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Trial registered on ANZCTR


Registration number
ACTRN12620000155998
Ethics application status
Approved
Date submitted
21/01/2020
Date registered
13/02/2020
Date last updated
10/07/2023
Date data sharing statement initially provided
13/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Community Implementation of the ‘Cascade’ (Cope, Adapt, Survive: life after CAncEr) online program for parents of child, adolescents and young adult (AYA) cancer survivors A Phase-III Trial.
Scientific title
Community Implementation of the ‘Cascade’ (Cope, Adapt, Survive: life after CAncEr) online program for parents of child, adolescents and young adult (AYA) cancer survivors A Phase-III Trial.
Secondary ID [1] 300308 0
Nil Known
Universal Trial Number (UTN)
U1111-1246-9350
Trial acronym
CASCADE
Linked study record
ACTRN12613000270718 is a parent study of the present study.

Health condition
Health condition(s) or problem(s) studied:
Paediatric Cancer 315911 0
Condition category
Condition code
Cancer 314182 314182 0 0
Any cancer
Mental Health 314183 314183 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"Cascade". This study is an implementation study, and therefore we may refer to the study as the "Cascade implementation study", and the clinical intervention portion of the study the "Cascade intervention"
No evidence based, equitable community-delivered programs exist to provide skills-based support for parents of children, adolescents and young adult (AYA) cancer survivors. The Cascade implementation study aims to build on research on theoretically grounded online interventions for parents of child and AYA cancer survivors by teaching adaptive cognitive-behavioural coping skills to promote resilience in early survivorship. Previous research indicates that the Cascade program is acceptable, feasible and clinically safe for parents, and suggest that the intervention may stabilize parents’ fear of cancer recurrence. Also, similar previous online interventions have demonstrated that the online format is an acceptable way to deliver group-based interventions to members of rural and remote families in Australia.
The current project – the Cascade implementation study - has dual aims:
(1) To evaluate the clinical effectiveness of the Cascade program in providing an avenue for peer support and teaching CBT and coping skills among parents of child and AYA cancer survivors (aged up to 25 years) when delivered in a community setting.
(2) To evaluate the implementation of the Cascade program in community cancer support setting(s). Factors including intervention fidelity, participant recruitment and retention, reach/organizational uptake, and financial sustainability will be assessed.
The Cascade program is designed to be easily integrated into programs already offered by community organisations, and to be easily accessible to both metropolitan and rural families in Australia.
Regarding study materials, parent participants will receive a written manual summarising the weekly home practice activities. Intervention providers (also treated as participants – henceforth “facilitators”) will participate in several workshops that instruct on how to deliver the Cascade intervention to parents over online videoconferencing software. Additionally, facilitator participants will receive a manual covering in detail how to deliver each module of the Cascade intervention.
The process of implementation of the Cascade intervention at any given community organisation can be outlined as a series of stages. Over the course of the Cascade implementations study, we expect to work with several community organisations, and it may therefore be the case that different organisations will be at different stages of implementation at any one time. See below for a stage-wise breakdown of the Cascade implementation study:
a. Planning and consultation – The lead study team will consult with management staff at each community organisation to organise infrastructure, personnel, training, and advertising of the Cascade intervention
b. Advertising and recruitment – The Cascade intervention will be advertised to our target consumer base on social media platforms. Also, referrals may be received from counselling staff within the community organisation and staff from other relevant clinical services around Australia
c. Consent – Informed consent will be obtained from all participants via Qualtrics
d. Intake – Parent participants will complete a brief telephone intake call to confirm eligibility, obtain consumer details, assess risk, and obtain the details of a trusted healthcare professional and of another support-person. Parents complete a baseline questionnaire (Q1) and receive a written manual of Cascade session content at roughly this time.
e. Introductory session – After group allocation, parent participants will complete a one-on-one online session with the group facilitator to troubleshoot technical issues, allow the facilitator to build rapport, and provide opportunity for the parent participant to set personalised goals for the program. This will take approximately 20 minutes.
f. Treatment - Following the introductory session, parents will complete four weekly online group sessions, with each focussing on a specific module. Modules are ordered as following: psychoeducation and health (behavioural activation); appraisal (unhelpful thinking styles); mindfulness and disengagement; social support (assertiveness). Each 90-minute module focusses on applying CBT techniques to areas of concern specific to parents of child and AYA cancer survivors. Tailored supportive counselling is used in all Cascade sessions, and empathic listening is used to normalise the range of parent experiences and promote peer discussion/support. Home practice is encouraged for parent participants, with practice exercises and examples in the provided manual.
g. Booster session - One week after the end of Module 4, parent participants will complete a one-on-one booster session with their group facilitator to review and consolidate skills learnt across the program, receive additional input from the facilitator, and discuss how to apply these skills to new challenges that may have arisen since finishing their program. The facilitator will also follow up with the goal outlined by the parent participant in the initial introduction session. Participants will complete a second questionnaire (Q2) one to four weeks after completion of the booster session. The booster session will take 10-60 minutes.
