Feasibility of Adjunctive BLT for Amelioration of Fatigue in Chinese Cancer Patients Admitted to a Palliative Care Unit
NCT ID: NCT04525924
Last Updated: 2020-09-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
42 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-08-01
Study Completion Date
2020-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Fatigue is the most common symptom in palliative care patients who have advanced cancer. Fatigue is also one of the most underreported hence under-treated symptoms. Patients may perceive it as a condition to be endured, whereas healthcare workers find it very challenging to assess and treat due to its subjective nature and multi-dimensional causes.
However, evidence-based practice to tackle this distressing problem is still inadequate, and that a one-size fit all approach is unrealistic. Various pharmacological options have been examined, but due to limited evidence, no specific drug could be recommended.
Latest development in management of fatigue includes non-pharmacological approach. Bright Light Treatment (BLT) has also evolved as a favourable treatment for cancer-related fatigue. BLT is the prescription of artificial bright light over a designated period of time. Recent clinical evidence showed that BLT reduced symptom of fatigue in patients undergoing active chemotherapy and cancer survivours.
There is however no data on bright light therapy used in in-patient palliative care settings.
A single group, prospective interventional study will be conducted in in-patient palliative care unit of Shatin Hospital (N = 42). The aim is to assess the feasibility and impact of BLT as an in-patient intervention in a cohort of local Chinese palliative care in-patients diagnosed with incurable cancer with documented symptom of fatigue, and to ascertain the changes of fatigue, mood, sleep and quality of life after 1-week exposure of BLT.
However, evidence-based practice to tackle this distressing problem is still inadequate, and that a one-size fit all approach is unrealistic. Various pharmacological options have been examined, but due to limited evidence, no specific drug could be recommended.
Latest development in management of fatigue includes non-pharmacological approach. Bright Light Treatment (BLT) has also evolved as a favourable treatment for cancer-related fatigue. BLT is the prescription of artificial bright light over a designated period of time. Recent clinical evidence showed that BLT reduced symptom of fatigue in patients undergoing active chemotherapy and cancer survivours.
There is however no data on bright light therapy used in in-patient palliative care settings.
A single group, prospective interventional study will be conducted in in-patient palliative care unit of Shatin Hospital (N = 42). The aim is to assess the feasibility and impact of BLT as an in-patient intervention in a cohort of local Chinese palliative care in-patients diagnosed with incurable cancer with documented symptom of fatigue, and to ascertain the changes of fatigue, mood, sleep and quality of life after 1-week exposure of BLT.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
To Decrease Fatigue With Light Therapy
NCT03242902
Hodgkin Lymphoma
Diffuse Large B Cell Lymphoma
COMPLETED
PHASE3
Prognosis of Patient Evaluated for Palliative Radiotherapy
NCT03797755
Cancer
Radiotherapy
UNKNOWN
Study of Palliative Radiotherapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases
NCT02511522
Hepatocellular Carcinoma
Liver Metastases
COMPLETED
NA
Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT
NCT02456246
Non Small Cell Lung Cancer (NSCLC)
COMPLETED
NA
Acupuncture in Cancer Patients Undergoing Radiotherapy Treatment
NCT03433118
Cancer
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Fatigue is the most common symptom in palliative care patients who have advanced cancer, ranging from 59% to 77% depends on the assessment method (1). There is limited local data on the prevalence of fatigue in cancer patients. A cross-sectional study by Dr KY Lam in 2009 (unpublished data) found 53% of 55 patients receiving palliative care suffered from severe fatigue. A cross-sectional symptom screening of all the patients in the palliative care ward in Shatin Hospital showed 22 out of 55 (40%) patients reported fatigue (unpublished data).
The fatigue experienced by cancer patients is multi-dimensional. The feeling may be a physical sensation (weakness, tiredness, exhaustion, unable to perform tasks), an affective sensation (low mood, lack of motivation), or a cognitive sensation (lack of concentration, difficulty thinking clearly). This phenomenon is also subject to cultural interpretation therefore there is a need to understand each subject's perception and experience of fatigue within his or her own cultural context (2, 3).
