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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fear of Cancer Recurrence

Intervention / Treatment
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* Behavioral: Fear-focused Self-Compassion Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fear-focused Self-Compassion Therapy<br>Experimental group receives group face-to-face Fear-focused Self-Compassion Therapy for eight weeks. | Behavioral: Fear-focused Self-Compassion Therapy<br>* The Fear-focused Self-Compassion Therapy will be delivered as a group format. The intervention consists of eight group face-to-face sessions (60-90 minute for each session) and will be delivered by three trained therapists for eight weeks (sessions are weekly). Each intervention group involves 10 patients.<br>|
| No Intervention: Usual care<br>The no intervention group receives usual care supported by hospital or coming from elsewhere for eight weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of cancer recurrence (FCR) | 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. | Baseline | 
| Change from Baseline Fear of cancer recurrence (FCR) 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. | After immediately completing intervention | 
| Change from Baseline Fear of cancer recurrence (FCR) at 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. | Baseline to 3 months | 
| Change from Baseline Fear of cancer recurrence (FCR) at 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. | Baseline to 6 months | 
| Change from Baseline Fear of cancer recurrence (FCR) at 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. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-compassion | Self-compassion will be measured by using the 12-item Self-compassion Scale-Short Form (SCS-SF) consisting of six facets: self-kindness (2 items), self-judgement (2 items), common humanity (2 items), isolation (2 items), mindfulness (2 items) and over-identification (2 items) . Responses were rated on a five-point scale from 1 (almost never) to 5 (almost always). | Baseline, immediately completing intervention, baseline to 3 months, baseline to 6 months, baseline to 12 months. | 
| Salivary alpha amylase | The salivary alpha amylase activity will be measured by using a hand-held salivary alpha amylase monitor manufactured by Nipro (Osaka, Japan). This analyzer can automatically measure the salivary alpha amylase activity within one minute (about 30 seconds for saliva collection and 30 seconds for analyzing). Participants will be asked to brush teeth before measurement and not allowed to intake any food, beverage, tobacco or liquor within an hour. | Baseline and immediately completing intervention | 
| Heart rate variability (HRV) | The HRV will be measured by using signal detection and amplification system (Biopac ECG100C) of MP150-Biopac data acquisition system. The CardioBatch will be used to compute the HRV. Participants will be asked not to intake any stimulant (e.g., caffein, alcohol), or cannot do any strenuous activity within four hours before measurement. | Baseline and immediately completing intervention | 
| Attentional bias for FCR | Attentional bias for FCR will be assessed by conducting the dot-probe task, including 200 trials with the stimuli of cancer-related words and utilized in previous study. The dot-probe task will be presented on a laptop computer and run by using Matlab. At the beginning of each trial, a + will present for 500 milliseconds in the center of the screen. After that, a pair of word stimuli with a neutral word (e.g., apple) and a cancer-related word (e.g., chemotherapy) will be presented for 500 milliseconds on the left and right sides of screen. Then, the probe stimuli will be presented at the position where the word stimuli just appear. Once the probe stimuli appear, participants should press button of the keyboard as soon as possible. After that, the screen will present 500 milliseconds of blanking, and the next trial will start. | Baseline and immediately completing intervention | 
| Rumination | Rumination will be measured by using the 4-item Cognitive Emotion Regulation Questionnaire Rumination Subscale (CERQ-RS). Each item of CERQ-RS ranges from 1 to 5. A higher total score means more severe rumination. | Baseline and immediately completing intervention | 
| Catastrophizing thinking | Catastrophizing thinking will be measured by using the 4-item Cognitive Emotion Regulation Questionnaire Catastrophizing Subscale (CERQ-CS). Each item of CERQ-CS ranges from 1 to 5. A higher total score means more severe catastrophizing thinking. | Baseline and immediately completing intervention | 
| Psychological symptoms | Psychological symptoms will be measured by using Hospital Anxiety and Depression Scale (HADS). This 9-item questionnaire consisting of both anxiety subscale and depression subscale, rates on five-point (0-4) scales. The total score ranges from 0 to 36, and a higher total score means more severe depression and anxiety symptoms. | Baseline, immediately completing intervention, baseline to 3 months, baseline to 6 months, baseline to 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fear of Cancer Recurrence, Self-compassion Therapy, RCT