Intervention providers for Cascade will be community organisation staff members trained in the delivery of Cascade. Intervention training will consist of 2x half-day workshops and be comprised of experiential and adaptation sessions. Training sessions will take place during planning and consultation with community organisations – approximately 3 months prior to intervention commencement. Facilitators will be registered healthcare professionals (including but not limited to psychologists, clinical psychologists, counsellors, and nurses), or students completing clinical training under supervision of a registered healthcare professional.
The Cascade intervention will be delivered to parent participants via online videoconferencing. This will involve third-party videoconferencing clients (e.g. Zoom, WebEx, etc.) The Cascade intervention is designed to be delivered as a group intervention, with module content tailored around shared engagement. Only the Introductory session and Booster session will be delivered as a one-on-one session between the facilitator and parent participant.
As the Cascade intervention is designed to be delivered online in a group videoconferencing format – therefore infrastructure requirements are minimal. Facilitators will make use of remote counselling tools made available by their community organisations. Parent participants will require access to a computer/tablet/mobile with a webcam and microphone and will need a quiet and private space in which to participate in online videocalls for the four-week period of the Cascade intervention. This private space is expected to be in the parent participants’ home but can practically be anywhere that is private and quiet.
Given the spontaneous nature of group interventions, facilitators will be expected to adapt the program on the fly, if their clinical judgement deems that certain aspects of the program require more or less emphasis than stated in the manual. Facilitators will adapt the program while delivering the Cascade group modules. Additionally, prior to group sessions, parent participants will be given the opportunity to provide their own goals and expectations for the program. Facilitators are expected to utilise their clinical experience and judgement to modify the content of the group modules as they see fit. Details on how program adaptation will be recorded are provided below.
Cascade is designed as a hybrid implementation-effectiveness study. Assessment of program fidelity is a critical part of this research. Facilitators will collect data in the form of process notes. Facilitators will be provided with a template for each session, where they will note the extent to which each topic was covered, the level of parent participant engagement, and if any technical or other issues occurred which were an obstacle to running through the intervention.
Intervention code [1] 316586 0
Behaviour
Intervention code [2] 316715 0
Treatment: Other
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322564 0
Emotion regulation, as measured by the Emotion Regulation Questionnaire
Timepoint [1] 322564 0
6 weeks after completion of a baseline questionnaire
Secondary outcome [1] 378954 0
Self-reported coping behaviours, as measured by the Brief COPE.
Timepoint [1] 378954 0
6 weeks afer completion of a baseline questionnaire.
Secondary outcome [2] 379432 0
Intention to perform coping behaviours, as measured by the Coping Self-Efficacy Scale.
Timepoint [2] 379432 0
6 weeks after completion of a baseline questionnaire.
Secondary outcome [3] 379433 0
Feelings of peer support, as measured by the Modified Cancer Peer Support Scale.
Timepoint [3] 379433 0
6 weeks after completion of a baseline questionnaire.
Secondary outcome [4] 379434 0
Psychological distress, as mesaured by the Kessler Psychological Distress Scale.
Timepoint [4] 379434 0
6 weeks after completion of a baseline questionnaire.
Secondary outcome [5] 379435 0
Self-reported emotional distress, anxiety, depression, anger, and need for help, as measured by Emotion Thermometers. This measure is a composite measure.
Timepoint [5] 379435 0
6 weeks after completion of a baseline questionnaire.
Secondary outcome [6] 379436 0
Cognitive-behavioural therapy skills acquisition and use, as assessed by a purposively designed 10-item questionnaire item.
Timepoint [6] 379436 0
6 weeks after completion of a baseline questionnaire.
Secondary outcome [7] 379437 0
Percieved program benefit/burden, as assessed by two purposively-developed items.
Timepoint [7] 379437 0
6 weeks after completion of a baseline questionnaire.
Secondary outcome [8] 379438 0
Participants' therapeutic alliance with their online facilitator, as measured by the Working Alliance Inventory - Short Revised.
Timepoint [8] 379438 0
One week after intervention completion.
Secondary outcome [9] 379441 0
General change in health/mental health status over the course of the intervention, assessed by participant self-report.. This measure is a composite measure.
Timepoint [9] 379441 0
One week after intervention completion.
Secondary outcome [10] 379447 0
Impact of training/program delivery on community counselling staff, as assessed by a brief questionnaire, and structured interview on community organisation staff involved in implementing Cascade. Note: this is part of the evaluation of program implementation.
Timepoint [10] 379447 0
Interviews will be conducted at three timepoints during the intervention's implementation at any community organisation:
1 - Prior to intervention delivery, and during consultation between the lead study group and the community organisation.
2 - As the program is being implemented at the community organisation - while the community organisation is actively recruiting and delivering the intervention to participants.
3 - After the completion of program implementation at the community organisation - after all planned groups have recieved the implementation.
Secondary outcome [11] 379449 0
Participant responsiveness, as measured by descriptive statistics on program uptake rates, session attendance, and attrition rates. Note: this is part of the evaluation of program implementation.
Timepoint [11] 379449 0
After all participants have completed the Cascade intervention, and data analysis has commenced.
Secondary outcome [12] 379450 0
Technical issues, as recorded by session logs completed by community organisation staff.
Timepoint [12] 379450 0
This data will be recorded during each Cascade session, and analysed once all participants have completed the Cascade intervention.
Secondary outcome [13] 379453 0
Intervention fidelity, as recorded in session logs completed by community organisation staff.
Timepoint [13] 379453 0
This data will be recorded during each Cascade session, and analysed once all participants have completed the Cascade intervention.
Secondary outcome [14] 379456 0
Financial sustainability, as assessed by an economic analysis of time and resource costs to the lead Cascade study team and partnering community organisations.
Timepoint [14] 379456 0
After all participants have completed the Cascade intervention, and data analysis has commenced.

