Background: Faced with a life-threatening illness, such as cancer, many patients develop stress symptoms, i.e.\r\navoidance behaviour, intrusive thoughts and worry. Stress management interventions have proven to be effective;\r\nhowever, they are mostly performed in group settings and it is commonly breast cancer patients who are studied.\r\nWe hereby present the design of a randomized controlled trial (RCT) evaluating the effectiveness and\r\ncost-effectiveness of an individual stress-management intervention with a stepped-care approach in several cancer\r\ndiagnoses.\r\nMethod: Patients (= 18 years) with a recent diagnosis of breast cancer, colorectal cancer, lymphoma, prostate\r\ncancer or testicle cancer and scheduled for adjuvant/curative oncology treatment, will consecutively be included in\r\nthe study. In this prospective longitudinal intervention study with a stepped-care approach, patients will be\r\nrandomized to control, treatment as usual, or an individual stress-management intervention in two steps. The first\r\nstep is a low-intensity stress-management intervention, given to all patients randomized to intervention. Patients\r\nwho continue to report stress symptoms after the first step will thereafter be given more intensive treatment at the\r\nsecond step of the programme. In the intervention patients will also be motivated to be physically active.\r\nAvoidance and intrusion are the primary outcomes. According to the power analyses, 300 patients are planned to\r\nbe included in the study and will be followed for two years. Other outcomes are physical activity level, sleep\r\nduration and quality recorded objectively, and anxiety, depression, quality of life, fatigue, stress in daily living, and\r\npatient satisfaction assessed using valid and standardized psychometric tested questionnaires. Utilization of hospital\r\nservices will be derived from the computerized patient administration systems used by the hospital. The\r\ncost-effectiveness of the intervention will be evaluated through a cost-utility analysis.\r\nDiscussion: This RCT will provide empirical evidence of whether an individually administered stress-management\r\nprogramme in two steps can decrease stress as well as maintain or enhance patients� physical activity level, quality\r\nof life and psychological well-being. Further, this RCT, with a stepped-care approach, will provide knowledge\r\nregarding the cost-effectiveness of an individually administered stress-management programme whose aim is to\r\nhelp and support individual patients at the right level of care.
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