Fatigue is also one of the most under-reported hence under-treated symptoms. Patients may perceive it as a condition to be endured, whereas healthcare workers find it very challenging to assess and treat due to its subjective nature and multidimensional causes. The impairment in self-care capabilities and daily functioning lead to negative effects on desire to continue treatment thus affecting the functional recovery even in patients with a more stable disease status (3-5). The quality of life (QOL) of patients, which is our focus in palliative care service, is heavily reduced (6).
However, evidence-based practice to tackle this distressing problem is still inadequate, and that a one-size fit all approach is unrealistic (7). Various pharmacological options have been examined, but due to limited evidence, no specific drug could be recommended for the treatment of fatigue in palliative care patients in the latest Cochrane review in 2015 (8).
Latest development in management of fatigue includes non-pharmacological approach. Effect size in reducing fatigue in various treatments were summarised in a report by Bower (9). Exercise was more effective than control in reducing fatigue with a mean effect size of -0.27. Psychosocial intervention trials that included fatigue as a primary or secondary outcome have shown reductions in fatigue relative to control, with effective sizes ranging from -0.10 to -0.31. Psychostimulant trials, most of which were conducted among patients with advanced disease and used methylphenidate, suggested that psychostimulants were more effective than placebo in improving fatigue with an effect size of -0.28. Of note, two studies with larger sample size showed no benefit for methylphenidate vs. placebo for improving fatigue (10, 11). The application of non-pharmacological approach in our local patients was even more limited. A pilot study of 26 patients receiving palliative care in Shatin Hospital showed a mean change score of 0.5 (1.862) of improvement in Brief Fatigue Inventory (BFI) Q3 after two weeks of in-patient multidisciplinary care (unpublished data). The estimated effect size of the pilot study was 0.268 (mean change/SD = 0.5/1.863). Overall, these data suggest that non-pharmacological treatments (e.g. exercise, psychoeducation, support program, cognitive-behavioural therapy) have a mild to moderate effect on improving symptom of fatigue.
Over these few decades, Bright Light Treatment (BLT) has also evolved as a favourable treatment for cancer-related fatigue. BLT is the prescription of artificial bright light over a designated period of time. It was initially developed for the treatment of seasonal affective disorder, and found to be as effective as antidepressants for treatment of depressive symptoms during winter (12). The National Comprehensive Cancer Network (NCCN) guidelines on cancer-related fatigue (13) and a recent review on all treatment options of cancer-related fatigue (14) suggested that BLT is a safe and accessible option.
There are several mechanisms on how light therapy works. Firstly, it works through improving alertness. Healthy subjects who had increasing bright light exposure as compared to dim light would have a rapid effect of decrease in sleepiness and improvement in their performance (15). Secondly, BLT works through improving mood. Efficacy of BLT have been demonstrated in seasonal affective disorder (12), non-seasonal depression (16) and bipolar depression (17). Thirdly, BLT works through regulation of circadian rhythm. Circadian disruptions were demonstrated in 55 community-dwelling cancer patients receiving palliative care (18). Although the cause and effect between exacerbated fatigue and decreased light exposure could not be confirmed, increased fatigue was significantly correlated with decreased light exposure among patients with breast cancer (19). Exposure to bright light in the morning leads to an advance of endogenous circadian rhythms that results in a realignment of these rhythms with the individual's sleep-wake cycle. Therefore, possibly by providing a corrective phase advance with morning BLT, rhythm dysregulation could be corrected resulting in a reduction of fatigue symptom.
