Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000485730p
Ethics application status
Submitted, not yet approved
Date submitted
2/03/2022
Date registered
28/03/2022
Date last updated
28/03/2022
Date data sharing statement initially provided
28/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Resilience for Adolescents and Young People Study (RAYS). An interventional study for offspring of women with breast cancer
Scientific title
Resilience for Adolescents and Young People Study (RAYS). A support-based interventional study examining the effect on distress in offspring of women with breast cancer
Secondary ID [1] 306558 0
BCRC130
Universal Trial Number (UTN)
Trial acronym
RAYS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distress 325454 0
Anxiety 325573 0
Condition category
Condition code
Mental Health 322834 322834 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants comprise mothers with breast cancer and their child(ren) aged between 14-24 years.
Consenting participants' mental health needs relating to their mother's cancer diagnosis will be assessed by a qualified clinical psychologist in a 30-60 minute session to talk about how the participant is coping and about any emotional concerns they may have. After the discussion, the psychologist will make suggestions about ways to support the participant further if needed.
The participant will then enter into one of four cohorts:
1. no further intervention required
2. information provision - information about the mother's breast cancer diagnosis and ways to access further services if required will be provided by the clinical psychologist. Information will be both verbal and written and age-appropriate and has been designed by the clinical psychologists involved in this study.
3. referral to external agencies for those participants deemed by the clinical psychologist to be most likely to derive benefit from external support rather than in-house counselling Factors may include:
• Acute economic or social crisis, experiencing suicidal ideation, current psychosis, or in a high-risk situation.
• Current severe alcohol or substance misuse.
• Primarily needing assistance for issues unrelated to mother’s breast cancer e.g., obsessive compulsive disorder, eating disorders

External service providers may include, but are not limited to:
• Non-government organisation – Relationships Australia, Anglicare, Women’s health & family services – Kids in Focus (no – low cost)
• Canteen – support services for young people aged 12-25 who have a parent with cancer (no cost)
• Private Clinician (e.g., Mental health professionals such as clinical psychologist, psychologist, clinical social worker, psychiatrist) (cost)
• Community Mental Health Service – WA Health department – depending on age of young person, if significant and severe mental health concerns are identified a referral can be made together, with their GP (no cost)

4. Participants in cohort 4 will be offered individual sessions with the clinical psychologist, with the duration of sessions based on clinical judgement and for up to 6 sessions. The focus of the sessions will include information, skills and strategies for moderating variables such as mother’s depression, mother’s coping and parenting style.

Participants’ primary family physician will be provided with a written summary of concerns and the recommendation made by the clinical psychologist.

Confirmation of intervention adherence in cohorts 2 and 4 will be documented in psychologist’s records. Adherence to a recommended external provider cannot be objectively confirmed but will be self-reported by participants.
Intervention code [1] 322988 0
Behaviour
Comparator / control treatment
Comparison will be made against Cohort 1 - group of participants for whom no further intervention is required
Control group
Active

Outcomes
Primary outcome [1] 330615 0
Changes in the level of very high and high distress as measured by the Kessler Psychological Distress Scale - K10 in Cohorts 2 to 4 will be identified
Timepoint [1] 330615 0
Approximately 4 months from date of patient enrollment
Secondary outcome [1] 406978 0
Changes in the perceived level of family functioning in the offspring and their mother with breast cancer, as measured by the McMaster Family Assessment Device (FAD), following engagement in the stepped model of care will be identified
Timepoint [1] 406978 0
Approximately 4 months from the date of patient enrollment
Secondary outcome [2] 407276 0
Mother’s satisfaction with the intervention will be assessed by the Client Satisfaction Questionnaire (CSQ).
Timepoint [2] 407276 0
Approximately 4 months from the date of patient enrolment
Secondary outcome [3] 407277 0
To assess moderating variable of mother's mental health as assessed by the Hospital Anxiety and Depression Scale
Timepoint [3] 407277 0
Baseline and approximately 4 months from the date of patient enrollment
Secondary outcome [4] 407846 0
Child's satisfaction with the intervention will be assessed by the Client Satisfaction Questionnaire (CSQ).
Timepoint [4] 407846 0
Approximately 4 months from date of participant enrollment

