Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001399583
Ethics application status
Approved
Date submitted
31/10/2024
Date registered
26/11/2024
Date last updated
26/11/2024
Date data sharing statement initially provided
26/11/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Community Implementation of the ‘Recapture Life’ Online Program for
Adolescent and Young Adult Cancer Survivors
Scientific title
Community Implementation of the ‘Recapture Life’ Online Program for
Adolescent and Young Adult Cancer Survivors
Secondary ID [1] 313118 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record
This current study is an entirely new study to the trial ACTRN12610000717055. However, it is related to that study via the same study coordinators, and is testing an adapted version of the intervention that was being tested in ACTRN12610000717055 ("Recapture Life") - in new settings. The intervention is adapted, the settings are different, intervention facilitators different, trial outcomes/endpoints different, and the target population has also changed (now extends up to 39 years).

Health condition
Health condition(s) or problem(s) studied:
Distress after cancer treatment. 335396 0
Quality of Life after cancer treatment. 335400 0
Condition category
Condition code
Cancer 331967 331967 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study builds on a recent RCT comparing the impact of a theoretically grounded, online intervention (Recapture Life) to teach adaptive cognitive behavioural therapy (CBT) coping skills to promote resilience in early survivorship. Participants who choose to participate in Recapture Life received six weekly 90 minute sessions delivered online. Each group consisted of a facilitator plus 3-6 adolescents and young adults (AYA)s with mixed cancer diagnoses and genders. Sessions were delivered through a secure, password-protected video conferencing software. Each 90-minute module included both psychological skills and cancer related content, applying CBT techniques to the key domains of concern identified by previous studies, including fear of cancer recurrence and changes to activity levels. Participants will also complete a one-on-one booster session with their group facilitator six weeks after the completion of session six. The purpose of the booster session was to help the participants to review their past six weeks in light of skills/psychoeducation learnt., and to prompt them to consider what thoughts and feelings both positive and negative/challenging situations have brought up, and times they have used any skills from Recapture Life.

Staff were eligible to deliver Recapture Life if they were a registered healthcare professional (including but not limited to psychologists, clinical psychologists, and nurses); had prior experience in the delivery of a cognitive-behaviour therapy group treatment program; and were determined by the community organisation as having sufficient experience to deliver the program. .

The study design involves simple pre- and post-intervention measures. AYA participants completed questionnaires at intake (T1), and six-months later, after the completion of the intervention and the booster session (T2). These were completed online through a secure questionnaire portal. Questionnaires obtained participant demographic data, assessed Quality of Life (the primary outcome variable), psychological distress, and peer support.
Intervention code [1] 329711 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339581 0
Quality of life
Timepoint [1] 339581 0
Intake, before intervention, and six months later (after completion of the intervention and booster session).
Secondary outcome [1] 440495 0
Peer support
Timepoint [1] 440495 0
Intake, before intervention, and six months later (after completion of the intervention and booster session).
Secondary outcome [2] 440494 0
Psychological distress
Timepoint [2] 440494 0
Intake, before intervention, and six months later (after completion of the intervention and booster session).

Eligibility
Key inclusion criteria
* Eligible participants will be (1) Young cancer survivors who have finished treatment and are aged 13-39; (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. 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 of which 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
13 Years
Maximum age
39 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary outcome measure for evaluating Recapture Life’s effectiveness will be changes in Quality of Life between baseline and 6 months post as operationalised by the score on the Distress Thermometer and Problem Checklist. Secondary outcome measures will include general functioning, peer support, and distress. Linear mixed models will be used to assess differences factors affecting change in quality of life across time points. Significant effects will be further examined using pairwise contrasts that compare Quality of Life at T1 to T2, and will be appropriately adjusted to account for an inflated Type I error rate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/09/2019
Date of last participant enrolment
Anticipated
Actual
3/02/2022
Date of last data collection
Anticipated
Actual
24/08/2022
Sample size
Target
112
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 317585 0
Charities/Societies/Foundations
Name [1] 317585 0
The Swedish Childhood Cancer Fund
Country [1] 317585 0
Sweden
Funding source category [2] 317586 0
Other Collaborative groups
Name [2] 317586 0
Maridulu Budyari Gumal SPHERE, Cancer Clinical Academic Group
Country [2] 317586 0
Australia
Funding source category [3] 317563 0
Charities/Societies/Foundations
Name [3] 317563 0
Cancer Council New South Wales Program Grant (PG16-02) with the support of the Estate of the Late Harry McPaul
Country [3] 317563 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 319868 0
Hospital
Name [1] 319868 0
Sydney Children's Hospital
Address [1] 319868 0
Country [1] 319868 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316274 0
The University of New South Wales Committee C
Ethics committee address [1] 316274 0
Ethics committee country [1] 316274 0
Australia
Date submitted for ethics approval [1] 316274 0
29/11/2016
Approval date [1] 316274 0
01/02/2017
Ethics approval number [1] 316274 0

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

Contacts
Principal investigator
Name 137358 0
Dr Ursula Sansom-Daly
Address 137358 0
Kids Cancer Centre, Level 1 South, Sydney Children's Hospital, High St., Randwick NSW 2031, Australia.
Country 137358 0
Australia
Phone 137358 0
+61293823114
Fax 137358 0
Email 137358 0
[email protected]
Contact person for public queries
Name 137359 0
Ursula Sansom-Daly
Address 137359 0
Kids Cancer Centre, Level 1 South, Sydney Children's Hospital, High St., Randwick NSW 2031, Australia.
Country 137359 0
Australia
Phone 137359 0
+61293823114
Fax 137359 0
Email 137359 0
[email protected]
Contact person for scientific queries
Name 137360 0
Ursula Sansom-Daly
Address 137360 0
Kids Cancer Centre, Level 1 South, Sydney Children's Hospital, High St., Randwick NSW 2031, Australia.
Country 137360 0
Australia
Phone 137360 0
+61293823114
Fax 137360 0
Email 137360 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.