Study protocol of ConquerFear-HK: a randomised controlled trial of a metacognition-based, manualised intervention for fear of cancer recurrence among Chinese cancer survivors

Abstract

IntroductionFear of cancer recurrence (FCR) is a prevalent and frequently debilitating response to a cancer diagnosis, affecting a substantial proportion of cancer survivors. Approximately 30% of local Hong Kong Chinese cancer survivors in a recent survey reportedly experienced persistent high FCR over the first-year post-surgery. This was associated with lower levels of psychological well-being and quality of life. A manualised intervention (ConquerFear) developed primarily based on the Self-Regulatory Executive Function Model and the Rational Frame Theory, has been found to reduce FCR effectively among Caucasian cancer survivors. The intervention now has been adapted to a Chinese context; ConquerFear-HK. The primary aim of this study is to evaluate its efficacy vs a standard-survivorship-care control (BasicCancerCare) in FCR improvement in a randomised control trial (RCT).Methods and analysisIn this RCT, using the sealed envelope method, 174 eligible Chinese cancer survivors will be randomised to either the ConquerFear-HK or BasicCancerCare intervention. Both interventions include six sessions over 10 weeks, which will be delivered via face to face or online by trained therapists. The ConquerFear-HK intervention incorporates value classification, metacognitive therapy, attentional training, detached mindfulness and psychoeducation; BasicCancerCare includes relaxation training, dietary and physical activity consultations. Participants will be assessed at prior randomisation (baseline; T0), immediately postintervention (T1), 3 months (T2) and 6 months postintervention (T3) on the measures of FCR (Fear of Cancer Recurrence Inventory) as a primary outcome; metacognition (30-item Metacognitions Quesionnaire) and cognitive attentional syndrome (Cognitive-attentional Syndrome Questionnaire) as process outcomes; psychological distress (Hospital Anxiety and Depression Scale), cancer-related distress (Chinese Impact of Events Scale), quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire) and treatment satisfaction are secondary outcomes.Ethics and disseminationEthics approval has been obtained from HKU/HA HKW Institutional Review Board (ref: UW19-183). The patients/participants provide their written informed consent to participate in this study. The study results will be disseminated through international peer-review publications and conference presentations.Trial registration numberNCT04568226.

Validation of Shortened Forms of Metacognition Questionnaire-Insomnia and Its Feasibility in the Discrepancy-Cognitive Arousal Model of Insomnia Among Patients With Cancer

“…Their dysfunctional beliefs can influence their insomnia and even fear of disease progression [ 12 ]. Additionally, metacognition reportedly affects depression, anxiety [ 13 ], fear of progression [ 14 ], and even reproductive concerns [ 15 ] in patients with cancer; thus, we can speculate that metacognition on insomnia will also influence their insomnia or sleep disturbance. However, the role of metacognition on insomnia in patients with cancer is still unexplored.…”