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

NCT04525924 | Unknown

• 1 other identifier: FatigueBLT
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Cancer

Keywords

fatigue; cancer; palliative care; BLT; bright light therapy; feasibility

Outcome Measures

Primary Outcomes (3)

• Rate of declined particilation in the study

  Rate of approached potential subjects who declined participation in the study

  At screening stage

• Attrition rate

  Rate of subject drop out (all cause)

  1 week of the intervention

• Change in brief fatigue inventory

  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.

  Pre- and post- the 1-week intervention

Secondary Outcomes (3)

• Change in Pittsburgh Sleep Quality Index

  Pre- and post- the 1-week intervention

• Change in Hospital Anxiety and Depression Scale

  Pre- and post- the 1-week intervention

• Change in McGill Quality of Life Questionnaire - Hong Kong

  Pre- and post- the 1-week intervention

Study Arms (1)

Bright light therapy

EXPERIMENTAL

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

Interventions

bright light therapy DEVICE

please see arm description

Bright light therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead

Study Sites (1)

Shatin Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

Fatigue; Neoplasms

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Heng Joshua Tang

  Hospital Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heng Joshua Tang

CONTACT

(852) 57967529; th372@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deparment of Medicine & Geriatrics, Resident, Principal Investigator

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 25, 2020
• Study Start: August 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)