Two trials investigated the impact of light therapy on fatigue and QOL in the same group of 39 women with breast cancer undergoing active chemotherapy (20, 21). Results suggest that morning bright light treatment helped prevent the typical worsening of fatigue and quality of life during chemotherapy treatment. Although the light treatment did not improve overall fatigue in this sample, the lack of deterioration in total fatigue during a period where symptoms typically worsen was encouraging. Another study sought to determine the effect of bright light treatment on cancer-related fatigue among 36 post-treatment survivors (22). At the end of the treatment period, patients who had received bright white light therapy were no longer clinically fatigued, whereas 55% of the patients in the active control condition continued to report clinical fatigue. The effects of the bright white light treatment were maintained 3-weeks post-intervention.
A more recent study again focused on cancer survivors (23, 24). The total fatigue score using the Multidimensional Fatigue Symptom Inventory-Short Form showed an effect size of 1.20 in the bright-white-light intervention group and an effect size of 0.93 in the supposing placebo arm dim-red-light group. These were large within group effect size. This study employed BLT as an adjunctive therapy and the participants were not excluded for using their usual medications (including psychotropic medications). A randomised controlled trial in 2007 reported that selective serotonin reuptake inhibitor (SSRI) do not appear to have beneficial effects on cancer-related fatigue, supporting the distinction between fatigue and depression in cancer patients and suggesting that fatigue is not solely a symptom of depression (25).
Bruera and team tried to introduce BLT to patients with advanced cancer and insomnia in out-patient settings (26). One shortcoming of their study was partly due to a high attrition rate especially in the control arm where dim red light was used as placebo. They suggested future studies to incorporate alternative trial designs to improve the adherence.
There is however no data on bright light therapy used in in-patient palliative care settings. Conducting research on patients receiving palliative care has been particularly challenging (27, 28). Barriers include the difficulty in participation due to limitations of serious illness, complex symptoms and clinical instability, resulting in high attrition and missing data. The MOREcare Statement (29) suggested researchers to use measures which are as short and simple as possible.
Despite these limitations, the present evidence suggests that BLT, a safe and easily delivered treatment, may be a clinically feasible and effective intervention to reduce symptom of fatigue in cancer palliative care patients during hospital stay. This study aims to test the feasibility of administering bright light therapy in cancer palliative care patients for the treatment of fatigue.
The fatigue experienced by cancer patients is multi-dimensional. The feeling may be a physical sensation (weakness, tiredness, exhaustion, unable to perform tasks), an affective sensation (low mood, lack of motivation), or a cognitive sensation (lack of concentration, difficulty thinking clearly). This phenomenon is also subject to cultural interpretation therefore there is a need to understand each subject's perception and experience of fatigue within his or her own cultural context (2, 3).
Fatigue is also one of the most under-reported hence under-treated symptoms. Patients may perceive it as a condition to be endured, whereas healthcare workers find it very challenging to assess and treat due to its subjective nature and multidimensional causes. The impairment in self-care capabilities and daily functioning lead to negative effects on desire to continue treatment thus affecting the functional recovery even in patients with a more stable disease status (3-5). The quality of life (QOL) of patients, which is our focus in palliative care service, is heavily reduced (6).
However, evidence-based practice to tackle this distressing problem is still inadequate, and that a one-size fit all approach is unrealistic (7). Various pharmacological options have been examined, but due to limited evidence, no specific drug could be recommended for the treatment of fatigue in palliative care patients in the latest Cochrane review in 2015 (8).
Latest development in management of fatigue includes non-pharmacological approach. Effect size in reducing fatigue in various treatments were summarised in a report by Bower (9). Exercise was more effective than control in reducing fatigue with a mean effect size of -0.27. Psychosocial intervention trials that included fatigue as a primary or secondary outcome have shown reductions in fatigue relative to control, with effective sizes ranging from -0.10 to -0.31. Psychostimulant trials, most of which were conducted among patients with advanced disease and used methylphenidate, suggested that psychostimulants were more effective than placebo in improving fatigue with an effect size of -0.28. Of note, two studies with larger sample size showed no benefit for methylphenidate vs. placebo for improving fatigue (10, 11). The application of non-pharmacological approach in our local patients was even more limited. A pilot study of 26 patients receiving palliative care in Shatin Hospital showed a mean change score of 0.5 (1.862) of improvement in Brief Fatigue Inventory (BFI) Q3 after two weeks of in-patient multidisciplinary care (unpublished data). The estimated effect size of the pilot study was 0.268 (mean change/SD = 0.5/1.863). Overall, these data suggest that non-pharmacological treatments (e.g. exercise, psychoeducation, support program, cognitive-behavioural therapy) have a mild to moderate effect on improving symptom of fatigue.
