Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fear of Cancer Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fear-focused Self-Compassion Therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fear-focused Self-Compassion Therapy
- description
- Experimental group receives group face-to-face Fear-focused Self-Compassion Therapy for eight weeks.
- interventionNames
- Behavioral: Fear-focused Self-Compassion Therapy
- type
- NO_INTERVENTION
- label
- Usual care
- description
- The no intervention group receives usual care supported by hospital or coming from elsewhere for eight weeks.
Primary outcomes (5)
- measure
- Fear of cancer recurrence (FCR)
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWei L, Yang X, Sun S, Yu Y, Xie J, Zhao J, Wang X, Zhu L, Yao J. Fear-focused Self-compassion Therapy for young breast cancer patients' fear of cancer recurrence: Study protocol of a randomized controlled trial. Front Psychiatry. 2022 Sep 23;13:941459. doi: 10.3389/fpsyt.2022.941459. eCollection 2022. PMID 36213912