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

Fear of Cancer Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04965428
• Other study ID #: Self-compassion FCR
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Shaanxi Normal University
• Contact: Lei Zhu, PhD
• Phone: +8615091199645
• Email: lei.zhu[@]snnu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fear of Cancer Recurrence
• Recurrence

Intervention

Behavioral:
• Fear-focused Self-Compassion Therapy
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.

Locations

Country	Name	City	State
China	Shaanxi Provincial Cancer Hospital	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Shaanxi Normal University	Shaanxi Provincial Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.