Evaluating a Novel Web-based Intervention for Breast Cancer Survivors

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
Depression and fatigue is common in breast cancer survivors and its presence is associated with personal suffering, increased inflammatory activity, and worse prognosis. While in the phase of acute treatment many women receive short‐term psychological support to better cope with the situation, this is not standard of care in the years following. Web‐based psychological interventions are easily accessible and preliminary evidence suggests that such interventions can be effective. However, no trial has yet examined whether a CBT‐based internet intervention designed to meet the needs of breast cancer survivors can achieve effects on lifestyle parameters and psychometric outcomes, when offered as adjunct to care as usual. In this study, the investigators will investigate treatment effects of the novel web‐based program Optimune when added to treatment as usual. Beyond established CBT techniques targeting depression, anxiety, and fatigue, this intervention specifically includes elements that have shown effects on markers of immune status and inflammation, including sleep and stress management (e.g., mindfulness‐based techniques) and lifestyle optimization (dietary and physical activity advice). The delivery and training of content is continuously individualized to match users' preferences and needs, based on responses within the program. The intervention is delivered via the internet and protected by individually assigned passwords. The program can be accessed for 365 days after registration. This randomized controlled trial will include 360 women with breast cancer who are past the active eradication phase. Participants will be recruited from various settings, including web‐based advertisement and internet forums/groups. Participants will be randomly assigned to either (1) a control group, in which they receive care as usual (CAU) and are given access to the web‐based intervention (Optimune) after a delay of 3 months (i.e., CAU/wait list control group), or (2) a treatment group that may also use CAU and in addition immediately receives 12‐month access to the web‐based intervention (Optimune). Measurements are collected at pre‐treatment (T0) three months (T1) and six months (T2).
Epistemonikos ID: b34edc98e0ffcb181db33e4a2763c34512be4c72
First added on: May 21, 2024