Over these few decades, Bright Light Treatment (BLT) has also evolved as a favourable treatment for cancer-related fatigue. BLT is the prescription of artificial bright light over a designated period of time. It was initially developed for the treatment of seasonal affective disorder, and found to be as effective as antidepressants for treatment of depressive symptoms during winter (12). The National Comprehensive Cancer Network (NCCN) guidelines on cancer-related fatigue (13) and a recent review on all treatment options of cancer-related fatigue (14) suggested that BLT is a safe and accessible option.
There are several mechanisms on how light therapy works. Firstly, it works through improving alertness. Healthy subjects who had increasing bright light exposure as compared to dim light would have a rapid effect of decrease in sleepiness and improvement in their performance (15). Secondly, BLT works through improving mood. Efficacy of BLT have been demonstrated in seasonal affective disorder (12), non-seasonal depression (16) and bipolar depression (17). Thirdly, BLT works through regulation of circadian rhythm. Circadian disruptions were demonstrated in 55 community-dwelling cancer patients receiving palliative care (18). Although the cause and effect between exacerbated fatigue and decreased light exposure could not be confirmed, increased fatigue was significantly correlated with decreased light exposure among patients with breast cancer (19). Exposure to bright light in the morning leads to an advance of endogenous circadian rhythms that results in a realignment of these rhythms with the individual's sleep-wake cycle. Therefore, possibly by providing a corrective phase advance with morning BLT, rhythm dysregulation could be corrected resulting in a reduction of fatigue symptom.
Two trials investigated the impact of light therapy on fatigue and QOL in the same group of 39 women with breast cancer undergoing active chemotherapy (20, 21). Results suggest that morning bright light treatment helped prevent the typical worsening of fatigue and quality of life during chemotherapy treatment. Although the light treatment did not improve overall fatigue in this sample, the lack of deterioration in total fatigue during a period where symptoms typically worsen was encouraging. Another study sought to determine the effect of bright light treatment on cancer-related fatigue among 36 post-treatment survivors (22). At the end of the treatment period, patients who had received bright white light therapy were no longer clinically fatigued, whereas 55% of the patients in the active control condition continued to report clinical fatigue. The effects of the bright white light treatment were maintained 3-weeks post-intervention.
A more recent study again focused on cancer survivors (23, 24). The total fatigue score using the Multidimensional Fatigue Symptom Inventory-Short Form showed an effect size of 1.20 in the bright-white-light intervention group and an effect size of 0.93 in the supposing placebo arm dim-red-light group. These were large within group effect size. This study employed BLT as an adjunctive therapy and the participants were not excluded for using their usual medications (including psychotropic medications). A randomised controlled trial in 2007 reported that selective serotonin reuptake inhibitor (SSRI) do not appear to have beneficial effects on cancer-related fatigue, supporting the distinction between fatigue and depression in cancer patients and suggesting that fatigue is not solely a symptom of depression (25).
Bruera and team tried to introduce BLT to patients with advanced cancer and insomnia in out-patient settings (26). One shortcoming of their study was partly due to a high attrition rate especially in the control arm where dim red light was used as placebo. They suggested future studies to incorporate alternative trial designs to improve the adherence.
There is however no data on bright light therapy used in in-patient palliative care settings. Conducting research on patients receiving palliative care has been particularly challenging (27, 28). Barriers include the difficulty in participation due to limitations of serious illness, complex symptoms and clinical instability, resulting in high attrition and missing data. The MOREcare Statement (29) suggested researchers to use measures which are as short and simple as possible.