Eligibility
Key inclusion criteria
• Written informed consent of participants (parental/legal guardian consent required in subjects under 18 years)
• Written informed consent of the parent “Consent for Use of Personal Health Information”
• Parent must be a current patient of Perth Breast Cancer Institute (clinical arm of BCRC-WA) clinician(s).
• Parent includes biological or non-biological (i.e., Adoptive or Foster)
• Parent diagnosed with stage I to IV breast cancer (including those who remain disease-free from breast cancer, have experienced a local recurrence or have metastatic breast cancer) within the last 5 years
• Parent has life expectancy greater than 6 months.
• Male and female offspring aged between 14-24yrs at the time of consent
• Living with the parent (applicable to offspring 14-17 years of age)
• Both parent and offspring able to read English and understand questions asked
• Both parent and offspring who resides in Western Australia
• Offspring whose parent with breast cancer is the sole parent may be included.
• Offspring with personal cancer if treatment has finished and in remission are eligible
• Evidence of no disease progression in patients with metastatic breast cancer within 3 months prior to study consent (i.e the mother is assessed as having stable metastatic disease)
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• No social contact with mother who has breast cancer.
• Diagnosis of severe mental health problems, including recent suicidal and self-harm behaviours within the last 3 months.
• Father or sibling currently being treated for cancer.

Study design
Purpose of the study
Educational / counselling / training
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
It is anticipated that the primary outcome (K10 score) will be reduced by 7 points as a result of the interventions recommended. Assuming a conservative standard deviation of 9 points, and 10% attrition rate, 30 patients per cohort 1 to 4 are needed to detect the difference with 80% power and a 5% significance. As such, a total of 120 patients are required to compare Cohorts 2, 3 and 4 against Cohort 1.
Baseline participant characteristics, parent demographics and cancer characteristics will be described by participant age (14-18 vs 19-24 years old), and cohort (1, 2, 3 and 4). Changes in K10 score will be reported for each cohort.
Further analyses of the changes in K10 score by cohort will be performed by multiple linear regression whilst controlling for the baseline K10 score, age, parent HADS. Prevalence of high and very high distress levels at baseline and follow-up will be reported and compared using paired proportion tests for each cohort. Post-intervention scores of other secondary measures (FAD,) by cohort will be assessed using multiple linear regressions whilst controlling for age, the baseline K10, FAD, parent HADS


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/04/2022
Actual
Date of last participant enrolment
Anticipated
4/04/2024
Actual
Date of last data collection
Anticipated
7/08/2024
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 21852 0
Breast Cancer Research Centre - Western Australia - Perth
Recruitment postcode(s) [1] 36915 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 310891 0
Charities/Societies/Foundations
Name [1] 310891 0
Breast Cancer Research Centre - WA
Country [1] 310891 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Breast Cancer Research Centre - WA
Address
Suite 407, Level 4
91 Monash Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 312170 0
None
Name [1] 312170 0
Address [1] 312170 0
Country [1] 312170 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310452 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 310452 0
Ethics committee country [1] 310452 0
Australia
Date submitted for ethics approval [1] 310452 0
18/01/2022
Approval date [1] 310452 0
Ethics approval number [1] 310452 0

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

Contacts
Principal investigator
Name 117718 0
Prof Arlene Chan
Address 117718 0
Breast Cancer Research Centre - WA
Suite 406, Level 4
91 Monash Ave
Nedlands WA 6009
Country 117718 0
Australia
Phone 117718 0
+61894814522
Fax 117718 0
Email 117718 0
[email protected]
Contact person for public queries
Name 117719 0
Linda Armstrong
Address 117719 0
Breast Cancer Research Centre - WA
Suite 407, Level 4
91 Monash Ave
Nedlands WA 6009
Country 117719 0
Australia
Phone 117719 0
+61865005501
Fax 117719 0
Email 117719 0
[email protected]
Contact person for scientific queries
Name 117720 0
Arlene Chan
Address 117720 0
Breast Cancer Research Centre - WA
Suite 406, Level 4
91 Monash Ave
Nedlands WA 6009
Country 117720 0
Australia
Phone 117720 0
+61894814522
Fax 117720 0
Email 117720 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Requests from external source for deidentified data for inclusion in other appropriate similar research will be on a case to case basis and final decision to release data will be made by the PI
When will data be available (start and end dates)?
Fulfilling the above criteria after completion of study and publication of primary results (start date) up to 5 years from publication (end date)
Available to whom?
Legitimate researchers involved in similar research as assessed and approved by the PI
Available for what types of analyses?
Legitimate researchers involved in similar research as assessed and approved by the PI
How or where can data be obtained?
Contact via www.bcrc-wa.com.au


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.