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Trial registered on ANZCTR


Registration number
ACTRN12610000717055
Ethics application status
Approved
Date submitted
7/08/2010
Date registered
30/08/2010
Date last updated
24/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
‘ReCaPTure LiFe’: A phase II cluster-randomised controlled trial of a psychological intervention to support young people with cancer and their families to make a positive transition from cancer patient to survivor.
Scientific title
‘ReCaPTure LiFe’: A phase II cluster-randomised controlled trial of a psychological intervention to support young people with cancer and their families to make a positive transition from cancer patient to survivor.
Secondary ID [1] 252394 0
Nil
Universal Trial Number (UTN)
Trial acronym
ReCaPTure LiFe: Resilience and Coping skills for young People and To Live well Following cancer treatment
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distress, psychological adjustment and coping after cancer treatment 257905 0
Condition category
Condition code
Mental Health 258068 258068 0 0
Anxiety
Mental Health 258069 258069 0 0
Depression
Cancer 258123 258123 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 2 arms to this trial. Arm 1: 'ReCaPTure LiFe', a cognitive-behavioural intervention. Arm 2: Supportive Counselling. A third group will be randomised to a 12-week 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. 'ReCaPTure LiFe' will be delivered in 6 x 90-minute group sessions, delivered weekly over the internet using web-conferencing technology and by a clinical psychologist. These sessions will focus on the acquisition and application of cognitive-behavioural skills, such as cognitive restructuring and problem-solving, to the experience of returning to normality post cancer treatment. There is also a one-off 'booster' session 6-weeks following the completion of the main 6-session group program. The intervention will be offered to adolescents and young adults (AYAs) aged 15-25 years who are 1-12 months post active treatment. Participants will complete a 1-week, 3-month and 12-month follow-up, after which their study participation will conclude.
Intervention code [1] 256959 0
Behaviour
Intervention code [2] 256960 0
Treatment: Other
Intervention code [3] 257011 0
Prevention
Comparator / control treatment
The Supportive Counselling condition uses the same group format, delivered over the internet by a clinical psychologist for six, weekly, 90 minute sessions. This therapy includes nondirective counselling that does not include any Cognitive Behaviour Therapy components, but will instead simply give young cancer survivors an open forum to discuss their experience. There is also a one-off 'booster' session 6-weeks following the completion of the main 6-session group program. The intervention will be offered to adolescents and young adults (AYAs) aged 15-25 years who are 1-12 months post active treatment. Participants will complete a 1-week, 3-month, and 12-month follow-up, after which their study participation will conclude.
Control group
Active

Outcomes
Primary outcome [1] 258932 0
Depression, anxiety and stress symptoms as measured by the Depression Anxiety and Stress Scale - Short Form (DASS-21)
Timepoint [1] 258932 0
Pretreatment, 1 week Follow-Up, 12-Month Follow-Up
Primary outcome [2] 258933 0
Impact of Cancer Scale (IOCS) to measure cancer-specific changes in quality of life.
Timepoint [2] 258933 0
Pretreatment, 1 week Follow-Up, 3-month follow-up, 12-Month Follow-Up
Primary outcome [3] 258934 0
KIDCOPE-Older Version will be used to assess adaptive coping strategies.
Timepoint [3] 258934 0
Pretreatment, 1 week Follow-Up, 3-month follow-up, 12-Month Follow-Up
Secondary outcome [1] 265100 0
Family interactions and communication will be measured using three subscales from the McMaster Family Assessment Device (FAD; Epstein, Baldwin L.M., & Bishop, 1983), including Problem Solving (5 items), Communication (6 items), and General Functioning (12 items) subscales.
Timepoint [1] 265100 0
Pretreatment, 3-Month Follow-Up, 12-Month Follow-Up
Secondary outcome [2] 265101 0
Centrality of Event Scale-Short Form, to measure the ongoing impact of the cancer in terms of young people's perceptions of their identity and life goals.
Timepoint [2] 265101 0
Pretreatment, 3-Month Follow-Up, 12-Month Follow-Up