Despite these limitations, the present evidence suggests that BLT, a safe and easily delivered treatment, may be a clinically feasible and effective intervention to reduce symptom of fatigue in cancer palliative care patients during hospital stay. This study aims to test the feasibility of administering bright light therapy in cancer palliative care patients for the treatment of fatigue.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Fatigue
Cancer
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bright light therapy
Bright light therapy (BLT) will be given via a lightbox device in the morning for 30 minutes after waking up. Duration of therapy will be 7 consecutive days.
Group Type
EXPERIMENTAL
bright light therapy
Intervention Type
DEVICE
please see arm description
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
bright light therapy
please see arm description
Intervention Type
DEVICE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adult patient aged 18 years old or above
* Chinese ethnic group
* Diagnosis of incurable cancer
* A score of \>=3 in Brief Fatigue Inventory after a period of standard care
* Chinese ethnic group
* Diagnosis of incurable cancer
* A score of \>=3 in Brief Fatigue Inventory after a period of standard care
Exclusion Criteria
* Patients who are imminently dying
* Patients who are undergoing chemotherapy or radiotherapy
* Patients who have history of epilepsy, brain tumour, brain metastasis
* Patients who are blind or have retinal disease
* Patents who have photosensitive skin condition
* Patients who have history of bipolar disorder as BLT has been suggested to increase the risk of manic swing in patients with bipolar disorder
* Patients who have their dosage of antidepressants adjusted within 6 weeks
* Patients who have difficulties to communicate effectively
* Patients with impaired mental status precluding the completion of the questionnaire (AMT \<5)
* Patients who are unable to give valid consent
* Patients who are undergoing chemotherapy or radiotherapy
* Patients who have history of epilepsy, brain tumour, brain metastasis
* Patients who are blind or have retinal disease
* Patents who have photosensitive skin condition
* Patients who have history of bipolar disorder as BLT has been suggested to increase the risk of manic swing in patients with bipolar disorder
* Patients who have their dosage of antidepressants adjusted within 6 weeks
* Patients who have difficulties to communicate effectively
* Patients with impaired mental status precluding the completion of the questionnaire (AMT \<5)
* Patients who are unable to give valid consent
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Authority, Hong Kong
OTHER_GOV
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tang Heng Joshua
Deparment of Medicine & Geriatrics, Resident, Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heng Joshua Tang
Role: PRINCIPAL_INVESTIGATOR
Hospital Authority
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shatin Hospital
Hong Kong, , Hong Kong
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Hong Kong
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Teunissen SC, Wesker W, Kruitwagen C, de Haes HC, Voest EE, de Graeff A. Symptom prevalence in patients with incurable cancer: a systematic review. J Pain Symptom Manage. 2007 Jul;34(1):94-104. doi: 10.1016/j.jpainsymman.2006.10.015. Epub 2007 May 23.
Reference Type
BACKGROUND
Stone P, Richards M, Hardy J. Fatigue in patients with cancer. Eur J Cancer. 1998 Oct;34(11):1670-6. doi: 10.1016/s0959-8049(98)00167-1.
Reference Type
BACKGROUND
Chan CW, Molassiotis A. The impact of fatigue on Chinese cancer patients in Hong Kong. Support Care Cancer. 2001 Jan;9(1):18-24. doi: 10.1007/s005200000192.
Reference Type
BACKGROUND
Lou Y, Yates P, McCarthy A, Wang H. Fatigue self-management: a survey of Chinese cancer patients undergoing chemotherapy. J Clin Nurs. 2013 Apr;22(7-8):1053-65. doi: 10.1111/jocn.12174.
Reference Type
BACKGROUND
Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, Itri LM, Johnson DH, Miaskowski C, Scherr SL, Portenoy RK, Vogelzang NJ. Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist. 2000;5(5):353-60. doi: 10.1634/theoncologist.5-5-353.