Eligibility
Key inclusion criteria
For parent participants:
Eligible participants must be able to:
• Give informed consent;
• Read English;
• Provide the name and contact details of a trusted health professional, such as their local general practitioner;
• Have access to a computer/laptop/tablet with a webcam and microphone;
• Access the Internet in a private location (that is, where they will feel comfortable discussing issues related to their child’s cancer) once a week for 4 weeks to be able to participate in the intervention.

For facilitators:
Community organisation staff members will be eligible to participate (i.e. be trained in and evaluate Cascade) if they:
• Are a registered healthcare professional (including but not limited to psychologists, clinical psychologists, and nurses); and/OR
• Have prior experience in the delivery of a cognitive-behaviour therapy group treatment program; and/OR
• Are determined by the community organisation as having sufficient experience to deliver the program; and/OR
• Are a doctoral or masters student completing clinical training under the supervision of a registered health professional.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For parent participants:
Exclusion criteria include:
• Any parent of a child who is in palliative care.
• Any parent with severe depression and/or suicidal intent or plan, as determined in the initial intake interview or by the participant’s responses to the first questionnaire. Participants who report at the initial intake interview that they are currently experiencing serious suicidal intent (with or without a defined plan) will be excluded with appropriate referral options provided. Further, parents scoring = 30 on the Kessler Psychological Distress Scale (K10) will be telephoned and assessed further to determine whether or not their score is indicative of a ‘severe’ mental health disorder and to assess suicidal risk (See Appendix 1 for guidelines on suicide risk assessment). In the case where a parent is experiencing a ‘severe’ mental health disorder and/or suicidal risk they will be excluded and provided with appropriate referral options.
• Any parent who reports that they are currently undergoing treatment for Schizophrenia, or who is judged to be currently experiencing a psychotic episode, based on clinical judgment at the initial interview (see initial intake interview schedule Appendix 1).
• Any parent reporting substance abuse.

