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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.
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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.
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Secondary ID [1]
280649
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Nil
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Universal Trial Number (UTN)
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Trial acronym
"Cascade": A parent/carer-targeted intervention to improve quality of life in families of young cancer survivors.
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Quality of life
287007
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Distress
287008
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Psychological adjustment
287009
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Condition category
Condition code
Mental Health
286962
286962
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0
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Anxiety
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Mental Health
286963
286963
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0
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Depression
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Cancer
286964
286964
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0
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Any cancer
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
285050
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Behaviour
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Intervention code [2]
285051
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Treatment: Other
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Intervention code [3]
285052
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Prevention
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Quality of Life is the primary outcome as measured by the cancer-specific Quality of Life-Family Scale (QoL-Family; Ferrell, 1999).
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Assessment method [1]
287303
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Timepoint [1]
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Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
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Secondary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
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Secondary outcome [2]
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Family interactions and communication will be measured using the PedsQL-Family impact module (Varni et al., 2004)
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Assessment method [2]
297866
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Timepoint [2]
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Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
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Secondary outcome [3]
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Satisfaction with parenting and self-efficacy in the parenting role will be assessed by the Parent Self-Agency Measure (Revised) (Dumka et al., 2006).
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Assessment method [3]
297867
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Timepoint [3]
297867
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Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
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Secondary outcome [4]
297868
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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).
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Assessment method [4]
297868
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Timepoint [4]
297868
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Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
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Secondary outcome [5]
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To assess child's wellbeing by proxy, parents/carers will complete PedsQL-generic core modules (Varni et al., 2002).
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Assessment method [5]
297869
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Timepoint [5]
297869
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Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
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Secondary outcome [6]
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To build participant engagement and increase clinical relevance, parents will complete the Psychosocial Adjustment to Illness Scale Clinical Interview-Carer version (PAIS; Derogatis, 1986).
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Assessment method [6]
297870
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Timepoint [6]
297870
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Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
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Secondary outcome [7]
306972
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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).
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Assessment method [7]
306972
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Timepoint [7]
306972
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Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
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Secondary outcome [8]
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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
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Assessment method [8]
306973
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Timepoint [8]
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Pretreatment, 1-week post intervention, 5 weeks post intervention and 6 months post intervention
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Secondary outcome [9]
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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).
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Assessment method [9]
306974
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Timepoint [9]
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1-week post intervention, 5 weeks post intervention and 6 months post intervention
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Secondary outcome [10]
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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
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Assessment method [10]
306975
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Timepoint [10]
306975
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1-week post intervention, 5 weeks post intervention and 6 months post intervention
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/03/2014
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Actual
27/08/2014
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Date of last participant enrolment
Anticipated
31/05/2017
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Actual
15/11/2017
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Date of last data collection
Anticipated
31/07/2018
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Actual
30/11/2018
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Sample size
Target
120
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Accrual to date
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Final
76
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
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Recruitment hospital [1]
2120
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Sydney Children's Hospital - Randwick
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Recruitment hospital [2]
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The Children's Hospital at Westmead - Westmead
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Recruitment hospital [3]
2122
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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Womens and Childrens Hospital - North Adelaide
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Recruitment hospital [5]
2124
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The Royal Childrens Hospital - Parkville
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Recruitment hospital [6]
2125
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Royal Children's Hospital - Herston
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Recruitment hospital [7]
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Princess Margaret Hospital - Subiaco
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Recruitment hospital [8]
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Monash Medical Centre - Clayton campus - Clayton
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Funding & Sponsors
Funding source category [1]
285415
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Hospital
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Name [1]
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Kids Cancer Centre
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Address [1]
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Level 1, South Wing,
Sydney Children's Hospital,
High Street,
Randwick, Sydney, 2031,
NSW
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Country [1]
285415
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Australia
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Funding source category [2]
288774
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Government body
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Name [2]
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Cancer Australia
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Address [2]
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Level 14, 300 Elizabeth St, Surry Hills NSW 2010
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Country [2]
288774
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Australia
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Funding source category [3]
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Charities/Societies/Foundations
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Name [3]
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Cancer Council NSW Program Grant with the support of the Estate of Late Harry McPaul.
