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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Best Practice
  Undergo routine treatment and usual follow up care
• Устройство Bright White Light Therapy
  Undergo bright white therapy
• Поведенческое Occupational Therapy
  Undergo occupational therapy
• Другое Questionnaire Administration
  Complete questionnaires

Первичные конечные точки

• Functional Assessment of Cancer Therapy - (FACIT) [Срок оценки: At baseline]
• Functional Assessment of Cancer Therapy - (FACIT) [Срок оценки: 6 weeks after baseline]
• Functional Assessment of Cancer Therapy - (FACIT) [Срок оценки: 3 months after baseline]

Вторичные конечные точки (5)

• Longitudinal change in FACIT-Fatigue scores [Срок оценки: Baseline]
• Longitudinal change in FACIT-Fatigue scores [Срок оценки: 6 weeks after baseline]
• Longitudinal change in FACIT-Fatigue scores [Срок оценки: 3 months after baseline]
• Self-reported occupational performance - Baseline [Срок оценки: Baseline]
• Self-reported occupational performance - session 6 [Срок оценки: 6 weeks after baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• City of Hope Medical Center — Duarte

Идентификаторы

NCT: NCT05519878 · 22235 · NCI-2022-05658 · 22235 · P30CA033572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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