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Trial registered on ANZCTR


Registration number
ACTRN12622001035718
Ethics application status
Approved
Date submitted
8/07/2022
Date registered
25/07/2022
Date last updated
20/07/2023
Date data sharing statement initially provided
25/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Light Therapy for Cancer Patients Undertaking Chemotherapy
Scientific title
LightTherapyCa: The Therapeutic Utility of Green-Blue Light Therapy on Sleep Disturbances in a Mixed Group of Adults with Cancer Treated with Chemotherapy Agents: A Randomised Controlled Trial
Secondary ID [1] 306764 0
Nil
Universal Trial Number (UTN)
U1111-1276-2814
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 325777 0
Condition category
Condition code
Cancer 323114 323114 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomly allocated to the intervention group (as opposed to comparator group) will receive four weeks of green-blue light therapy plus sleep health guidelines while undertaking chemotherapy.

Green-Blue Light Therapy: Green-blue light therapy will be delivered using wearable light therapy glasses (Re-Timer) for the duration of the intervention (four weeks). Participants will wear the light therapy glasses in their own home immediately upon waking in the morning for 30 minutes continuously at 500nm (max= 500nm, 230 µW/cm2, 506 lux), which is the highest setting on the glasses. Participants will be instructed by the study investigators on how to use the Re-Timer glasses according to manufacturer recommendations and will need to demonstrate appropriate use of the glasses. In cases where participants use prescription glasses, they will be asked to wear the light therapy glasses over the top. Written instructions will be provided as a reference for participants. For the initial three mornings of the intervention, participants will receive a phone call or email asking to provide feedback on any negative effects experienced while wearing the light therapy glasses. Participants will then be instructed to report any negative effects as required throughout the study period.

Sleep Health Guidelines: Sleep health guidelines will be provided to the participants to take home and will be available to refer to at the commencement of the intervention period and the remainder of the study period. Sleep health guidelines will consist of evidence-based recommendations targeting improved sleep health. Recommendations will be adapted from resources provided by the National Sleep Foundation, Sleep Health Foundation and Buysse (2014). These guidelines will focus on recommendations promoting improved sleep health, including the implementation of night-time and daily routines, as well as recommendations regarding sleep environment. Research staff will deliver the sleep hygiene guidelines to study participants either in person at the participants treating centre or via Microsoft Teams. An individualised sleep report based off each study participants baseline findings will be used to personalise the sleep health guidelines to each participant. This will ensure that participants follow the sleep health recommendations that are most pertinent to the individual's unique behaviours and environment.

Adherence to the intervention will be recorded using an intervention diary.
Intervention code [1] 323981 0
Treatment: Devices
Comparator / control treatment
Participant randomly allocated to the comparator group (as opposed to the intervention group) will receive sleep hygiene guidance for four weeks. Following the completion of the trial period, participants randomised to the sleep hygiene group will be given the opportunity to undertake the green-blue light therapy treatment.

Sleep Health Guidelines: Sleep health guidelines will be provided to the participants to take home and will be available to refer to at the commencement of the intervention period and the remainder of the study period. Sleep health guidelines will consist of evidence-based recommendations targeting improved sleep health. Recommendations will be adapted from resources provided by the National Sleep Foundation. Sleep Health Foundation and Buysse (2014). These guidelines will focus on recommendations promoting improved sleep health, including the implementation of night-time and daily routines, as well as recommendations regarding sleep environment. Research staff will deliver the sleep health guidelines to study participants either in person at the participants treating centre or via Microsoft Teams. An individualised sleep report, based off each study participants baseline findings, will be used to personalise the sleep health guidelines to each participant. This will ensure that participants follow the sleep health recommendations that are most pertinent to the individual's unique behaviours and environment.
Control group
Active

Outcomes
Primary outcome [1] 331948 0
The primary outcome for this trial is insomnia severity as assessed by the Insomnia Severity Index (ISI).
Timepoint [1] 331948 0
Insomnia severity will be evaluated using the Insomnia Severity Index (ISI) prior to study interventions, following study interventions (primary endpoint) and following a four-week washout period.
Secondary outcome [1] 411692 0
Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 411692 0
Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index prior to study interventions, following study interventions and following a four week washout period.
Secondary outcome [2] 411693 0
Daytime sleepiness will be evaluated using the Epworth Sleepiness Scale.
Timepoint [2] 411693 0
Daytime sleepiness will be evaluated using the Epworth Sleepiness Scale prior to study interventions, following study interventions and following a four-week washout period.
Secondary outcome [3] 411694 0
Sleep environment will be assessed using the Sleep Environment Questionnaire.
Timepoint [3] 411694 0
Sleep environment will be assessed using the Sleep Environment Questionnaire prior to study interventions, following study interventions and following a four week washout period.
Secondary outcome [4] 411695 0
Sleep-wake behaviour will be assessed using the Consensus Sleep Diary.
Timepoint [4] 411695 0
Sleep-wake behaviour will be assessed using the Consensus Sleep Diary prior to study interventions, following study interventions and following a four week washout period.
Secondary outcome [5] 411696 0
Sleep-wake behaviour will be evaluated using wrist-worn actigraphy.
Timepoint [5] 411696 0
Sleep-wake behaviour will be evaluated using wrist-worn actigraphy prior to study interventions, following study interventions and following a four week washout period.
Secondary outcome [6] 411697 0
Fatigue severity will be evaluated using the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-Fatigue) questionnaire.
Timepoint [6] 411697 0
Fatigue severity will be evaluated using the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-Fatigue) questionnaire prior to study interventions. following study interventions and following a four week washout period.
Secondary outcome [7] 411698 0
Fatigue severity and its impact on activities of daily living will be assessed using the Brief Fatigue Inventory. This is a composite outcome.
Timepoint [7] 411698 0
Fatigue severity and its impact on activities of daily living will be assessed using the Brief Fatigue Inventory prior to study interventions, following study interventions and following a four week washout period.
Secondary outcome [8] 411699 0
Mood state will be evaluated using the Depression Anxiety Stress Scale (DASS-21).
Timepoint [8] 411699 0
Mood state will be evaluated using the Depression Anxiety Stress Scale (DASS-21) prior to study interventions, following study interventions and following a four week washout period.
Secondary outcome [9] 411700 0
Quality of life will be evaluated using the European Organisation Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
Timepoint [9] 411700 0
Quality of life will be evaluated using the European Organisation Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) prior to study interventions, following study interventions and following a four week washout period.
Secondary outcome [10] 411701 0
Temporal fluctuations in fatigue will be evaluated using a fatigue visual analogue scale (0-10).
Timepoint [10] 411701 0
Temporal fluctuations in fatigue will be evaluated using a fatigue visual analogue scale (0-10) thrice daily for one week prior (morning (08:00am-11:00am), early afternoon (12:00pm-15:00pm) and evening/night- time (17:00pm-20:00pm)) prior to study interventions, following study interventions and following a four-week washout period.
Secondary outcome [11] 411702 0
Temporal fluctuations in mood state will be evaluated using a depressive mood state visual analogue scale (0-10).
Timepoint [11] 411702 0
Temporal fluctuations in mood state will be evaluated using a depressive mood state visual analogue scale (0-10) thrice daily for one week prior (morning (08:00am-11:00am), early afternoon (12:00pm- 15:00pm) and evening/night-time (17:00pm-20:00pm)) prior to study interventions, following study interventions and following a four week washout period.
Secondary outcome [12] 411703 0
Temporal fluctuations in daytime sleepiness will be evaluated using a visual analogue scale.
Timepoint [12] 411703 0
Temporal fluctuations in daytime sleepiness will be evaluated using a visual analogue scale (0-10) thrice daily for one week prior (morning (08:00am-11:00am), early afternoon (12:00pm-15:00pm) and evening/night-time (17:00pm-20:00pm)) prior to study interventions, following study interventions and following a four week washout period.
Secondary outcome [13] 411704 0
Perceived barriers and enablers, positive and negative aspects of study interventions will be explored using a semi-structured interview. This is a composite outcome.
Timepoint [13] 411704 0
Perceived barriers and enablers, positive and negative aspects of study interventions will be explored using a semi-structured interview following the completion of the intervention period.
Secondary outcome [14] 411705 0
Ambient light and temperature will be assessed using HOBO data loggers. This will be assessed as a composite outcome.
Timepoint [14] 411705 0
Ambient light and temperature will be assessed using HOBO data loggers prior to study interventions, following study interventions and following a four week washout period.

Eligibility
Key inclusion criteria
1. Patients who have received a cancer diagnosis within the last six months and are receiving or about to receive chemotherapy for cancer (with or without other therapies including immunotherapy) and with no or minimal underlying symptoms from their cancer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Visual abnormalities that may interfere with green-blue light therapy, including cataracts or narrow- angle glaucoma.
2) Intention to undertake night shift work and/or trans meridian travel during the study, or within the four weeks leading up to the study.
3) Diagnosed sleep apnoea, sleep-wake disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to intervention groups by an independent biostatistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using simple block randomisation using a table created by computer software (i.e. computerised sequence generation). Sequences will be generated using ISI values as a stratification factor.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Previous evidence suggests a moderate effect size (d· -0,54) for changes in sleep disturbances/insomnia symptoms in a mixed group of fatigued cancer survivors (Garland et al.. 2020). In consultation with a biostatistician, this value was inputted into G·Power 3.1.9,7 using a priori power analysis and yielded a sample size of seventy-four participants, which is needed to detect a small to medium effect size for changes in the primary outcome (effect size f..175, Bonferroni corrected a-.0038 and power (1-B),80%). Accounting for attrition rates up to 20%, an estimated 90 participants will be required for this study. The primary, secondary, and tertiary outcomes will be assessed following the principles of an intention-to-treat approach. An intention-to treat approach allows the inclusion of missing data without any imputations (e.g. last observation being carried forward). For the primary, secondary, and tertiary outcomes, Shapiro-Wilk tests will be used to assess normality assumptions. A mixed-model repeated measures ANOVA will be performed to assess the changes observed in secondary and tertiary outcomes throughout the duration of the study. Analyses will be adjusted for baseline levels and potential confounding factors if necessary. Statistical significance will be set at an alpha level of 0.05, while effect sizes will be calculated and interpreted using the following criteria: d=0.2 small, d=0.5 moderate and d=0.8 large. Themes and sub- themes will be derived from the semi-structured interview recordings using a thematic analysis. NVivo 12 software will be used to undertake this thematic analysis. Derived themes and sub-themes will be reviewed by multiple investigators to best ensure accuracy.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/03/2023
Actual
22/02/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
27/01/2025
Actual
Sample size
Target
90
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 22779 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 38060 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 311104 0
University
Name [1] 311104 0
Edith Cowan University
Country [1] 311104 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive. Joondalup WA 6027, Perth, Western Australia
Country
Australia
Secondary sponsor category [1] 312433 0
None
Name [1] 312433 0
Address [1] 312433 0
Country [1] 312433 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310635 0
St John of God Hospital (Subiaco) Human Research Ethics Committee
Ethics committee address [1] 310635 0
Ethics committee country [1] 310635 0
Australia
Date submitted for ethics approval [1] 310635 0
06/01/2022
Approval date [1] 310635 0
19/08/2022
Ethics approval number [1] 310635 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118342 0
Dr Travis Cruickshank
Address 118342 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Perth, Western Australia
Country 118342 0
Australia
Phone 118342 0
+61 8 6304 3416
Fax 118342 0
Email 118342 0
t.cruickshank@ecu.edu.au
Contact person for public queries
Name 118343 0
Travis Cruickshank
Address 118343 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Perth, Western Australia
Country 118343 0
Australia
Phone 118343 0
+61 8 6304 3416
Fax 118343 0
Email 118343 0
t.cruickshank@ecu.edu.au
Contact person for scientific queries
Name 118344 0
Travis Cruickshank
Address 118344 0
Edith Cowan University, 270 Joondalup Drive, Joondalup, 6027, Perth, Western Australia
Country 118344 0
Australia
Phone 118344 0
+61 8 6304 3416
Fax 118344 0
Email 118344 0
t.cruickshank@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data of published results may be shared upon reasonable request following completion of the study and publishing of findings.
When will data be available (start and end dates)?
Data may be available beginning three months and ending five years following the main results publication.
Available to whom?
De-identified participant data will be available following publication to researchers upon reasonable request.
Available for what types of analyses?
Data will be made available for the type of analysis outlined in the expression of interest/proposal document that is submitted to study investigators.
How or where can data be obtained?
Access to data will be subject to approval by the research team. Once approved, data will be shared via email correspondence with a member of the research team (please contact the Chief Investigator, Dr Travis Cruickshank, on t.cruickshank@ecu.edu.au for further information).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.