Fear-focused Self-Compassion Therapy for Young Breast Cancer Patients' Fear of Cancer Recurrence

Fear-focused Self-Compassion Therapy for Young Breast Cancer Patients' Fear of Cancer Recurrence: Study Protocol of a Randomized Controlled Trial

Few studies have tailored psychological intervention for fear of cancer recurrence (FCR) in young breast cancer patients, and the long-term efficacy of psychological intervention and its underlying mechanism are still unknown. To fill this knowledge gap, this protocol aims to evaluate the short-term and long-term effectiveness of Fear-focused Self-Compassion Therapy, as well as this therapy's psychological and physiological mechanisms in reducing severe FCR in young women with breast cancer.

This study will be a randomized controlled trial recruiting 160 Chinese young female breast cancer patients with severe FCR. Participants will be randomized to the Fear-focused Self-Compassion Therapy group or control group (1:1). Measurement will be completed at baseline (T0), immediately completing intervention (T1), after 3 months (T2), after 6 months (T3) and after 12 months (T4). Primary outcomes are FCR severity; secondary outcomes are self-compassion, neurophysiological data (i.e., salivary alpha amylase and heart rate variability), attentional bias for FCR, rumination, catastrophizing thinking, and psychological symptoms. The Fear-focused Self-Compassion Therapy is based on the theories of FCR development and self-compassion, and consists of eight-week face to face group sessions.

Inclusion Criteria:

• (1) are diagnosed with breast cancer (including various cancer stages and subtypes);
• (2) are aged 18-45 years;
• (3) can sign written informed consent;
• (4) can read and write Chinese;
• (5) have severe FCR, with scores > 13 on the FCRI severity subscale.

Exclusion Criteria:

• (1) currently have psychiatric and psychological illness;
• (2) have other types of tumor;
• (3) had a previous cancer recurrence;
• (4) are participating another psychological intervention at the start of the study or during their eight-week therapy.