cancer, including those with metastatic prostate cancer. While specific data on Light Therapy combined with Occupational Therapy for genitourinary cancers is not provided, studies indicate that occupational therapy helps patients function better and live more independently. This suggests that combining it with Light Therapy could be beneficial, although more research is needed to confirm its effectiveness compared to other treatments.4591114
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, since participants must be on active treatment like chemotherapy or radiotherapy, it seems you can continue your current cancer treatments.
Eligibility Criteria
This trial is for adults over 18 with genitourinary cancers like prostate, kidney, and bladder cancer who are experiencing mild to moderate fatigue during treatment. They must speak English well enough to consent and have a life expectancy of at least six months. People with severe sleep disorders, psychological impairments, recent eye surgery or diseases affecting light processing in the eyes, sensitivity to light or seizures cannot participate.Inclusion Criteria
I am currently undergoing treatment such as chemotherapy, immunotherapy, or radiotherapy.
I have cancer in my urinary system and feel mildly to moderately tired.
Exclusion Criteria
I have a severe sleep disorder like narcolepsy.
I have used light therapy for fatigue or depression.
I do not have severe eye conditions that affect my vision.
I have been diagnosed with another cancer within the last 5 years.
I had eye surgery in the last 6 months and my eyes are still irritated.
Treatment Details
The study is testing whether combining bright white light therapy with occupational therapy can help reduce fatigue in patients undergoing treatment for genitourinary cancers. Light therapy is simple and low-cost while occupational therapy helps manage daily activities; together they might improve energy levels.
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (OT, BWL)Experimental Treatment3 Interventions
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.
Group II: Arm II (OT)Experimental Treatment2 Interventions
Patients undergo 6 occupational therapist-led sessions over 60 minutes each.
Group III: Arm I (BWL)Experimental Treatment2 Interventions
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.
Group IV: Arm IV (Control)Active Control2 Interventions
Patients undergo routine treatment and usual follow up care with their medical oncologist.
Occupational Therapy is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Occupational Therapy for:
- Rehabilitation
- Physical disabilities
- Mental health conditions
- Cancer-related fatigue
🇪🇺 Approved in European Union as Occupational Therapy for:
- Rehabilitation
- Physical disabilities
- Mental health conditions
- Cancer-related fatigue
🇨🇦 Approved in Canada as Occupational Therapy for:
- Rehabilitation
- Physical disabilities
- Mental health conditions
- Cancer-related fatigue
🇦🇺 Approved in Australia as Occupational Therapy for:
- Rehabilitation
- Physical disabilities
- Mental health conditions
- Cancer-related fatigue
Find a clinic near you
Research locations nearbySelect from list below to view details:
City of Hope Medical CenterDuarte, CA
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Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Optimizing outcomes and quality of life in the hormonal treatment of prostate cancer. [2006]We review the effectiveness of androgen-deprivation therapy (ADT) in the management of prostate cancer, and the effect that this treatment has on a patient's quality of life (QoL), based on discussions held at a European symposium on the management of prostate cancer. The overall QoL is reduced in asymptomatic men, and there are known decreases in cognitive function, self-esteem, libido and sexual function. Hot flashes are also a frequent problem. Prolonged ADT can lead to osteoporosis and subsequently fractures. Various effective methods exist to manage and minimize these side-effects; some are specific to the side-effect, whereas other more general methods include lifestyle changes, specific drugs and added hormonal manipulations. Intermittent ADT for patients taking luteinizing hormone-releasing hormone agonists offers a promising method to reduce adverse effects, and possibly increases the time to androgen independence. Initial studies indicate that prostate-specific antigen-based progression with intermittent ADT is similar to that seen with continuous ADT, but there is a reduction in side-effects, leading to an improvement in QoL.
Physical activity and genitourinary cancer survivorship. [2015]In this chapter we discuss common toxicities arising from genitourinary cancer treatments, in particular the adverse effects from androgen deprivation therapy (ADT) for prostate cancer given its well established detrimental effects on physical, physiological, and psychological function, and existing physical activity research in the postdiagnosis period including studies focusing on supportive care and some limited data on disease outcomes. Overall, consistent positive outcomes have been reported across studies showing that exercise is beneficial to reduce a number of treatment-related toxicities and improve symptoms. Additional studies are needed in genitourinary cancers other than prostate to establish specific physical activity requirements and implementation strategies.
Depression and androgen deprivation therapy for prostate cancer: a prospective controlled study. [2018]The main goal of this controlled study was to compare the presence of depressive symptoms and disorders in men receiving a combination of androgen deprivation therapy and radiation therapy (ADT-RTH) to men receiving RTH only.
Effects of occupational therapy on quality of life of patients with metastatic prostate cancer. A randomized controlled study. [2023]To evaluate the efficiency of occupational therapy relative to a home program in improving quality of life (QoL) among men who were treated for metastatic prostate cancer (MPC).
Occupational Therapy for Adults With Cancer: Why It Matters. [2022]Adults with cancer may be at risk for limitations in functional status and quality of life (QOL). Occupational therapy is a supportive service with the specific mission to help people functionally engage in life as safely and independently as possible with the primary goal of improving QOL. Unfortunately, for people with cancer, occupational therapy remains underused. The overall purpose of this review is to provide an understanding of what occupational therapy is and its relevance to patients with cancer, highlight the reasons to refer, and, last, provide general advice on how to access services.
Prospective assessment of the quality of life before, during and after image guided intensity modulated radiotherapy for prostate cancer. [2018]Radiotherapy (RT) in combination with androgen deprivation therapy (ADT) for prostate cancer (PCa) carries a risk of gastrointestinal (GI) and genitourinary toxicity, which might affect the quality of life (QoL). The purpose of this study was to assess the QoL in patients with PCa before, during and after radiotherapy (RT) and to compare the QoL 1 year after RT to a normal population.
The Role of Testosterone Therapy in the Setting of Prostate Cancer. [2018]The role of testosterone in the development of prostate cancer and the safety of testosterone therapy (TTh) after prostate cancer treatment, or in the setting of active surveillance, remains controversial. There are many concerns about using TTh in men, particularly those with a history of prostate cancer, ranging from a possible increased risk of cardiovascular disease to cancer progression or recurrence. With many prostate cancer patients living longer, and hypogonadism having significant morbidity, much care must go into the decision to treat. Here, we review the literature investigating the effects of testosterone on the prostate as well as the efficacy and safety of exogenous testosterone in men with a history of prostate cancer.
A Nomogram for Testosterone Recovery After Combined Androgen Deprivation and Radiation Therapy for Prostate Cancer. [2019]Testosterone recovery (TR) after androgen deprivation therapy (ADT) and radiation therapy (RT) is not well characterized. We studied TR in men who received RT and either short-term ADT (STADT) or long-term ADT (LTADT) and aimed to create a nomogram to predict TR.
Older Adults with Cancer: A Randomized Controlled Trial of Occupational and Physical Therapy. [2021]The impact of occupational therapy (OT) and physical therapy (PT) on functional outcomes in older adults with cancer is unknown.
Lower urinary tract symptoms in patients with advanced prostate cancer: What are the outcomes of androgen deprivation therapy? [2022]Androgen deprivation therapy (ADT) is accepted as the first-line treatment of advanced prostate cancer. This study sets out to determine the outcomes of ADT in reducing lower urinary tract symptoms (LUTS) in patients with advanced prostate cancer and also to determine the quality of life (QoL) of the patients.
Reasons for and outcome of occupational therapy consultation and treatment in the context of multidisciplinary cancer rehabilitation; a historical cohort study. [2021]The aim of this study was to investigate reasons why people consulted an occupational therapist following cancer treatment, and to examine the outcome of occupational therapy interventions, in the context of multidisciplinary rehabilitation.
The role of exercise in the management of adverse effects of androgen deprivation therapy for prostate cancer: a rapid review. [2021]Prostate cancer (PCa) is the most commonly diagnosed cancer in Australia, accounting for one quarter of all new cancer diagnoses for males. Androgen deprivation therapy (ADT) is the standard first-line therapy for metastatic PCa but is also used across much of the spectrum of disease. Unfortunately, debilitating adverse effects are a significant and largely unavoidable feature of ADT. A recent systematic review of adverse effects of ADT identified 19 sub-groups classified according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The potential for multiple simultaneous adverse effects, their associated management and the impact of adverse effects on cancer outcomes and quality of life are important considerations in the treatment and supportive care of men with PCa. Exercise is increasingly being recognized as an efficacious strategy in managing these adverse effects.
Combination of Radiation Therapy and Short-Term Androgen Blockade With Abiraterone Acetate Plus Prednisone for Men With High- and Intermediate-Risk Localized Prostate Cancer. [2021]Long-term androgen-deprivation therapy (ADT) is the standard of care in combination with radiation therapy (RT) in high-risk prostate cancer (PC), despite substantial toxicity from the resulting hypogonadism. We hypothesized that a combination of more potent but shorter-term androgen inhibition in men with intermediate- or high-risk localized PC would synergize with definitive RT to provide short-term testosterone recovery and improve disease control.
Occupational therapy intervention for cancer patients following hospital discharge: How and when should we intervene? A systematic review. [2021]Advances in cancer treatment over the last decade have led to increased survival rates. As a result, survivors are living longer with and beyond cancer, often with greater levels of morbidity. Occupational therapists, with their focus on remedial and compensatory strategies to improve function and participation, are well suited to assess and intervene with this population. Despite this, little research exists to demonstrate the efficacy of interventions and value of the occupational therapy role. This systematic review aimed to review how and when occupational therapists provide services for adult patients with cancer and identify where they add the most value.