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Feasibility of Adjunctive BLT for Amelioration of Fatigue in Chinese Cancer Patients Admitted to a Palliative Care Unit

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ClinicalTrials.gov Identifier: NCT04525924
Recruitment Status : Recruiting
First Posted : August 25, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Tang Heng Joshua, Hospital Authority, Hong Kong

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Rate of declined particilation in the study [ Time Frame: At screening stage ]
    Rate of approached potential subjects who declined participation in the study

  2. Attrition rate [ Time Frame: 1 week of the intervention ]
    Rate of subject drop out (all cause)

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

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


Contacts
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Contact: Heng Joshua Tang (852) 57967529 th372@ha.org.hk

Locations
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Hong Kong
Shatin Hospital Recruiting
Hong Kong, Hong Kong
Contact: Heng Joshua Tang    57967529    th372@ha.org.hk   
Sponsors and Collaborators
Hospital Authority, Hong Kong
Investigators
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Principal Investigator: Heng Joshua Tang Hospital Authority
Publications:
NCCN Guidelines Version 2.2018 Cancer-Related Fatigue, page 26/64. 2018.
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).

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Responsible Party: Tang Heng Joshua, Deparment of Medicine & Geriatrics, Resident, Principal Investigator, Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier: NCT04525924    
Other Study ID Numbers: FatigueBLT
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tang Heng Joshua, Hospital Authority, Hong Kong:
fatigue
cancer
palliative care
BLT
bright light therapy
feasibility
Additional relevant MeSH terms:
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Fatigue