Clinical trial NCT04965428: Fear-focused Self-Compassion Therapy for Young Breast Cancer Patients' Fear of Cancer Recurrence
Official title: Fear-focused Self-Compassion Therapy for Young Breast Cancer Patients' Fear of Cancer Recurrence: Study Protocol of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fear of Cancer Recurrence
Keywords: Fear of Cancer Recurrence
Self-compassion Therapy
RCT
Lead sponsor: Shaanxi Normal University
Sponsor class: OTHER
Collaborators: name: Shanxi Provincial Cancer Hospital
First posted: 2021-07-16
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fear of cancer recurrence (FCR)
timeFrame: Baseline
measure: Change from Baseline Fear of cancer recurrence (FCR) after immediately completing intervention
timeFrame: After immediately completing intervention
measure: Change from Baseline Fear of cancer recurrence (FCR) at 3 months
timeFrame: Baseline to 3 months
measure: Change from Baseline Fear of cancer recurrence (FCR) at 6 months
timeFrame: Baseline to 6 months
measure: Change from Baseline Fear of cancer recurrence (FCR) at 12 months
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Self-compassion
timeFrame: Baseline, immediately completing intervention, baseline to 3 months, baseline to 6 months, baseline to 12 months.
measure: Salivary alpha amylase
timeFrame: Baseline and immediately completing intervention
measure: Heart rate variability (HRV)
timeFrame: Baseline and immediately completing intervention
measure: Attentional bias for FCR
timeFrame: Baseline and immediately completing intervention
measure: Rumination
timeFrame: Baseline and immediately completing intervention
measure: Catastrophizing thinking
timeFrame: Baseline and immediately completing intervention
measure: Psychological symptoms
timeFrame: Baseline, immediately completing intervention, baseline to 3 months, baseline to 6 months, baseline to 12 months.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Shaanxi Provincial Cancer Hospital
state: Shaanxi
Study officials:
affiliation: Shaanxi Normal University
name: Lei Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanxi Provincial Cancer Hospital
name: Juntao Yao, PhD
role: STUDY_DIRECTOR
References:
citation: Wei 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.