Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001091796p
Ethics application status
Submitted, not yet approved
Date submitted
1/08/2022
Date registered
8/08/2022
Date last updated
8/08/2022
Date data sharing statement initially provided
8/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot feasibility trial of web-based mindfulness intervention for adolescent and young people with cancer
Scientific title
A pilot feasibility trial of web-based mindfulness intervention for adolescent and young people with cancer
Secondary ID [1] 306988 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 326107 0
Condition category
Condition code
Cancer 323425 323425 0 0
Any cancer
Mental Health 324398 324398 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention in this study is a web- based mindfulness interactive self-paced modules consisting of case study videos, audio meditations, reflective journaling, and self-check activities. This module is influenced by a self-help workbook ‘Take in the Good: Skills for staying positive and living your best life’ by Gina M Biegel and modified for young people with cancer by researchers in this project with feedback from young people, care givers, healthcare providers and parents through a user-centred approach. The intervention will be made available through a web link and as the mobile application. There are six modules and each focuses on underpinning mindfulness quality with case study focusing on cancer related stressors. Each module takes about 60 minutes per week for 6 weeks. Participation data will be collected from traffic source analysis performed using Google Analytics (http://www.google.com/analytics), an integral feature of Google.
Overview of curriculum
Module 1:
• Overview & introduction to the program
• Initial orientation to Mindfulness
• Coming home to the body and breath
• Interactive activities:
o Journaling feature, True or false quiz
Module 2:
• Developing Sense Awareness Initial orientation to Mindfulness
• Noticing our senses
• Interactive activities:
o Journaling feature, Mix and match sentences
Module 3:
• Developing Attention and Focus
• Moments of mindful noticing
• Interactive activities:
o Journaling feature, Fill in the gaps
Module 4:
• Present-Moment Awareness of Life Moments
• Being with both the good and the bad
• Interactive activities:
o Journaling feature, Make pairs/jumbled pairs
Module 5:
• Examining the Foundations of Stress
• Mindful breathing to reset the nervous system
• Interactive activities:
o Journaling feature, Odd one out quiz
Module 6:
• Cultivating Self-Care as a way to notice the good moments
• Self-kindness practice.
• Mindfulness for rest & sleep
• Interactive activities:
o Journaling feature, Mindful qualities /mix and match
Intervention code [1] 323432 0
Behaviour
Comparator / control treatment
Study participants will receive access to the web- based mindfulness modules on completion of the baseline survey and waitlist control group will receive access on completion of the post- survey (after 6 weeks).
Control group
Active

Outcomes
Primary outcome [1] 331160 0
Recruitment feasibility: Detailed tracking of recruitment processes, including number of targeted emails sent, number of views, retweets and shares
Timepoint [1] 331160 0
Data will be collected at the conclusion of the study- 6 weeks post-intervention commencement
Primary outcome [2] 332208 0
Retention and participation: Retention rate will be estimated by number of participants completing post-program measures. Participation data will be collected from traffic source analysis performed using Google Analytics
Timepoint [2] 332208 0
Data will be collected at the conclusion of the study- 6 weeks post-intervention commencement
Primary outcome [3] 332209 0
Participant satisfaction: Satisfaction survey consisting of five items, including ease of navigation, meaningfulness, usefulness in improving general well-being, ability to gain mindful awareness, and whether the web-based platform is challenging with a 4-point Likert-scale response ranging from agree completely to disagree with an option for open-ended response text on completion of 6 weeks after the pre test
Timepoint [3] 332209 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [1] 409046 0
Mindfulness: By using Mindful Attention Awareness Scales (MAAS)
Timepoint [1] 409046 0
Baseline and 6 weeks post-intervention commencement
Secondary outcome [2] 412546 0
Quality of life: by using Paediatric Quality of Life Cancer Module Scale-27 items
Timepoint [2] 412546 0
Baseline and 6 weeks post-intervention commencement
Secondary outcome [3] 412547 0
Depressive symptoms: By using Patient Health Questionnaire-2
Timepoint [3] 412547 0
Baseline and 6 weeks post-intervention commencement
Secondary outcome [4] 412548 0
Distress: By using Kessler Psychological Distress Scale
Timepoint [4] 412548 0
Baseline and 6 weeks post-intervention commencement