Reference Type
BACKGROUND
Gupta D, Lis CG, Grutsch JF. The relationship between cancer-related fatigue and patient satisfaction with quality of life in cancer. J Pain Symptom Manage. 2007 Jul;34(1):40-7. doi: 10.1016/j.jpainsymman.2006.10.012. Epub 2007 May 25.
Reference Type
BACKGROUND
Dean A. The holistic management of fatigue within palliative care. Int J Palliat Nurs. 2019 Aug 2;25(8):368-376. doi: 10.12968/ijpn.2019.25.8.368.
Reference Type
BACKGROUND
Mucke M; Mochamat; Cuhls H, Peuckmann-Post V, Minton O, Stone P, Radbruch L. Pharmacological treatments for fatigue associated with palliative care. Cochrane Database Syst Rev. 2015 May 30;2015(5):CD006788. doi: 10.1002/14651858.CD006788.pub3.
Reference Type
BACKGROUND
Bower JE. Cancer-related fatigue--mechanisms, risk factors, and treatments. Nat Rev Clin Oncol. 2014 Oct;11(10):597-609. doi: 10.1038/nrclinonc.2014.127. Epub 2014 Aug 12.
Reference Type
BACKGROUND
Lower EE, Fleishman S, Cooper A, Zeldis J, Faleck H, Yu Z, Manning D. Efficacy of dexmethylphenidate for the treatment of fatigue after cancer chemotherapy: a randomized clinical trial. J Pain Symptom Manage. 2009 Nov;38(5):650-62. doi: 10.1016/j.jpainsymman.2009.03.011.
Reference Type
BACKGROUND
Bruera E, Yennurajalingam S, Palmer JL, Perez-Cruz PE, Frisbee-Hume S, Allo JA, Williams JL, Cohen MZ. Methylphenidate and/or a nursing telephone intervention for fatigue in patients with advanced cancer: a randomized, placebo-controlled, phase II trial. J Clin Oncol. 2013 Jul 1;31(19):2421-7. doi: 10.1200/JCO.2012.45.3696. Epub 2013 May 20.
Reference Type
BACKGROUND
Golden RN, Gaynes BN, Ekstrom RD, Hamer RM, Jacobsen FM, Suppes T, Wisner KL, Nemeroff CB. The efficacy of light therapy in the treatment of mood disorders: a review and meta-analysis of the evidence. Am J Psychiatry. 2005 Apr;162(4):656-62. doi: 10.1176/appi.ajp.162.4.656.
Reference Type
BACKGROUND
NCCN Guidelines Version 2.2018 Cancer-Related Fatigue, page 26/64. 2018.
Reference Type
BACKGROUND
Thong MSY, van Noorden CJF, Steindorf K, Arndt V. Cancer-Related Fatigue: Causes and Current Treatment Options. Curr Treat Options Oncol. 2020 Feb 5;21(2):17. doi: 10.1007/s11864-020-0707-5.
Reference Type
BACKGROUND
Phipps-Nelson J, Redman JR, Dijk DJ, Rajaratnam SM. Daytime exposure to bright light, as compared to dim light, decreases sleepiness and improves psychomotor vigilance performance. Sleep. 2003 Sep;26(6):695-700. doi: 10.1093/sleep/26.6.695.
Reference Type
BACKGROUND
Lam RW, Levitt AJ, Levitan RD, Michalak EE, Cheung AH, Morehouse R, Ramasubbu R, Yatham LN, Tam EM. Efficacy of Bright Light Treatment, Fluoxetine, and the Combination in Patients With Nonseasonal Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jan;73(1):56-63. doi: 10.1001/jamapsychiatry.2015.2235.
Reference Type
BACKGROUND
Sit DK, McGowan J, Wiltrout C, Diler RS, Dills JJ, Luther J, Yang A, Ciolino JD, Seltman H, Wisniewski SR, Terman M, Wisner KL. Adjunctive Bright Light Therapy for Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2018 Feb 1;175(2):131-139. doi: 10.1176/appi.ajp.2017.16101200. Epub 2017 Oct 3.
