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A multicentre phase II randomised controlled trial of a parent/carer-targeted intervention to improve quality of life in families of young cancer survivors.

A multicentre phase II randomised controlled trial of a parent/carer-targeted intervention to improve quality of life in families of young cancer survivors.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000270718
Acronym
"Cascade": A parent/carer-targeted intervention to improve quality of life in families of young canc
Enrollment
76
Registered
2013-03-06
Start date
2014-08-27
Completion date
2017-11-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 clini

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

Sponsors

University of New South Wales
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 17, 2026