Eligibility
Key inclusion criteria
* Eligible participants will be (1) Young cancer survivors who have finished treatment and are aged 15-25; (2) Able to give informed consent; (3) Fluent in English; (4) able to provide the name and contact details of a trusted health professional (e.g., local general practitioner, family doctor or hospital social worker); and 5) be able to access the Internet in a private location Young people who have previously relapsed (and are finished relapse treatment) will be encouraged to participate. Internet access and a suitable computer set-up is a requirement to participate in Recapture Life-AYA. This includes access to a computer/laptop which has a microphone and web-camera, and is located such that the participant will be able to participate in the sessions comfortably and in a private and uninterrupted capacity once per week for six weeks. AYAs without access to these resources will be able to borrow a laptop, web-camera, microphone and/or wireless internet connection device for the duration of the study (the costs ofwhich are covered by a project grant). The equipment and internet needs of all AYA participants will be assessed at the initial telephone intake interview,and access issues managed on a case-by-case basis.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals may not participate if they
(1) cannot speak English;
(2) exhibit suicidal intent, psychotic features, or substance dependence;
(3) are receiving active treatment, or palliative care. This includes if a patient 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)
Participants will be recruited 0-12 months after treatment completion, from one of several interstate hospital sites. Each potential participant will be sent a personalised invitation letter from their oncologist, a consent form and an opt-in card. Participants who opt-in will be placed on a waiting list for the next intervention. Group allocation will occur by personnel holding the allocation schedule located at another, separate 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 young cancer survivors off-treatment'.
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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This trial will employ ‘Intention to treat’ and ‘as treated’ analyses. Analyses will be based on mixed random-intercept models which will assess differences between the groups in terms of change in QoL from T1 to T2, and from T1 to T3. Random intercept models, which utilise maximum-likelihood estimation, provide more efficient estimates of effects with unbalanced data than the traditional repeated measures approach (Myung, 2003). Analyses will follow recent commentaries on the best way to manage missing data by employing multiple imputation techniques. Multiple regression analyses will also be conducted using T1 data to identify demographic and other factors that contribute to treatment outcome. Multiple comparisons will be used to test a priori and post-hoc hypotheses, appropriately adjusted to maintain the nominated Type I error rate.
A sample size of 90 (assuming equal numbers in each group, and a correlation between T1 and T2 of .6) will allow differences of d=0.65 (calculated as the difference in change from T1 to T2 for any pair of groups, standardised on the pooled within-group standard deviation)- a medium-large effect- on the primary outcome variable (QoL) to be detected with a power of 80% at a significance level of 0.05 (two-tailed). This effect size is clinically significant55 and is based on other RCTs of similar interventions for AYAs with chronic illness (eg., Channon et al., 2007; Hampel et al., 2003). It is anticipated that approximately 220 patients will need to be approached to achieve a final sample of 90 participants (assuming a response rate of 50% and attrition rate of 20%, based on our previous research. This is feasible, based on estimates the potentially eligible AYAs treated annually at our recruiting sites, which include: NSW AYA Service (~140 patients), the Victorian AYA Service (~100 eligible patients), SCH (~15 patients), Children’s Hospital at Westmead (~20 patients), Sir Charles Gardner Hospital, Perth (~30 patients) and the AYA Cancer Service, Women’s and Children’s Hospital, Adelaide (~20 patients). These sites will yield a possible pool of 325 patients eligible for the study during the recruitment phase.

REFERENCES
Channon et al. A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes. Diabetes Care 2007;30:1390-5.
Hampel et al. Multimodal patient education program with stress management for childhood and adolescent asthma. Patient Educ Couns 2003;49:59-66.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
3/12/2012
Actual
14/01/2013
Date of last participant enrolment
Anticipated
Actual
15/09/2015
Date of last data collection
Anticipated
Actual
16/11/2016
Sample size
Target
90
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 257414 0
Hospital
Name [1] 257414 0
Centre for Children's Cancer & Blood Disorders
Country [1] 257414 0
Australia
Funding source category [2] 287746 0
Charities/Societies/Foundations
Name [2] 287746 0
Cancer Australia (co-funded grant in 2012 with Beyond Blue)
Country [2] 287746 0
Australia
Funding source category [3] 287747 0
Charities/Societies/Foundations
Name [3] 287747 0
Beyond Blue (co-funded grant in 2012 with Cancer Australia)
Country [3] 287747 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Psychology,
University of New South Wales,
Anzac Parade,
Kensington, Sydney, 2052,
NSW
Country
Australia
Secondary sponsor category [1] 256647 0
Hospital
Name [1] 256647 0
Sydney Children's Hospital
Address [1] 256647 0
Kids Cancer Centre, Level 1, South Wing, Sydney Children's Hospital, High Street, Randwick, Sydney, 2031, NSW
Country [1] 256647 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259438 0
South Eastern Sydney Local Health District- Northern Section Ethics Committee
Ethics committee address [1] 259438 0
Ethics committee country [1] 259438 0
Australia
Date submitted for ethics approval [1] 259438 0
31/08/2010
Approval date [1] 259438 0
20/02/2012
Ethics approval number [1] 259438 0

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

Contacts
Principal investigator
Name 31489 0
Dr Claire Wakefield
Address 31489 0
Kids Cancer Centre, Level 1 South, Sydney Children's Hospital, Randwick NSW 2031.
Country 31489 0
Australia
Phone 31489 0
(+612) 9382-3113
Fax 31489 0
Email 31489 0
[email protected]
Contact person for public queries
Name 14736 0
Claire Wakefield
Address 14736 0
Kids Cancer Centre, Level 1 South Wing Sydney Children's Hospital High Street Randwick NSW 2031
Country 14736 0
Australia
Phone 14736 0
(+612) 9382 3113
Fax 14736 0
Email 14736 0
[email protected]
Contact person for scientific queries
Name 5664 0
Claire Wakefield
Address 5664 0
Kids Cancer Centre, Level 1 South Wing Sydney Children's Hospital High Street Randwick NSW 2031
Country 5664 0
Australia
Phone 5664 0
(+612) 9382 3113
Fax 5664 0
Email 5664 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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