Eligibility
Key inclusion criteria
Young people aged 15-30 years diagnosed with cancer
Minimum age
15 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Young people from countries other than Australia or New Zealand

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
• Social media influence will be calculated using the ‘Klout Score’. Klout (Klout Inc, San Francisco, US) is a free online social media analytics tool used to rank users according to their online social influence by means of their proprietary Klout Score. This is a numerical value between 1 and 100, measured using access- and analysis related metrics from linked social media accounts in the preceding 90 days. These may include follower counts, retweets and the influence of the users who retweet your own messages.
• Frequencies will be used to examine the retention rate of post-test completion in study group and waitlist control group and google analytics data including time spent in each module and in activities.
• Paired t tests will be conducted to examine pre-post differences in the psychosocial outcomes of interest, and Cohen’s d effect sizes and confidence intervals will be calculated to examine the effect size of any changes in mindfulness, quality of life, stress and depressive symptoms.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2022
Actual
Date of last participant enrolment
Anticipated
1/09/2023
Actual
Date of last data collection
Anticipated
29/12/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24808 0
New Zealand
State/province [1] 24808 0

Funding & Sponsors
Funding source category [1] 311300 0
University
Name [1] 311300 0
Western Sydney University
Country [1] 311300 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 312958 0
Charities/Societies/Foundations
Name [1] 312958 0
Canteen
Address [1] 312958 0
75 King St, Newtown, NSW 2042
Country [1] 312958 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310802 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 310802 0
Locked Bag 1797
Penrith
NSW 2751
Ethics committee country [1] 310802 0
Australia
Date submitted for ethics approval [1] 310802 0
04/07/2022
Approval date [1] 310802 0
Ethics approval number [1] 310802 0

Summary
Brief summary
Young people who have been diagnosed with cancer may experience long term adverse effects on their emotional and mental wellbeing. This study aims to determine whether it is feasible to deliver an online age and cancer-specific mindfulness intervention, and to investigate the potential for this intervention to impact these patients' quality of life and wellbeing.
Who is it for?
You may be eligible for this study if you are aged between 15 and 30 years and you have been diagnosed with cancer.
Study details
Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either receive the intervention immediately, or to receive the intervention at the end of the study (waitlist group). Participants who are allocated to the immediate intervention group will be given access to the web-based mindfulness program by an email and participants in the waitlist group will receive access on completion of the post- survey (after 6 weeks). The online intervention will involve completion of one 60 minute module each week for 6 weeks. After the 6 weeks both groups will complete the post-test questionnaires of the same quantitative measures and in addition the immediate intervention group receives a post program survey with open-ended questions to assess the feasibility of the mindfulness program.
It is hoped this research will demonstrate whether it is possible to recruit and deliver a mindfulness-based intervention online. If the mindfulness program shows a positive impact on the quality of life and wellbeing of participants in this pilot study, a larger study enrolling a greater number of patients may go ahead and could lead to future benefits for more young cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118922 0
Dr Sheeja Perumbil Pathrose
Address 118922 0
c/o Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 118922 0
Australia
Phone 118922 0
+61424998479
Fax 118922 0
Email 118922 0
S.Pathrose@westernsydney.edu.au
Contact person for public queries
Name 118923 0
Dr Sheeja Perumbil Pathrose
Address 118923 0
c/o Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 118923 0
Australia
Phone 118923 0
+61 424998479
Fax 118923 0
Email 118923 0
S.Pathrose@westernsydney.edu.au
Contact person for scientific queries
Name 118924 0
Dr Sheeja Perumbil Pathrose
Address 118924 0
c/o Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 118924 0
Australia
Phone 118924 0
+61 424998479
Fax 118924 0
Email 118924 0
S.Pathrose@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect privacy and maintain anonymity


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16240Study protocol    383966-(Uploaded-01-08-2022-11-07-05)-Study-related document.docx
16242Informed consent form    383966-(Uploaded-01-08-2022-11-09-18)-Study-related document.docx



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.