Reference Type
BACKGROUND
Bernatchez MS, Savard J, Ivers H. Disruptions in sleep-wake cycles in community-dwelling cancer patients receiving palliative care and their correlates. Chronobiol Int. 2018 Jan;35(1):49-62. doi: 10.1080/07420528.2017.1381615. Epub 2017 Nov 16.
Reference Type
BACKGROUND
Liu L, Marler MR, Parker BA, Jones V, Johnson S, Cohen-Zion M, Fiorentino L, Sadler GR, Ancoli-Israel S. The relationship between fatigue and light exposure during chemotherapy. Support Care Cancer. 2005 Dec;13(12):1010-7. doi: 10.1007/s00520-005-0824-5. Epub 2005 Apr 29.
Reference Type
BACKGROUND
Jeste N, Liu L, Rissling M, Trofimenko V, Natarajan L, Parker BA, Ancoli-Israel S. Prevention of quality-of-life deterioration with light therapy is associated with changes in fatigue in women with breast cancer undergoing chemotherapy. Qual Life Res. 2013 Aug;22(6):1239-44. doi: 10.1007/s11136-012-0243-2. Epub 2012 Aug 3.
Reference Type
BACKGROUND
Ancoli-Israel S, Rissling M, Neikrug A, Trofimenko V, Natarajan L, Parker BA, Lawton S, Desan P, Liu L. Light treatment prevents fatigue in women undergoing chemotherapy for breast cancer. Support Care Cancer. 2012 Jun;20(6):1211-9. doi: 10.1007/s00520-011-1203-z. Epub 2011 Jun 11.
Reference Type
BACKGROUND
Redd WH, Valdimarsdottir H, Wu LM, Winkel G, Byrne EE, Beltre MA, Liebman ES, Erazo T, Hayes JA, Isola L, Scigliano E, Meschian Y, Lutgendorf S, Ancoli-Israel S. Systematic light exposure in the treatment of cancer-related fatigue: a preliminary study. Psychooncology. 2014 Dec;23(12):1431-4. doi: 10.1002/pon.3553. Epub 2014 May 2. No abstract available.
Reference Type
BACKGROUND
Johnson JA, Garland SN, Carlson LE, Savard J, Simpson JS, Ancoli-Israel S, Campbell TS. The LITE study: Rationale and protocol for a randomized controlled trial of light therapy for cancer-related fatigue in cancer survivors. Contemp Clin Trials. 2016 Jul;49:166-73. doi: 10.1016/j.cct.2016.07.004. Epub 2016 Jul 6.
Reference Type
BACKGROUND
Johnson JA, Garland SN, Carlson LE, Savard J, Simpson JSA, Ancoli-Israel S, Campbell TS. Bright light therapy improves cancer-related fatigue in cancer survivors: a randomized controlled trial. J Cancer Surviv. 2018 Apr;12(2):206-215. doi: 10.1007/s11764-017-0659-3. Epub 2017 Nov 10.
Reference Type
BACKGROUND
Stockler MR, O'Connell R, Nowak AK, Goldstein D, Turner J, Wilcken NR, Wyld D, Abdi EA, Glasgow A, Beale PJ, Jefford M, Dhillon H, Heritier S, Carter C, Hickie IB, Simes RJ; Zoloft's Effects on Symptoms and survival Time Trial Group. Effect of sertraline on symptoms and survival in patients with advanced cancer, but without major depression: a placebo-controlled double-blind randomised trial. Lancet Oncol. 2007 Jul;8(7):603-12. doi: 10.1016/S1470-2045(07)70148-1.
Reference Type
BACKGROUND
Dev R D-GM, De La Cruz M, Rhondali W, Hui D, Bruer E. Feasibility of a Randomized Controlled Trial of Light Therapy in Cancer Patients with Insomnia. Journal of Palliative Care & Medicine. 2014;04(04).
