Abstract
BackgroundBeing diagnosed with cancer causes major psychological distress, yet the majority of newly diagnosed cancer patients lack psychological support. Internet interventions overcome many barriers for seeking face-to-face support and allow for independence in time and place. We assess efficacy and feasibility of the first web-based stress management intervention (STREAM: STREss-Aktiv-Mindern) for newly diagnosed, German-speaking cancer patients.Methods/designIn a prospective, wait-list controlled trial 120 newly diagnosed cancer patients will be included within 12 weeks of starting anti-cancer treatment and randomized between an immediate (intervention group) or delayed (control group) 8-week, web-based intervention. The intervention consists of eight modules with weekly written feedback by a psychologist (“minimal-contact”) based on well-established stress management manuals including downloadable audio-files and exercises. The aim of this study is to evaluate efficacy in terms of improvement in quality of life (FACT-F), as well as decrease in anxiety and depression (HADS), as compared to patients in the wait-list control group. A sample size of 120 patients allows demonstrating a clinically relevant difference of nine points in the FACT score after the intervention (T2) with a two-sided alpha of 0.05 and 80 % power. As this is the first online stress management intervention for German-speaking cancer patients, more descriptive outcomes are equally important to further refine the group of patients with the largest potential for benefit who then will be targeted more specifically in future trials. These descriptive endpoints include: patients’ characteristics (type of cancer, type of treatment, socio-demographic factors), dropout rate and dropout reasons, adherence and satisfaction with the program.DiscussionNew technologies open new opportunities: minimal-contact psychological interventions are becoming standard of care in several psychological disorders, where their efficacy is often comparable to face-to-face interventions. With our study we open this field to the population of newly diagnosed cancer patients. We will not only assess clinical efficacy but also further refine the target population who has the most potential to benefit. An internet-based minimal-contact stress management program might be an attractive, time- and cost-effective way to effectively deliver psychological support to newly diagnosed cancer patients and an opportunity to include those who currently are not reached by conventional support.Trial registrationClinicalTrials.gov NCT02289014.
Highlights
What is stress?Nature of stress in general and in specific cancer-related situations2
Efficacy of psycho-oncological interventions and Utilization of psycho-oncological support Cognitive behavioural techniques, including relaxation techniques [7] and mindfulness based stress reduction [8], significantly reduce distress, depression and fatigue and increase quality of life in cancer patients, albeit effect sizes in randomized controlled trials are small to medium [9]
Intervention We developed the web-based intervention STREAM based on well-described and established stress management interventions manuals [29,30,31,32,33], which we adapted to the web-context
Summary
What is stress?Nature of stress in general and in specific cancer-related situations2. Efficacy of psycho-oncological interventions and Utilization of psycho-oncological support Cognitive behavioural techniques, including relaxation techniques [7] and mindfulness based stress reduction [8], significantly reduce distress, depression and fatigue and increase quality of life in cancer patients, albeit effect sizes in randomized controlled trials are small to medium [9]. Many patients do not seek or have access to psychooncological support, even when high levels of distress are experienced [14]. This seems especially true for male patients [15, 16] and patients with cancer other than female breast cancer [15]
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