Design of the study: How can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care

Abstract

BackgroundA life threatening illness such as breast cancer can lead to a secondary diagnosis of PTSD (post traumatic stress disorder) with intrusive thoughts and avoidance as major symptoms. In a former study by the research group, 80% of the patients with breast cancer reported a high level of stress symptoms close to the diagnosis, such as intrusive thoughts and avoidance behavior. These symptoms remained high throughout the study. The present paper presents the design of a randomized study evaluating the effectiveness and cost-effectiveness of a stress management intervention using a stepped-care design.MethodFemale patients over the age of 18, with a recent diagnosis of breast cancer and scheduled for adjuvant treatment in the form of chemotherapy, radiation therapy and/or hormonal therapy are eligible and will consecutively be included in the study. The study is a prospective longitudinal intervention study with a stepped-care approach, where patients will be randomised to one of two interventions in the final stage of treatment. The first step is a low intensity stress-management intervention that is given to all patients. Patients who do not respond to this level are thereafter given more intensive treatment at later steps in the program and will be randomized to more intensive stress-management intervention in a group setting or individually. The primary out-come is subjective distress (intrusion and avoidance) assessed by the Impact of Event Scale (IES). According to the power-analyses, 300 patients are planned to be included in the study and will be followed for one year. Other outcomes are anxiety, depression, quality of life, fatigue, stress in daily living and utilization of hospital services. This will be assessed with well-known psychometric tested questionnaires. Also, the cost-effectiveness of the intervention given in group or individually will be evaluated.DiscussionThis randomized clinical trial will provide additional empirical evidence regarding the effectiveness of a stress-management program given in group or individually during adjuvant therapy in terms of decreased stress, minimizing fatigue, and maintaining or enhancing patients’ quality of life and psychological well-being.Trial registrationClinicalTrials.gov Identifier: NCT01555645

Post-traumatic Stress Disorder and Post-traumatic Growth in Breast Cancer Patients - a Systematic Review

“…Approximately 80% of patients with BC reported high levels of stress at diagnosis. These included negative intrusive thoughts and avoidance behaviour towards treatment (Nordin et al, 2012). Studies done using self-report screening tools (e.g., Hospital Anxiety and Depression Scale, PTSD Checklist Civilian Version, and Short-Form Health Survey) have reported distress, anxiety and depression in one-quarter to one-third of women who present with BC, and the incidence of symptoms can increase gradually up to 50% after diagnosis.…”

“…In some BC survivors, persistent emotional distress can lead to psychological pathology, including anxiety disorders or clinical depression (Nordin et al, 2012). Approximately 80% of patients with BC reported high levels of stress at diagnosis.…”

“…It is clear that BC diagnosis is a trigger for the development of numerous traumatic psychological reactions for the patient (Kangas et al, 2002). Patients who face life threatening diseases like BC experience different stressful events including financial and social worries, fear of recurrence, psycho-social pressure from family and fear of death (Nordin et al, 2012;Arving et al, 2013;Rizalar et al, 2014). The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-lV) report categorises these symptoms as phobias and anxiety (DSM-IV, 2000).…”

“…The review team found five different types of subjects studied, including: i) PTSD in BC survivors (Andrykowski et al, 1998;Andrykowski et al, 2000;Amir and Ramati, 2002;Gurevich et al, 2002;Kangas et al, 2002;Levine et al, 2005;Kangas et al, 2007;Knobf, 2007;Mehnert and Koch, 2008;Shelby et al, 2008;Smith et al, 2008;Bellizzi et al, 2010;Nordin et al, 2012;Rustad et al, 2012;Arving et al, 2013;Perez et al, 2014).…”

Design and development of a stepped-care behavioral intervention to support parents of young children newly diagnosed with type 1 diabetes

“…The UK's National Institute for Health and Care Excellence recommended the implementation of stepped care models for all mental health concerns [42], and non-pharmacological models have been used successfully for substance abuse and weight management interventions [43,44]. Stepped care interventions targeting stress and psychosocial adjustment have shown promising reductions in psychological distress among adults with chronic conditions [45–47]. Currently, ongoing studies are using stepped care to address parental distress among children with chronic illness, including with T1D [48].…”