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Trial registered on ANZCTR


Registration number
ACTRN12613000270718
Ethics application status
Approved
Date submitted
8/06/2012
Date registered
6/03/2013
Date last updated
1/04/2019
Date data sharing statement initially provided
1/04/2019
Date results provided
1/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A multicentre phase II randomised controlled trial of a parent/carer-targeted intervention to improve quality of life in families of young cancer survivors.
Scientific title
A multicentre phase II randomised controlled trial of a parent/carer-targeted intervention to improve quality of life in families of young cancer survivors.
Secondary ID [1] 280649 0
Nil
Universal Trial Number (UTN)
Trial acronym
"Cascade": A parent/carer-targeted intervention to improve quality of life in families of young cancer survivors.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of life 287007 0
Distress 287008 0
Psychological adjustment 287009 0
Condition category
Condition code
Mental Health 286962 286962 0 0
Anxiety
Mental Health 286963 286963 0 0
Depression
Cancer 286964 286964 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 3 arms to this trial. Arm 1: 'Cascade', a cognitive-behavioural intervention. Arm 2: Peer Support Group (PSG) who will receive supportive counselling. Arm 3: will be randomised to a 6-month waitlist until the post-intervention assessments of the other groups are complete, at which point they will be randomly allocated to one of the other two arms. 'Cascade' will be delivered in 4 x 90-minute group sessions, delivered weekly over the internet using web-conferencing technology by a clinical psychologist. These sessions will focus on the acquisition and application of cognitive-behavioural skills, such as cognitive restructuring and problem-solving, and the experience of returning to normality post cancer treatment. Participants in the Cascade and PSG arms will receive a one hour, online booster session with the same facilitator who delivered their intervention. The intervention will be offered to parents and carers of children aged under 18 years who are post active treatment. For adolescents and young adults (AYAs) aged 15-25 years 1-12 months post active treatment is registered here http://www.anzctr.org.au/ACTRN12610000717055.aspx
Intervention code [1] 285050 0
Behaviour
Intervention code [2] 285051 0
Treatment: Other
Intervention code [3] 285052 0
Prevention
Comparator / control treatment
The Peer Support group condition uses the same group format, delivered over the internet by a clinical psychologist for four, weekly, 90 minute sessions. This therapy includes nondirective supportive counselling that does not include any Cognitive Behaviour Therapy components, but will instead simply give parents and carers of young cancer survivors an open forum to discuss their experience, similar to that offered in facilitated peer support groups. The intervention will be offered to parents and carers of children aged under 18 years who have completed active cancer treatment. Participants randomised to both Cascade and the Peer Support Group condition will receive a one hour, online booster session with the same facilitator who delivered their intervention.
Control group
Active

Outcomes
Primary outcome [1] 287303 0
Quality of Life is the primary outcome as measured by the cancer-specific Quality of Life-Family Scale (QoL-Family; Ferrell, 1999).
Timepoint [1] 287303 0
Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
Secondary outcome [1] 297865 0
Parent Mental Health will be assessed by items measuring depression and anxiety. These items will be administered online through the KeySurvey using the PROMIS short-form measures
Timepoint [1] 297865 0
Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
Secondary outcome [2] 297866 0
Family interactions and communication will be measured using the PedsQL-Family impact module (Varni et al., 2004)
Timepoint [2] 297866 0
Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
Secondary outcome [3] 297867 0
Satisfaction with parenting and self-efficacy in the parenting role will be assessed by the Parent Self-Agency Measure (Revised) (Dumka et al., 2006).
Timepoint [3] 297867 0
Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
Secondary outcome [4] 297868 0
To assess child's wellbeing by proxy, parents/carers will complete PedsQL-generic core modules (Varni et al., 2002), incorporating the child's physical, emotional, social and school functioning (where relevant).
Timepoint [4] 297868 0
Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
Secondary outcome [5] 297869 0
To assess child's wellbeing by proxy, parents/carers will complete PedsQL-generic core modules (Varni et al., 2002).
Timepoint [5] 297869 0
Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
Secondary outcome [6] 297870 0
To build participant engagement and increase clinical relevance, parents will complete the Psychosocial Adjustment to Illness Scale Clinical Interview-Carer version (PAIS; Derogatis, 1986).
Timepoint [6] 297870 0
Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
Secondary outcome [7] 306972 0
Medical care and general functioning in past six weeks (cost-consequence items)will be assessed by five purposely-designed items to assess participants’ level of health/psychosocial service use, medication use, time taken away from regular activities (e.g., study, work), and days spent engaging in regular activities (e.g., study, work).
Timepoint [7] 306972 0
Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
Secondary outcome [8] 306973 0
The centrality of their child's cancer to their identity will be assessed using Centrality of Events Scale (Berntsena and Rubin 2006): A 7-item measure
Timepoint [8] 306973 0
Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
Secondary outcome [9] 306974 0
Cognitive-behavioural therapy skills acquisition and use: We have included 10 purposely designed items that assess participants’ self-efficacy using a number of cognitive and/or behavioural coping skills (yes/no), and the extent to which they have used these skills since finishing their online group (not at all/a little/a lot).
Timepoint [9] 306974 0
1-week post intervention, 5 weeks post intervention and 6 months post intervention
Secondary outcome [10] 306975 0
Intervention satisfaction: We have included a satisfaction Questionnaire (Reynolds et al. 2005) to assess satisfaction/acceptability of the intervention including requesting specific ratings of each module
Timepoint [10] 306975 0
1-week post intervention, 5 weeks post intervention and 6 months post intervention

