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This study investigates the prevalence of adjustment disorders among cancer patients as well as the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>This study consists of two parts. Part 1 is an observational study among a representative group of mixed cancer patients after cancer treatment on the prevalence of adjustment disorder as well as the uptake (i.e. reach) of psychological treatment. In Part 2, patients diagnosed with an adjustment disorder are invited to participate in a randomized controlled trial. Patients will be randomized to the intervention (access to the tailored psychological intervention) or control group (waitlist period of 6\u2009months). The psychological intervention consists of three modules: one module containing psycho-education (3 sessions, all patients) and two additional modules (maximum of 6 sessions per module) provided as continuum, in case needed. Module 2 and 3 can consist of several evidence-based interventions (e.g. group interventions, mindfulness, eHealth) The primary outcome is psychological distress (HADS). Secondary outcomes are mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). To assess the cost-utility and budget impact, quality of life (EQ-5D-5\u2009L) and costs (iMCQ and iPCQ) will be measured. Measures will be completed at baseline and 3 and 6-months after randomization.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>This study will provide data of the prevalence of adjustment disorders and the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>Netherlands Trial Register identifier:<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.trialregister.nl\/trial\/7763\">NL7763<\/jats:ext-link>. Registered on 3 June 2019.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s40359-019-0368-y","type":"journal-article","created":{"date-parts":[[2019,12,23]],"date-time":"2019-12-23T17:02:48Z","timestamp":1577120568000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Prevalence of adjustment disorder among cancer patients, and the reach, effectiveness, cost-utility and budget impact of tailored psychological treatment: study protocol of a randomized controlled trial"],"prefix":"10.1186","volume":"7","author":[{"given":"Florie E.","family":"van Beek","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lonneke M. 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Permission has been obtained to access the Netherlands Cancer Registry.All participants will provide written informed consent to participate in the trial. The trial protocol is published in the Dutch Trial Register (NL7763) and can be accessed at.This study will be conducted according to the principles of the Declaration of Helsinki (version, October 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO). Risks of participation in this study are negligible. If the tailored psychological intervention has shown to be cost-effective, further steps will be taken to support the implementation of this program in clinical practice. First, the Dutch committee commissioned by the Dutch minister of Health, Welfare and Sport published will be informed in order to facilitate the reimbursement of psychological treatment in Dutch mental healthcare. In addition, guideline committees will be informed and recommended to adapt the guidelines on tailored psychological care for cancer patients with an adjustment disorder. Results will be published in peer-reviewed scientific journals.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"89"}}