Light Therapy + Occupational Therapy for Genitourinary Cancers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Severe sleep disorders, Eye diseases, Severe psychological impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 3 months

224 Participants Needed

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.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves light and occupational therapy, it seems likely that you can continue your existing treatments, especially since participants must be on active cancer treatment.

What data supports the effectiveness of the treatment Light Therapy + Occupational Therapy for Genitourinary Cancers?

Research shows that occupational therapy can improve the quality of life for cancer patients by helping them engage in daily activities more independently. This suggests that combining occupational therapy with light therapy might offer benefits for patients with genitourinary cancers. ^{1 2 3 4 5}

How does the treatment of light therapy combined with occupational therapy for genitourinary cancers differ from other treatments?

This treatment is unique because it combines light therapy, which uses specific wavelengths of light to potentially improve mood and energy, with occupational therapy, which helps patients regain skills and improve their quality of life. Unlike standard drug treatments like androgen deprivation therapy (ADT) for prostate cancer, which can have significant side effects, this approach focuses on enhancing overall well-being and daily functioning. ^{6 7 8 9 10}

Research Team

William Dale

Principal Investigator

City of Hope Medical Center

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

Sufficiently fluent in English

I am willing and able to agree to participate on my own.

I am currently undergoing treatment such as chemotherapy, immunotherapy, or radiotherapy.

Exclusion Criteria

Severe psychological impairment (e.g., bipolar disorder or manic episodes)

I have a severe sleep disorder like narcolepsy.

I have used light therapy for fatigue or depression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive light therapy and/or occupational therapy interventions for 3 months

3 months

6 follow-up sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Bright White Light Therapy
• Occupational Therapy

Trial Overview 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.

Participant Groups

Group I: Arm III (OT, BWL) Experimental Treatment 3 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 Treatment 2 Interventions

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

Group III: Arm I (BWL) Experimental Treatment 2 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 Control 2 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 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

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study involving 63 older adults with cancer, occupational therapy (OT) and physical therapy (PT) showed a significant improvement in activity expectations and self-efficacy compared to usual care, although both groups experienced a decline in overall functional status.

Despite the positive effects of OT/PT on certain outcomes, challenges such as recruitment difficulties and logistical barriers hindered the implementation of the intervention, highlighting the need for improved access to these services for older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Adults with Cancer: A Randomized Controlled Trial of Occupational and Physical Therapy. Pergolotti, M., Deal, AM., Williams, GR., et al.[2021]

In a study of 181 cancer patients, the main reasons for seeking occupational therapy were related to improving 'Activities and Participation' in their daily lives after treatment.

Patients showed significant improvements in both performance and satisfaction scores on the Canadian Occupational Performance Measurement (COPM) after occupational therapy, indicating its positive impact on everyday functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reasons for and outcome of occupational therapy consultation and treatment in the context of multidisciplinary cancer rehabilitation; a historical cohort study. Rijpkema, C., Duijts, SFA., Stuiver, MM.[2021]

A 12-week occupational therapy intervention that included cognitive behavioral therapy significantly improved the quality of life (QoL) for 55 men treated for metastatic prostate cancer compared to a home program.

The improvements in QoL were linked to better occupational performance, as measured by the Canadian Occupational Performance Measure, indicating that targeted therapy can enhance daily living activities for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of occupational therapy on quality of life of patients with metastatic prostate cancer. A randomized controlled study. Huri, M., Huri, E., Kayihan, H., et al.[2023]

Occupational therapy interventions for adult cancer patients, although varied and based on small studies, showed positive outcomes when they were person-centered, individualized, and included regular monitoring, highlighting the importance of flexibility in care.

The review suggests that tailored programs that adapt to the patient's changing condition can effectively improve outcomes for cancer survivors, emphasizing the need for occupational therapists to collaborate with multidisciplinary teams and carefully select appropriate outcome measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational therapy intervention for cancer patients following hospital discharge: How and when should we intervene? A systematic review. Taylor, S., Keesing, S., Wallis, A., et al.[2021]

Occupational therapy can significantly improve the functional status and quality of life for adults with cancer, helping them engage in daily activities safely and independently.

Despite its benefits, occupational therapy is often underutilized by cancer patients, highlighting the need for increased awareness and referrals to these supportive services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational Therapy for Adults With Cancer: Why It Matters. Pergolotti, M., Williams, GR., Campbell, C., et al.[2022]

Androgen-deprivation therapy (ADT) for prostate cancer can significantly reduce quality of life (QoL) in patients, leading to issues like decreased cognitive function, self-esteem, libido, and increased risk of osteoporosis and fractures.

Intermittent ADT may be a promising alternative, as it shows similar effectiveness in managing prostate cancer while reducing side effects and improving QoL compared to continuous ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing outcomes and quality of life in the hormonal treatment of prostate cancer. Mottet, N., Prayer-Galetti, T., Hammerer, P., et al.[2006]

In a study of 60 men with nonmetastatic prostate cancer, those receiving androgen deprivation therapy (ADT) combined with radiation therapy (RTH) did not show significant increases in depressive symptoms compared to those receiving RTH alone, suggesting that ADT may not be a major risk factor for depression.

While there were fluctuations in depressive symptoms during the study, including decreases after stopping ADT, the overall effect sizes were small, indicating that ADT's impact on mental health may be minimal for patients already facing other treatment challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression and androgen deprivation therapy for prostate cancer: a prospective controlled study. Hervouet, S., Savard, J., Ivers, H., et al.[2018]

Androgen deprivation therapy (ADT) significantly improves lower urinary tract symptoms (LUTS) and quality of life (QoL) in patients with advanced prostate cancer, as shown by a study of 65 patients over 12 months, with notable reductions in mean IPSS scores and improvements in urodynamic parameters.

Despite the overall benefits of ADT, a subset of patients (approximately 12.3%) continued to experience persistent LUTS and required catheterization, indicating that not all patients respond equally to this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower urinary tract symptoms in patients with advanced prostate cancer: What are the outcomes of androgen deprivation therapy? Akpayak, IC., Shuaibu, SI., Ofoha, CG., et al.[2022]

In a study of 37 men with intermediate- or high-risk localized prostate cancer, a combination of 6 months of androgen-deprivation therapy (ADT) with abiraterone acetate and radiation therapy resulted in a 55% rate of undetectable prostate-specific antigen (PSA) levels at 12 months, indicating effective disease control.

The treatment was associated with manageable toxicity, primarily grade 3 hypertension in 32% of patients, and 81% of participants experienced testosterone recovery within a median time of 9.2 months, suggesting a favorable impact on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of Radiation Therapy and Short-Term Androgen Blockade With Abiraterone Acetate Plus Prednisone for Men With High- and Intermediate-Risk Localized Prostate Cancer. Koontz, BF., Hoffman, KE., Halabi, S., et al.[2021]

One year after radiotherapy, prostate cancer patients reported less pain and fewer physical limitations compared to their baseline measurements, indicating some improvement in quality of life (QoL).

Despite these improvements, patients still experienced worse mental health and vitality compared to a normal population, highlighting the need for supportive care during and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective assessment of the quality of life before, during and after image guided intensity modulated radiotherapy for prostate cancer. Sveistrup, J., Mortensen, OS., Bjørner, JB., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Older Adults with Cancer: A Randomized Controlled Trial of Occupational and Physical Therapy. [2021]

2. Australia pubmed.ncbi.nlm.nih.gov

Reasons for and outcome of occupational therapy consultation and treatment in the context of multidisciplinary cancer rehabilitation; a historical cohort study. [2021]

3. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Effects of occupational therapy on quality of life of patients with metastatic prostate cancer. A randomized controlled study. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Occupational therapy intervention for cancer patients following hospital discharge: How and when should we intervene? A systematic review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Occupational Therapy for Adults With Cancer: Why It Matters. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Optimizing outcomes and quality of life in the hormonal treatment of prostate cancer. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Depression and androgen deprivation therapy for prostate cancer: a prospective controlled study. [2018]

8. Nigeria pubmed.ncbi.nlm.nih.gov

Lower urinary tract symptoms in patients with advanced prostate cancer: What are the outcomes of androgen deprivation therapy? [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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]

10. England pubmed.ncbi.nlm.nih.gov

Prospective assessment of the quality of life before, during and after image guided intensity modulated radiotherapy for prostate cancer. [2018]