Eligibility
Key inclusion criteria
Eligible participants will be parents/carers of children who are <18 years old and have finished cancer treatment with curative intent. Parents will be (1) Fluent in English; (2) Able to access the internet; (3) Not at risk of self-harm/psychosis (assessed during the initial clinical screen). Only one parent/carer from each family will be eligible to minimise clinical/logistical challenges. Parents of children who have previously relapsed (and are finished treatment with curative intent) will be eligible. However, if a child relapses or dies during the study, their parents will be referred to individual support.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals may not participate if they
(1) cannot speak English;
(2) exhibit suicidal intent, psychotic features, or substance dependence;
(3) their child is receiving active treatment, or palliative care. This includes if a child has recently relapsed and is still in active treatment; they and their family will be excluded, as their needs will be difficult to manage within the protocol, and their inclusion might also negatively affect others in their group.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential parents/carers will be sent a personalised invitation letter, consent form and opt-in card by their oncologist. The study coordinator will contact all parents who opt in to the study to conduct a brief validated screen related to self-harm and psychosis risk and request that they sign a written contract agreeing to use the provided equipment solely for the study and to address internet access issues (e.g. extending existing internet contracts/increasing download limits, claiming cost reimbursement). Participants will be randomly allocated to either Cascade, a peer support group, or a wait-list condition using an electronic randomiser implemented by independent personnel. Group allocation will occur at an off-site location, thus ensuring allocation concealment during the process of determining participant eligibility. Participants will be blinded to their intervention assignment, as both arms of the trial will be referred to as a 'peer support and education group for parents of young cancer survivors off-treatment'. This study will be managed in ‘blocks’ of 12 weeks, whereby participants are invited in groups, and managed through the program together. Participants will be sent a hired (insured) laptop two weeks before commencement of their group. This process will ensure equity (all participants receive identical equipment), minimise technical challenges (required software is pre-installed) and maximise security (security settings are pre-set by the technical support person). All equipment will be returned after study participation. Participants allocated to each of the three arms will complete their questionnaires on the same time schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using an electronic randomiser (using a random number system) implemented by independent personnel located at a distant site from the primary researchers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2014
Actual
27/08/2014
Date of last participant enrolment
Anticipated
31/05/2017
Actual
15/11/2017
Date of last data collection
Anticipated
31/07/2018
Actual
30/11/2018
Sample size
Target
120
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 2120 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 2121 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 2122 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 2123 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [5] 2124 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [6] 2125 0
Royal Children's Hospital - Herston
Recruitment hospital [7] 2126 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [8] 3647 0
Monash Medical Centre - Clayton campus - Clayton

Funding & Sponsors
Funding source category [1] 285415 0
Hospital
Name [1] 285415 0
Kids Cancer Centre
Country [1] 285415 0
Australia
Funding source category [2] 288774 0
Government body
Name [2] 288774 0
Cancer Australia
Country [2] 288774 0
Australia
Funding source category [3] 296246 0
Charities/Societies/Foundations
Name [3] 296246 0
Cancer Council NSW Program Grant with the support of the Estate of Late Harry McPaul.
Country [3] 296246 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Women’s and Children’s Health,
University of New South Wales,
Anzac Parade,
Kensington, Sydney, 2052,
NSW
Country
Australia
Secondary sponsor category [1] 284266 0
Hospital
Name [1] 284266 0
Sydney Children's Hospital
Address [1] 284266 0
Kids Cancer Centre,
Level 1, South Wing,
Sydney Children's Hospital,
High Street,
Randwick, Sydney, 2031,
NSW
Country [1] 284266 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287428 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 287428 0
Ethics committee country [1] 287428 0
Australia
Date submitted for ethics approval [1] 287428 0
31/01/2014
Approval date [1] 287428 0
20/02/2014
Ethics approval number [1] 287428 0
HREC/14/HNE/44

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

Contacts
Principal investigator
Name 34293 0
Dr Claire Wakefield
Address 34293 0
Kids Cancer Centre,
Level 1 South, Sydney Children's Hospital, High Street
Randwick NSW 2031
Country 34293 0
Australia
Phone 34293 0
(+612) 9382 3113
Fax 34293 0
Email 34293 0
[email protected]
Contact person for public queries
Name 17540 0
Claire Wakefield
Address 17540 0
Kids Cancer Centre,
Level 1 South Wing
Sydney Children's Hospital
High Street
Randwick NSW 2031
Country 17540 0
Australia
Phone 17540 0
(+612) 9382 3113
Fax 17540 0
Email 17540 0
[email protected]
Contact person for scientific queries
Name 8468 0
Claire Wakefield
Address 8468 0
Kids Cancer Centre,
Level 1 South Wing
Sydney Children's Hospital
High Street
Randwick NSW 2031
Country 8468 0
Australia
Phone 8468 0
(+612) 9382 3113
Fax 8468 0
Email 8468 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
All data collected will be de-identified for dissemination. There is no plan to make IPD available publicly. Only the research officers can access original data (in password protected files) for the purposes of data analysis and de-identification for publication/dissemination.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1765Study protocol    362615-(Uploaded-01-04-2019-10-16-21)-Study-related document.doc



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOnline parent-targeted cognitive-behavioural therapy intervention to improve quality of life in families of young cancer survivors: Study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s13063-015-0681-6
EmbaseAcceptability and feasibility of an e-mental health intervention for parents of childhood cancer survivors: "Cascade".2016https://dx.doi.org/10.1007/s00520-016-3077-6
EmbaseProviding psychological support to parents of childhood cancer survivors: 'cascade' intervention trial results and lessons for the future.2021https://dx.doi.org/10.3390/cancers13225597
N.B. These documents automatically identified may not have been verified by the study sponsor.