Journal Article

Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study

Thomas Berger, Judith Alder, Astrid Grossert, Corinne Urech, Jens Gaab, Viviane Hess

2016

Overview

Background Being 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/design In 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. Discussion New 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 registration ClinicalTrials.gov NCT02289014 .

• Publisher: Springer Science and Business Media LLC,BioMed Central,Springer Nature B.V
• Subject: 150 Psychology / 610 Medicine & health / Anxiety / Biomedical and Life Sciences / Biomedicine / Cancer Research / Cancer therapies / Clinical trials / Disease Management / Early Medical Intervention / Emotions / Epidemiology / Genetics / Health Promotion and Disease Prevention / Humans / Internet / Internet - utilization / Intervention / Medicine/Public Health / Mental depression / Mental disorders / Mindfulness / Neoplasms / Neoplasms - diagnosis / Neoplasms - psychology / Oncology / Patients / prevention and public health / Prognosis / Prospective Studies / Psychologists / Psychotherapy / Quality of Life / Research Design / Stress / Stress, Psychological / Stress, Psychological - prevention & control / Study Protocol / Surgical Oncology / Usability / Waiting Lists