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Address [3]
296246
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153 Dowling St, Woolloomooloo NSW 2011
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Country [3]
296246
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Australia
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Primary sponsor type
University
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Name
University of New South Wales
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Address
School of Women’s and Children’s Health,
University of New South Wales,
Anzac Parade,
Kensington, Sydney, 2052,
NSW
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Sydney Children's Hospital
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Address [1]
284266
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Kids Cancer Centre,
Level 1, South Wing,
Sydney Children's Hospital,
High Street,
Randwick, Sydney, 2031,
NSW
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Country [1]
284266
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
287428
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
287428
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Research Ethics and Governance Unit District Headquarters, Administration Building Lookout Road, New Lambton NSW 2305
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Ethics committee country [1]
287428
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Australia
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Date submitted for ethics approval [1]
287428
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31/01/2014
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Approval date [1]
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20/02/2014
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Ethics approval number [1]
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HREC/14/HNE/44
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Summary
Brief summary
This study looks at the effectiveness of a psychological therapy designed to support parents and carers of children and young people with cancer to make a positive transition to life after treatment completion. Who is it for? You can join this study if you are the parent of a young cancer survivor aged under 18 years who has finished treatment for either a primary or secondary cancer. Trial details: Participants will be divided into three groups. One group will take part in 'Cascade', a cognitive-behavioural program designed to help people build skills to return to normality after cancer treatment. This will take place in four 90-minute group sessions, delivered weekly over the internet. The second group will take part in an open discussion forum with the same schedule. The third group will be allocated to a waitlist before participating in one of the interventions. The study aims to monitor the distress, psychological adjustment and coping after cancer treatment. Participants complete several questionnaires and will be followed up for 6 months after participating in the online groups.
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Trial website
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Trial related presentations / publications
Wakefield, C.E., Sansom-Daly, U. M., McGill, B.C., Ellis, S.J., Doolan, E.L., Robertson, E.G., Mathur, S., Cohn, R.J. (2016). Acceptability and feasibility of an e-mental health intervention for parents of childhood cancer survivors: ‘Cascade’. Supportive Care in Cancer, 24(6):2685-94. doi: 10.1007/s00520-016-3077-6. Wakefield, C.E., Sansom-Daly, U.M., McGill, B.C., McCarthy, M., Girgis, A., Grootenhuis, M., Barton, B., Patterson, P., Osborn, M., Lowe, C., Anazodo, A., Miles, G., Cohn, R.J. (2015). Online parent-targeted cognitive-behavioural therapy intervention to improve quality of life in families of young cancer survivors: study protocol for a randomised controlled trial. Trials, 16: 153-165. Ellis, S.J., Wakefield, C.E., Sansom-Daly, U.M., McGill, B.C., Robertson, E.G., Marshall, K., Hetherington, K., Doolan, E.L., and Cohn, R.J. (2016). Evaluation of ‘Cascade’: online support for parents following their child’s cancer treatment. Sydney Cancer Conference, 23rd Sept 2016. McGill, B.C., Wakefield, C.E., Sansom-Daly, U.M., Hetherington, K., Ellis, S.E., Marshall, K.H., Robertson, E.G., Doolan, E.L., and Cohn, R.J (2015). When it doesn’t end at ‘cure’: online cognitive-behavioural therapy (CBT) to support parents after their child’s cancer treatment. Oral presentation at the World Congress of Behavioural and Cognitive Therapies, 25th June 2016, Melbourne, Australia. Wakefield, C.E., Sansom-Daly, U.M., McGill, B., Robertson, E., Doolan, E.L., & Cohn, R. J. Cascade: A randomised trial of an online psychological intervention for parents after their child’s cancer treatment. Abstract accepted for oral presentation at the Australian Psychological Society College of Health Psychologists Annual Conference as part of a symposium entitled, ‘Promoting adaptive health behaviours in at-risk groups in paediatric/adolescent oncology’, 10-11 April 2015, Coogee, Australia. Wakefield, C.E. A new e-mental health intervention for parents of childhood cancer survivors: CASCADE. Australian New Zealand Children’s Haematology and Oncology Group (ANZCHOG), Annual Scientific Meeting, Sydney, 2014.
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Public notes
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Contacts
Principal investigator
Name
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Dr Claire Wakefield
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Address
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Kids Cancer Centre,
Level 1 South, Sydney Children's Hospital, High Street
Randwick NSW 2031
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Country
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Australia
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Phone
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(+612) 9382 3113
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Claire Wakefield
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Address
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Kids Cancer Centre,
Level 1 South Wing
Sydney Children's Hospital
High Street
Randwick NSW 2031
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Country
17540
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Australia
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Phone
17540
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(+612) 9382 3113
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Fax
17540
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Email
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[email protected]
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Contact person for scientific queries
Name
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Claire Wakefield
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Address
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Kids Cancer Centre,
Level 1 South Wing
Sydney Children's Hospital
High Street
Randwick NSW 2031
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Country
8468
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Australia
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Phone
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(+612) 9382 3113
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Fax
8468
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
1765
Study 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
Source
Title
Year of Publication
DOI
Embase
Online parent-targeted cognitive-behavioural therapy intervention to improve quality of life in families of young cancer survivors: Study protocol for a randomised controlled trial.
2015
https://dx.doi.org/10.1186/s13063-015-0681-6
Embase
Acceptability and feasibility of an e-mental health intervention for parents of childhood cancer survivors: "Cascade".
2016
https://dx.doi.org/10.1007/s00520-016-3077-6
Embase
Providing psychological support to parents of childhood cancer survivors: 'cascade' intervention trial results and lessons for the future.
2021
https://dx.doi.org/10.3390/cancers13225597
N.B. These documents automatically identified may not have been verified by the study sponsor.
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