Fear-focused Self-Compassion Therapy for Young Breast Cancer Patients' Fear of Cancer Recurrence: Study Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Fear of cancer recurrence (FCR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(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.
结局指标
主要结局
Fear of cancer recurrence (FCR)
时间窗: Baseline
Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.
Change from Baseline Fear of cancer recurrence (FCR) after immediately completing intervention
时间窗: After immediately completing intervention
Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.
Change from Baseline Fear of cancer recurrence (FCR) at 3 months
时间窗: Baseline to 3 months
Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.
Change from Baseline Fear of cancer recurrence (FCR) at 6 months
时间窗: Baseline to 6 months
Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.
Change from Baseline Fear of cancer recurrence (FCR) at 12 months
时间窗: Baseline to 12 months
Fear of cancer recurrence will be assessed using 42-item Fear of Cancer Recurrence Inventory (FCRI). This questionnaire consists of seven subscales, with a total score representing one's levels of FCR. A score of 13 or higher on 9-item severe subscale (ranges from 0-36) indicates a clinical FCR.
次要结局
- Self-compassion(Baseline, immediately completing intervention, baseline to 3 months, baseline to 6 months, baseline to 12 months.)
- Salivary alpha amylase(Baseline and immediately completing intervention)
- Heart rate variability (HRV)(Baseline and immediately completing intervention)
- Attentional bias for FCR(Baseline and immediately completing intervention)
- Rumination(Baseline and immediately completing intervention)
- Catastrophizing thinking(Baseline and immediately completing intervention)
- Psychological symptoms(Baseline, immediately completing intervention, baseline to 3 months, baseline to 6 months, baseline to 12 months.)
研究者
Lei, Zhu
Associate Professor
Shaanxi Normal University