Treating Cancer-Related Fatigue Through Systematic Light Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 4
- 主要终点
- FACIT-Fatigue Scale
研究概览
简要总结
Cancer related fatigue (CRF) is the most common cancer side effect and can severely interfere with activities of daily living long after completion of medical treatment. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non-pharmacological interventions for CRF have also been studied but are costly to implement and involve significant patient burden. This study investigates a novel low-cost/ low-burden intervention: systematic light exposure to treat CRF. Two hundred survivors of multiple myeloma and Diffuse Large B-cell Lymphoma between 1 month and 5 years post-autologous stem cell transplant (ASCT) will be recruited from three medical centers. The light will be administered by a small, personal light glasses daily for 4 weeks. Outcomes will be assessed at five separate time points, including baseline and follow-up. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI, 2013).The proposed study will: 1) be the first large multisite study with a carefully delineated comparison condition to investigate the effects of light on CRF among ASCT survivors; 2) focus on a distinct, homogenous patient population; 3) include only survivors who experience clinical levels of CRF; and 4) address possible psychological and biological mechanisms. This study will have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively reduces CRF.
详细描述
The proposed multi-site randomized controlled trial (RCT) will investigate a novel intervention, systematic light exposure (sLE), to treat cancer-related fatigue (CRF) among Multiple Myeloma (MM) and Diffuse Large B-Cell Lymphoma (DLBCL) following autologous stem cell transplantation (ASCT). Cancer related fatigue (CRF) is persistent exhaustion related to cancer and/or its treatment. CRF is the most common cancer side effect and can severely interfere with activities of daily living long after completion of all medical treatment. Pharmacologic agents to treat CRF have been studied but there is insufficient evidence to recommend their use. Non-pharmacological interventions for CRF (including yoga, cognitive behavior therapy, hypnosis, and exercise) have also been studied; however, such interventions are costly to implement and involve significant patient burden. sLE is a low-cost, low- burden intervention that we have found to have beneficial effects for patients post-ASCT. The investigators initial randomized trial for CRF found that certain light exposure was associated with clinically significant reductions in fatigue (effect size d=0.98) More relevant to the proposed research is the preliminary investigation with sLE to treat CRF in MM and DLBCL which found that patients receiving certain sLE reported significantly less fatigue ( p=0.052). The proposed RCT will test the efficacy of sLE on CRF. It will also assess the effect of sLE on sleep, depressive symptoms, and both activity and cortisol circadian rhythms as these related processes have been hypothesized as possible mechanisms of
sLE's effects on CRF. Two hundred survivors of multiple myeloma and Diffuse Large B-cell Lymphoma between 1 month and 5 years post-autologous stem cell transplant (ASCT) will be recruited from two medical centers.
The light will be administered by light glasses for 4 weeks. Outcomes will be assessed at five separate time points including baseline and follow-ups.
The researchers' preliminary research has established the feasibility of this proposal. Moreover, in the preliminary research, 75% of participants completed the preliminary trial and data from the light box compliance meters showed that participants used the light boxes 80% of the days that treatment was scheduled. A large sample of fatigued MM and DLBCL ASCT survivors has been identified. The study will specifically address recommendations made for interventions for CRF from the NCI Clinical Trials Planning meeting (JNCI, 2013). It will: 1) be the first large multisite study with a carefully delineated comparison condition to investigate the effects of light on CRF among cancer survivors treated with ASCT; 2) focus on a distinct, homogenous patient population (MM and DLBCL ASCT survivors); 3) include only survivors who experience clinical levels of CRF; and 4) address possible mechanisms. This RCT will have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention reduces CRF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In remission (partial to complete remission) verified by medical records
- •With a history of ASCT as treatment for hematological malignancies such as MM, DLBCL, and related diseases and who are between one month and five years post-transplant
- •With a score equal to or less than 33 on the FACIT-Fatigue scale (see below)
- •Who are currently over age 18 and were at least age 16 at the time of ASCT
排除标准
- •COVID diagnoses (active COVID-19) at the time of recruitment
- •Under age 18
- •Pregnancy
- •Confounding underlying medical illnesses which may cause fatigue (e.g., severe Anemia not controlled by medication, per self-report corroborated by medical chart review (e.g., Hb<10gm/dl) )
- •Severe sleep disorders (e.g. Narcolepsy)
- •Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, glaucoma that causes visual impairment, macular degeneration, blindness, pupil dilation problems or retina damage)
- •Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months)
- •Currently employed in night shift work
- •Previous use of light therapy to alleviate fatigue or depressive symptoms
- •Self-reported history of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
- •Severe Psychiatric disorders assessed by the Psychoticism-Paranoia Screener
- •Secondary cancer diagnosis (prior or current) within the past 5 years
- •Plans to travel across meridians during the study
- •To decrease sample heterogeneity (consistent with JNCI, 2013 recommendations), allogeneic-HSCT survivors will not be eligible for the study.
结局指标
主要结局
FACIT-Fatigue Scale
时间窗: 4 Years
Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale. 13-item scale, each item 0=not at all to 4=very much, with higher score indicating more fatigue
次要结局
- General Anxiety Disorder 7-item questionnaire (GAD-7)(4 years)
- Self Compassion Scale -SCS(4 years)
- Brief Symptom Inventory-18 (BSI-18)(4 years)
- The Anxiety Sensitivity Index-3 - (ASI-3)(4 years)
- Center for Epidemiologic Studies Depression Scale (CES-D)(4 years)
- Multidimensional Fatigue Symptom Inventory - Short Form(4 years)
- The Beck Depression Inventory II (BDI-II)(4 years)
- Connor-Davidson Resilience Scale (CD-RISC-10)(4 years)
- MEQ- SA - Morningness Eveningness Questionnaire(4 years)
- Correlation between sLE (or "Experimental Light") and circadian rhythms(4 years)
- Pittsburgh Sleep Quality Index (PSQI)(4 years)
- Correlation between sLE (or "Experimental Light") and depressive changes(4 years)
- Positive and Negative Affect Schedule (PANAS)(4 years)
- Patient Assessment of Own Functioning - PAOFI(4 years)
- Rest/activity cycles(4 years)
- Correlation between Experimental Light compared with Comparison Light and cortisol circadian rhythm(4 years)
- Impact of Event Scale - Revised (IES-R)(4 years)
- Posttraumatic Growth Inventory - (PTGI) Short Form(4 years)
- The Social Constraints Scale (SCS)(4 years)
- C/E- Credibility/Expectancy Questionnaire(4 years)
- Perceive Stress Scale (PSS)(4 years)
- Social Provision Scale(4 years)
研究者
William H. Redd
Professor
Icahn School of Medicine at Mount Sinai