A Protocol for a feasibility study of Cognitive Bias Modification training (IVY 2.0) countering fatigue in people with breast cancer

Abstract

Background Cancer related fatigue (CRF) is the most prevalent, distressing and quality of life disturbing symptom during and after cancer treatment for many cancer types including breast cancer. The experience and burden of this symptom can induce a cognitive bias towards fatigue or a fatigue related self-image, which can further increase the fatigue symptoms and related behaviour. For this, a Cognitive Bias Modification (CBM) eHealth app (IVY 2.0) has been developed. The app aims to counter the fatigue related self-image and to modify it towards vitality, which might translate to less experienced fatigue and more experienced vitality. This study aims to evaluate the feasibility and effectiveness of the IVY 2.0 CBM training in a feasibility wait-list control trial. The effectiveness of the CBM app is measured on (1) underlying mechanisms (cognitive fatigue bias), (2) symptom fatigue (self-reported fatigue and vitality), and (3) related behaviours (avoidance and all-or-nothing behaviour). Methods This feasibility study addresses individuals being treated for breast cancer receiving (neo)adjuvant treatment as well as people in the metastatic phase. The number of target participants is 120 with 60 people in the (neo)adjuvant setting, and 60 in the metastatic setting, both groups divided 1:1 with 30 people in the IVY treatment group and 30 people in the delayed treatment control group. All participants receive the training via the IVY 2.0 app, in which participants categorize words related to vitality with words related to ‘I’ and words related to fatigue with words related to ‘other’. Preliminary effects are measured on 3 levels; (1) self-identity bias is measured with a short computer task based on the Implicit Association Test (IAT), while (2) avoidance and all-or-nothing behaviour, as well as (3) fatigue and vitality levels are measured with questionnaires. Discussion This study wants to evaluate the feasibility of a larger-scale multi-centre RCT to investigate this novel eHealth application and to give first indications on the effectiveness of this intervention to counter fatigue in people suffering from breast cancer. Using the IVY 2.0 CBM app requires very little effort, both in time and cognitive load, which could be especially beneficial for fatigue symptoms. Trial registration: Retrospectively registered at the Open Science Framework (OSF; https://osf.io/e85g7/) on October 20, 2023.