ANZCTR - Registration

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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer

Condition category

Condition code

Cancer

Any cancer

Mental Health

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]

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]

Recruitment feasibility: Detailed tracking of recruitment processes, including number of targeted emails sent, number of views, retweets and shares

Timepoint [1]

Data will be collected at the conclusion of the study- 6 weeks post-intervention commencement

Primary outcome [2]

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]

Data will be collected at the conclusion of the study- 6 weeks post-intervention commencement

Primary outcome [3]

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]

Cumulative data will be assessed at the conclusion of the study

Secondary outcome [1]

Mindfulness: By using Mindful Attention Awareness Scales (MAAS)

Timepoint [1]

Baseline and 6 weeks post-intervention commencement

Secondary outcome [2]

Quality of life: by using Paediatric Quality of Life Cancer Module Scale-27 items

Timepoint [2]

Baseline and 6 weeks post-intervention commencement

Secondary outcome [3]

Depressive symptoms: By using Patient Health Questionnaire-2

Timepoint [3]

Baseline and 6 weeks post-intervention commencement

Secondary outcome [4]

Distress: By using Kessler Psychological Distress Scale

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Western Sydney University

Address [1]

Western Sydney University
Locked Bag 1797
Penrith NSW 2751

Country [1]

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]

Charities/Societies/Foundations

Name [1]

Canteen

Address [1]

75 King St, Newtown, NSW 2042

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Western Sydney University Human Research Ethics Committee

Ethics committee address [1]

Locked Bag 1797
Penrith
NSW 2751

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/07/2022

Approval date [1]

Ethics approval number [1]

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

Dr Sheeja Perumbil Pathrose

Address

c/o Western Sydney University
Locked Bag 1797
Penrith
NSW 2751

Country

Australia

Phone

+61424998479

Fax

S.Pathrose@westernsydney.edu.au

Contact person for public queries

Name

Sheeja Perumbil Pathrose

Address

c/o Western Sydney University
Locked Bag 1797
Penrith
NSW 2751

Country

Australia

Phone

+61 424998479

Fax

S.Pathrose@westernsydney.edu.au

Contact person for scientific queries

Name

Sheeja Perumbil Pathrose

Address

c/o Western Sydney University
Locked Bag 1797
Penrith
NSW 2751

Country

Australia

Phone

+61 424998479

Fax

S.Pathrose@westernsydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

To protect privacy and maintain anonymity

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16240	Study protocol					383966-(Uploaded-01-08-2022-11-07-05)-Study-related document.docx
16242	Informed 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.

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