Reference Type
BACKGROUND
Chen EK, Riffin C, Reid MC, Adelman R, Warmington M, Mehta SS, Pillemer K. Why is high-quality research on palliative care so hard to do? Barriers to improved research from a survey of palliative care researchers. J Palliat Med. 2014 Jul;17(7):782-7. doi: 10.1089/jpm.2013.0589. Epub 2014 Jun 2.
Reference Type
BACKGROUND
Higginson IJ. Research challenges in palliative and end of life care. BMJ Support Palliat Care. 2016 Mar;6(1):2-4. doi: 10.1136/bmjspcare-2015-001091. No abstract available.
Reference Type
BACKGROUND
Higginson IJ, Evans CJ, Grande G, Preston N, Morgan M, McCrone P, Lewis P, Fayers P, Harding R, Hotopf M, Murray SA, Benalia H, Gysels M, Farquhar M, Todd C; MORECare. Evaluating complex interventions in end of life care: the MORECare statement on good practice generated by a synthesis of transparent expert consultations and systematic reviews. BMC Med. 2013 Apr 24;11:111. doi: 10.1186/1741-7015-11-111.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FatigueBLT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases
NCT07202273
RECRUITING
NA
SBRT for Liver Cancer Before Liver Transplantation
NCT04186234
ACTIVE_NOT_RECRUITING
NA
Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC
NCT02688036
UNKNOWN
PHASE3
Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer
NCT05802654
NOT_YET_RECRUITING
NA
CT-Based Versus Conventional Simulation for Palliative Radiotherapy of Non-Small Cell Lung Cancer
NCT00862030
COMPLETED
Stereotactic Radiotherapy (SBRT) of Lung Metastasis
NCT01803542
RECRUITING
PHASE2
A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases
NCT06065449
RECRUITING
PHASE3
Clinical Trial of Radiotherapy in Treating Primary Hepatocellular Carcinoma
NCT03614546
UNKNOWN
NA
2D-radiotherapy in Palliation of Advanced Esophageal Cancer
NCT03922152
COMPLETED
NA
Evaluate the Effectiveness of Low Level Laser Therapy (LLT) Combined With Acupuncture
NCT02686203
UNKNOWN
NA
Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases
NCT06542159
RECRUITING
PHASE2
Transcutaneous Electrical Acupoint Stimulation for Non-small Cell Lung Cancer Patients
NCT02663492
UNKNOWN
NA
Prognosis of Inpatients Evaluated for Palliative Radiotherapy
NCT02312791
COMPLETED
MR-informed Stereotactic Radiotherapy for Treatment of Ultracentral Lung Tumours Utilising a Dedicated MR-simulator for Daily Adaptation Followed by CBCT-guided Treatment Delivery
NCT06815289
RECRUITING
NA
Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis
NCT02699697
COMPLETED
NA
Palliative 3-Dimensional Conformal Radiation Therapy in Reducing Radiation Side Effects in Patients With Lung Cancer. ICORG 06-34
NCT01176487
COMPLETED
NA
Palliative Radiotherapy (RT) for Liver Metastases (Mets) and Hepatocellular Carcinoma (HCC)(COLD 4)
NCT00923897
COMPLETED
PHASE2
Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study
NCT01836692
COMPLETED
NA
Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)
NCT05224934
RECRUITING
NA
Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Lung Cancer: A Single-Blind Randomized Trial
NCT03077854
UNKNOWN
NA
Radiotherapy for Extracranial Oligometastatic Breast Cancer
NCT04646564
RECRUITING
PHASE3
Hypofractionated Radiotherapy (Stereotactic) Versus Conventional Radiotherapy for Inoperable Early Stage I Non-small Cell Lung Cancer (NSCLC)
NCT01014130
UNKNOWN
PHASE3
Stereotactic Radiotherapy With Different Fractionation Modes for the Early Lung Cancer
NCT05802641
UNKNOWN
Neoadjuvant SBRT Combined With Lenvatinib and Pucotenlimab for Resectable Hepatocellular Carcinoma
NCT06524466
ACTIVE_NOT_RECRUITING
PHASE2