None listed
Conditions
Brief summary
This study looks at the effectiveness of a psychological therapy designed to support young people with cancer and their families to make a positive transition from cancer patient to survivor. Who is it for? You can join this study if you are a young cancer survivor aged 15-25 who has finished treatment for either a primary or secondary cancer in the past 12 months. Trial details: Participants will be divided into two groups. One group will take part in 'ReCaPTure LiFe', a cognitive-behavioural program designed to help people build skills to return to normality after cancer treatment. This will take place in six 90-minute group sessions, delivered weekly over the internet. Participants will complete a 1-week, 3-month and 12-month follow-up. The second group will take part in an open discussion forum with the same schedule. The study aims to monitor the distress, psychological adjustment and coping after cancer treatment.
Interventions
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.
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.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
15 Years to 25 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed