Feasibility of Adjunctive BLT for Amelioration of Fatigue in Chinese Cancer Patients Admitted to a Palliative Care Unit
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04525924|
Recruitment Status : Recruiting
First Posted : August 25, 2020
Last Update Posted : September 29, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Fatigue Cancer||Device: bright light therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of Adjunctive Bright Light Therapy (BLT) for Amelioration of Fatigue in Chinese Cancer Patients Admitted to a Palliative Care Unit|
|Actual Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: 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.
Device: bright light therapy
please see arm description
- Rate of declined particilation in the study [ Time Frame: At screening stage ]Rate of approached potential subjects who declined participation in the study
- Attrition rate [ Time Frame: 1 week of the intervention ]Rate of subject drop out (all cause)
- Change in brief fatigue inventory [ Time Frame: Pre- and post- the 1-week intervention ]Change of scoreing of the brief fatigue inventory (BFI) from baseline to end of treatment. BFI is a 9-item questionnaire measured in 11-point Likert scale. It evaluates the level of present, overall and worst fatigue together with its interference to patients' general activity, mood, walking ability, normal work, relationships with other people and enjoyment of life during the past 24 hours. A higher score means a worse outcome.
- Change in Pittsburgh Sleep Quality Index [ Time Frame: Pre- and post- the 1-week intervention ]Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to end of treatment. PSQI is a 19-item self-report measure to assess sleep quality. It consists of 7 components measuring duration of sleep, sleep disturbance, sleep latency, day dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and whether a person needs medications in order to sleep. A global score > 5 indicates that a patient reports severe difficulties in at least 2 domains or moderate difficulties in more than 3 areas.
- Change in Hospital Anxiety and Depression Scale [ Time Frame: Pre- and post- the 1-week intervention ]Change in Hospital Anxiety and Depression Scale (HADS) from baseline to end of treatment. HADS is comprised of 14 questions which assess level of depression and anxiety. Each item is scored from 0-3, thus the patient can score between 0-21 for either anxiety or depression. A literature review identified a cut-off point of 8/21 for anxiety or depression.
- Change in McGill Quality of Life Questionnaire - Hong Kong [ Time Frame: Pre- and post- the 1-week intervention ]Change in McGill Quality of Life Questionnaire - Hong Kong (MQOL-HK) from baseline to end of treatment. It assesses a patient's QOL in 5 domains (physical, psychological, existential, support and sexual functioning). The physical symptoms subscale allows patients to describe their 3 most disturbing symptoms and rate them. Patients can also rate their perceived QOL as a single item score. Responses are measured in 11-point Likert scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04525924
|Contact: Heng Joshua Tang||(852) firstname.lastname@example.org|
|Hong Kong, Hong Kong|
|Contact: Heng Joshua Tang 57967529 email@example.com|
|Principal Investigator:||Heng Joshua Tang||Hospital Authority|