Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000761561
Ethics application status
Approved
Date submitted
25/06/2015
Date registered
22/07/2015
Date last updated
24/11/2020
Date data sharing statement initially provided
11/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Truce: A pragmatic controlled trial of a seven-week Acceptance and Commitment Therapy program for young people who have a parent with cancer
Scientific title
Evaluation of a group-based Acceptance and Commitment Therapy intervention for the reduction of distress and increase in psychological wellbeing in AYA offspring of cancer patients relative to wait-list controls
Secondary ID [1] 286960 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress related to having a parent with cancer 295417 0
Condition category
Condition code
Mental Health 295672 295672 0 0
Other mental health disorders
Cancer 295746 295746 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The administration of Truce, a manualised, structured Acceptance and Commitment Therapy program for adolescents and young adults (AYAs) with a parent with cancer. The program is delivered orally in a group format, by two psychologists/social workers with training in ACT. Groups consist of 4-8 participants and runs once a week for 7 sessions of 1.5-2 hours duration, for an overall duration of 7 weeks. Parallel to the intervention one parent of the participant (not necessarily the parent with cancer) is given a psychoeducational booklet which provides details about the program, ACT and research findings regarding the impact on children of having a parent with cancer. Session 6 is a joint participant-parent session. The content of session 6 follows on from the content of the parent psychoeducational booklet and provides an opportunity for the participants and their parents to discuss issues pertinent to the family situation when a parent has cancer.


Homework is administered through weekly tasks with a participant booklet. Homework exercises consist of small daily tasks that would take approximately 30-60 minutes per week. Fidelity to the program measured by facilitator compliance to the manualised program, homework compliance and participant engagement. Facilitator compliance is measured through written logs of each group session which is sent to the independent administrating team and discussed at weekly briefing/debriefing meetings. Homework compliance is measured by a homework log that is completed by the participant at each session and forwarded to the administration team. Participant engagement is measured through a 10-point scale of session engagement administered to each participant at the end of each session.
Intervention code [1] 292165 0
Treatment: Other
Intervention code [2] 292235 0
Behaviour
Comparator / control treatment
wait-list control group comprises of participants who are interested in the program but unable to attend the group or it is not available in their area. Provided with an informational booklet until eligible/available for group participation.
The informational booklet is uses psychoeducation: about cancer, treatment, some of the common family changes that can result from having a parent with cancer and practical suggestions for support and emotional regulation.
Control group
Active

Outcomes
Primary outcome [1] 295375 0
K10 Distress score
Timepoint [1] 295375 0
baseline, post intervention and 2-month post intervention follow-up
Secondary outcome [1] 315464 0
RADS Depression Score
Timepoint [1] 315464 0
Baseline, post intervention and 2-month post intervention follow-up
Secondary outcome [2] 315465 0
Keyes Psychological Wellbeing Score
Timepoint [2] 315465 0
Baseline, post intervention and 2-month post intervention follow-up

Eligibility
Key inclusion criteria
Participants need to be aged between 14 and 22 years
Able to read English
Able to provide informed consent
And have a parent/caregiver with a current (last 5 years) diagnosis of cancer, not currently in palliative care or terminal
Minimum age
14 Years
Maximum age
22 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bereaved
Currently engaged in other psychosocial treatments
Considered to be too highly distressed or in need of urgent support

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample will include a total of 140 young people who have a parent with cancer and, where possible, one parent of each young person. The number of required participants is based on sample size analyses assuming: 80% power, alpha of 0.05 and a minimally important change in K10 scores of 4.9 (effect size of 0.5). According to these calculations, 70 participants are needed in each of the intervention conditions.

Descriptive statistics will be used to report demographic information. Fidelity and satisfaction measures will also be summarised. Missing data will be managed using multiple imputation techniques. The impact of the treatment condition on the change in outcome variables will be assessed using mixed-models statistical analysis. Secondary analyses (such as testing for potential moderators and mediators) will be conducted using multiple regression statistical techniques.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
1/09/2012
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
131
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291521 0
Charities/Societies/Foundations
Name [1] 291521 0
CanTeen Australia
Country [1] 291521 0
Australia
Funding source category [2] 291522 0
Charities/Societies/Foundations
Name [2] 291522 0
Australian Rotary Health
Country [2] 291522 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
CanTeen
Address
75 King St, Newtown NSW 2042
Country
Australia
Secondary sponsor category [1] 290204 0
None
Name [1] 290204 0
Address [1] 290204 0
Country [1] 290204 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293064 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 293064 0
Ethics committee country [1] 293064 0
Australia
Date submitted for ethics approval [1] 293064 0
30/11/2011
Approval date [1] 293064 0
05/03/2012
Ethics approval number [1] 293064 0
HE11-482

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

Contacts
Principal investigator
Name 58294 0
Dr Pandora Patterson
Address 58294 0
CanTeen Australia
75 King St Newtown NSW 2042
GPO Box 3821 Sydney NSW 2001
Country 58294 0
Australia
Phone 58294 0
+61 2 9007 0212
Fax 58294 0
Email 58294 0
[email protected]
Contact person for public queries
Name 58295 0
Fiona McDonald
Address 58295 0
CanTeen Australia
75 King St Newtown NSW 2042
GPO Box 3821 Sydney NSW 2001
Country 58295 0
Australia
Phone 58295 0
+61 2 9007 0213
Fax 58295 0
Email 58295 0
[email protected]
Contact person for scientific queries
Name 58296 0
Fiona McDonald
Address 58296 0
CanTeen Australia
75 King St Newtown NSW 2042
GPO Box 3821 Sydney NSW 2001
Country 58296 0
Australia
Phone 58296 0
+61 2 9007 0213
Fax 58296 0
Email 58296 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
The individual participant data is strictly confidential. The participants are not consenting that their data will be made available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2396Study protocol    368809-(Uploaded-20-06-2019-12-27-08)-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
SourceTitleYear of PublicationDOI
EmbaseA study protocol for Truce: a pragmatic controlled trial of a seven-week acceptance and commitment therapy program for young people who have a parent with cancer.2015https://dx.doi.org/10.1186/s40359-015-0087-y
N.B. These documents automatically identified may not have been verified by the study sponsor.