For facilitators:
Staff will be ineligible to be trained to deliver Cascade if they are:
• Not a registered healthcare professional; AND
• Have insufficient experience with the delivery of cognitive-behavioural therapy interventions.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The total target sample size is N=69 parents of child and AYA cancer survivors over our recruitment period.

We will use the Emotion Regulation Questionnaire (ERQ) as a measure of our primary therapeutic outcome – parent use of emotion regulation strategies. The ERQ is a well-established measure consisting of questions that test two independent factors; reappraisal and suppression. Both factors have an estimated test-retest reliability of r=0.69 across 3 months.

Although the time between Q1 and Q2 of the Cascade is likely to be 1.5 months as opposed to 3 months, we have elected to use r=0.69 as a conservative estimate of the within-individual correlation over the shorter time period. Using a paired t-test with a two-sided significance level of 0.025 separately for each emotion regulation factor, a sample size of N=69 provides >80% power to detect a small change (d=0.3) over the time of the Cascade intervention. The significance level of 0.025 for each test controls the overall type I error rate associated with performing statistical comparisons on the two independent measures at 5%.

We estimate that N=20 community staff from community partner sites will be trained to deliver the Cascade program over the whole trial.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
29/09/2021
Actual
20/08/2021
Date of last participant enrolment
Anticipated
30/12/2022
Actual
3/10/2022
Date of last data collection
Anticipated
10/02/2023
Actual
19/12/2022
Sample size
Target
69
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 22242 0
New Zealand
State/province [1] 22242 0
Country [2] 22295 0
Mexico
State/province [2] 22295 0
Country [3] 22296 0
United Kingdom
State/province [3] 22296 0

Funding & Sponsors
Funding source category [1] 304728 0
Charities/Societies/Foundations
Name [1] 304728 0
Cancer Council
Country [1] 304728 0
Australia
Primary sponsor type
University
Name
Behavioural Sciences Unit, UNSW Sydney
Address
The Behavioural Sciences Unit, Kids Cancer Centre
Sydney Children's Hospital, Level 1
High St, Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 305063 0
None
Name [1] 305063 0
N/A
Address [1] 305063 0
N/A
Country [1] 305063 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305153 0
UNSW HREC
Ethics committee address [1] 305153 0
Ethics committee country [1] 305153 0
Australia
Date submitted for ethics approval [1] 305153 0
12/11/2019
Approval date [1] 305153 0
31/01/2020
Ethics approval number [1] 305153 0
HC190880

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

Contacts
Principal investigator
Name 99418 0
Dr Lauren Kelada
Address 99418 0
Behavioural Sciences Unit, Kids Cancer Centre, Sydney Children's Hospital

School of Women's and Children's Health, UNSW Sydney, Australia
Country 99418 0
Australia
Phone 99418 0
+61 02 9382 1789
Fax 99418 0
+61 02 9382 1789
Email 99418 0
l.kelada@unsw.edu.au
Contact person for public queries
Name 99419 0
Lauren Kelada
Address 99419 0
Behavioural Sciences Unit, Kids Cancer Centre, Sydney Children's Hospital

School of Women's and Children's Health, UNSW Sydney, Australia
Country 99419 0
Australia
Phone 99419 0
+61 02 9382 1789
Fax 99419 0
+61 02 9382 1789
Email 99419 0
l.kelada@unsw.edu.au
Contact person for scientific queries
Name 99420 0
Lauren Kelada
Address 99420 0
Behavioural Sciences Unit, Kids Cancer Centre, Sydney Children's Hospital

School of Women's and Children's Health, UNSW Sydney, Australia
Country 99420 0
Australia
Phone 99420 0
+61 02 9382 1789
Fax 99420 0
+61 02 9382 1789
Email 99420 0
l.kelada@unsw.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6583Study protocol    379090-(Uploaded-03-02-2020-14-06-58)-Study-related document.docx
6588Informed consent form    379090-(Uploaded-03-02-2020-14-08-50)-Study-related document.docx
6902Ethical approval    379090-(Uploaded-13-02-2020-13-40-18)-Study-related document.Pdf



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.