Assessing Efficacy of a Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Functional Assessment of Cancer Therapy - (FACIT)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Functional Assessment of Cancer Therapy - (FACIT)
时间窗: 3 months after baseline
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).
次要结局
- Longitudinal change in FACIT-Fatigue scores(3 months after baseline)
- Self-reported occupational performance - Baseline(Baseline)
- Self-reported occupational performance - session 6(6 weeks after baseline)