A 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.
BACKGROUND
This paper presents the rationale and study protocol for a pragmatic controlled effectiveness trial of Truce, a prevention-based selective intervention targeting the significant mental health needs of young people who have a parent with cancer.


METHODS
Truce is a seven week, facilitated, face-to-face group program. The design is a 2 groups (intervention vs control) x 3 (pre-treatment vs post-treatment vs 2 month follow-up) repeated measures. Allocation to groups will be dependent upon recruitment; when groups have sufficient numbers, they will be assigned to the intervention condition, but participants recruited without a viable group will be assigned to the wait-list control condition. Eligible participants are young people aged 14 to 22 years who have a parent diagnosed with cancer within the last 5 years. Wait-list controls are offered the opportunity to participate in the program once they have completed their follow-up questionnaires. The target sample size is 65 participants in each condition. The primary hypothesis is that participants in the intervention will show significant reductions in distress and increases in psychological well-being relative to participants in the wait-list control group, and these effects will continue through two-month follow-up. Mixed-models analysis of variance will be used to measure differences between the two conditions. Secondary analyses will focus on variables which may relate to the effectiveness of the intervention: ACT-related concepts of experiential avoidance and mindfulness, family functioning, unmet needs and demographic variables. We will also assess program fidelity and satisfaction.


CONCLUSIONS
The development and evaluation of a manualised intervention for young people with a parent with cancer responds to a gap in the provision of empirically-based psychological support for this vulnerable group.


BACKGROUND
Australian and New Zealand Clinical Trials Registry ACTRN12615000761561. Registered 22(nd) July 2015.
Research, Evaluation and Social Policy, CanTeen, Sydney, Australia. pandora.patterson@canteen.org.au.|Cancer Nursing Research Unit, Faculty Nursing, University of Sydney, Sydney, Australia. pandora.patterson@canteen.org.au.
Pandora
P
Patterson
Research, Evaluation and Social Policy, CanTeen, Sydney, Australia. fiona.mcdonald@canteen.org.au.|Cancer Nursing Research Unit, Faculty Nursing, University of Sydney, Sydney, Australia. fiona.mcdonald@canteen.org.au.
Fiona E J
FE
McDonald
Institute of Positive Psychology and Education, Australian Catholic University, Sydney, Australia. Joseph.ciarrochi@acu.edu.au.
Joseph
J
Ciarrochi
Orygen, The National Centre of Excellence in Youth Mental Health, University of Melbourne, Melbourne, Australia. louiseh@unimelb.edu.au.
Louise
L
Hayes
School of Education, University of Western Sydney, Sydney, Australia. d.tracey@uws.edu.au.
Danielle
D
Tracey
School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia. c.wakefield@unsw.edu.au.|Behavioural Sciences Unit, Kids Cancer Centre, Sydney Children's Hospital, Sydney, Australia. c.wakefield@unsw.edu.au.
Claire E
CE
Wakefield
Cancer Nursing Research Unit, Faculty Nursing, University of Sydney, Sydney, Australia. Kate.white@sydney.edu.au.
Kate
K
White
D064869:Acceptance and Commitment Therapy / Q000379:methods*; D000293:Adolescent; D001315:Australia; D005260:Female; D006801:Humans; D008297:Male; D008603:Mental Health; D009369:Neoplasms / Q000523:psychology; D009520:New Zealand; D010290:Parents; D012107:Research Design; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult