Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001721291
Ethics application status
Approved
Date submitted
30/08/2018
Date registered
18/10/2018
Date last updated
7/07/2020
Date data sharing statement initially provided
7/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding of the efficacy of recording a diary of things for which one is grateful in the reduction of suffering in terminally-ill patients.
Scientific title
Understanding the efficacy of gratitude journaling in the amelioration of suffering in palliative care patients
Secondary ID [1] 295938 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
all cancer types of patients 309443 0
terminally ill patients 309444 0
Condition category
Condition code
Public Health 308286 308286 0 0
Health service research
Cancer 308797 308797 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
80 adult palliative care patients aged 18 and above will be recruited through random sampling in University Malaya, Malaysia. Patients who are not interested to enroll or confused (according to confusion assessment method) will be excluded from the study. Informed consent will be obtained from all participants. Demographic data of the patients will be collected.


All participants will be interview face-to-face by me using Hospital Anxiety and Depression Scale (HADS), GQ-6 form, and the Suffering Pictogram. HADS comprises 14 items, seven of which relate to anxiety symptoms and seven to depressive symptoms. Each item is coded from 0 to 3. The scores for anxiety and depression can therefore vary from 0 to 21, depending on the presence and severity of the symptoms. Baseline score of the scale will be collected.

After that, patients will then be randomized and divided into 2 groups – the control group and the intervention group.

The control group (normal journaling) will receive standard care, which means they will need to chart the suffering score on Day 1 and Day 7 on the suffering score chart. The suffering score ranges from 0-10 (0 = no suffering, 10 = worst possible suffering). The suffering score will be plotted at the suffering chart. Additionally patients will be required to write down the things that happen around them on a daily basis 3 times a day for 7 days in a diary (provided by me). It can be as simple as news headlines, or a joke you heard from the nurse. The intervention group will receive standard care too, which means they will need to chart the suffering score on Day 1 and Day 7 on the suffering score chart as well. After that, the intervention group will be instructed to keep a diary that record 3 things that they are grateful for on a daily basis for seven days (Gratitude journaling).


Participants will be given the following instructions: “For these seven days you are required to write down and record 3 things for which you are grateful on a daily basis. Think back over your day and include anything, no matter small or great, which was a source of gratitude that day. Make the list personal, and try to think of different things each day.” There will not be any specific requirements for the length of the text (how many words or lines written), time spent journaling (minutes per day), or set a daily schedule (e.g., having entries occur in morning or evening).
To monitor the adherence, the researcher will pay daily visit to the participant to remind on the diary charting.
Intervention code [1] 312263 0
Behaviour
Comparator / control treatment
The control group will receive standard care (normal journaling), which means they will need to chart the suffering score on Day 1 and Day 7 on the suffering score chart. The suffering score ranges from 0-10 (0 = no suffering, 10 = worst possible suffering). Additionally patients will be required to write down the things that happen around them on a daily basis 3 times a day for 7 days in a diary (provided by me).
Control group
Placebo

Outcomes
Primary outcome [1] 307257 0
(a) Suffering score difference using suffering score chart for intervention arm vs control arm
Timepoint [1] 307257 0
7 days post randomization
Primary outcome [2] 307258 0
(b) GQ6-form score differences for intervention arm vs control arm
Timepoint [2] 307258 0
7 days post randomization
Secondary outcome [1] 351294 0
HADS score differences for intervention arm vs control arm
Timepoint [1] 351294 0
7 days post randomization
Secondary outcome [2] 352848 0
suffering pictogram score difference for intervention arm vs control arm
Timepoint [2] 352848 0
7 days post randomization

Eligibility
Key inclusion criteria
Adult palliative care patients age 18 years old and above will be recruited from University of Malaya Medical Center.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are not interested to enroll or confused (according to confusion assessment method) will be excluded from the study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
nil known
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The calculation of sample size is based on the assumption below: assuming an SD of approximately 4 units for both the baseline and 1-week measurements of suffering and a 20% dropout rate, an initial sample size of 80 participants per treatment group was expected to provide approximately 80% power to detect a difference of approximately 3 units in mean change in suffering scores between groups, with a two-sided significant level of .05.

Analysis of data will be via SPSS version 22.0

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2019
Actual
31/01/2019
Date of last participant enrolment
Anticipated
28/02/2020
Actual
1/12/2019
Date of last data collection
Anticipated
5/03/2020
Actual
31/12/2019
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 20819 0
Malaysia
State/province [1] 20819 0
kuala lumpur

Funding & Sponsors
Funding source category [1] 300536 0
Self funded/Unfunded
Name [1] 300536 0
tan ting ting
Country [1] 300536 0
Malaysia
Primary sponsor type
Individual
Name
tan ting ting
Address
Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 300020 0
None
Name [1] 300020 0
NONE
Address [1] 300020 0
Country [1] 300020 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301329 0
University of Malaya Medical Centre
Ethics committee address [1] 301329 0
Ethics committee country [1] 301329 0
Malaysia
Date submitted for ethics approval [1] 301329 0
18/10/2017
Approval date [1] 301329 0
10/11/2017
Ethics approval number [1] 301329 0
2017917-5573

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3065 3065 0 0
/AnzctrAttachments/375895-MREC.pdf (Ethics approval)
Attachments [2] 3066 3066 0 0
/AnzctrAttachments/375895-HADS.pdf (Supplementary information)
Attachments [3] 3067 3067 0 0
/AnzctrAttachments/375895-PatientIS.docx (Participant information/consent)
Attachments [4] 3068 3068 0 0
/AnzctrAttachments/375895-protocol oct 07.doc (Protocol)
Attachments [5] 3069 3069 0 0
/AnzctrAttachments/375895-suffering score chart.pdf (Supplementary information)
Attachments [6] 3168 3168 0 0
/AnzctrAttachments/375895-The Gratitude Questionnaire.docx (Supplementary information)

Contacts
Principal investigator
Name 86638 0
Miss tan ting ting
Address 86638 0
University Malaya
Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 86638 0
Malaysia
Phone 86638 0
+60129130109
Fax 86638 0
Email 86638 0
[email protected]
Contact person for public queries
Name 86639 0
tan ting ting
Address 86639 0
University Malaya
Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 86639 0
Malaysia
Phone 86639 0
+60129130109
Fax 86639 0
Email 86639 0
[email protected]
Contact person for scientific queries
Name 86640 0
tan ting ting
Address 86640 0
University Malaya
Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 86640 0
Malaysia
Phone 86640 0
+60129130109
Fax 86640 0
Email 86640 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.