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

NCT04965428 | Unknown

• 1 other identifier: Self-compassion FCR
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Fear of Cancer Recurrence

Keywords

Fear of Cancer Recurrence; Self-compassion Therapy; RCT

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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

Study Arms (2)

Fear-focused Self-Compassion Therapy

EXPERIMENTAL

Experimental group receives group face-to-face Fear-focused Self-Compassion Therapy for eight weeks.

Behavioral: Fear-focused Self-Compassion Therapy

Usual care

NO INTERVENTION

The no intervention group receives usual care supported by hospital or coming from elsewhere for eight weeks.

Interventions

Fear-focused Self-Compassion Therapy BEHAVIORAL

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.

Fear-focused Self-Compassion Therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Shaanxi Normal University: lead
• Shaanxi Provincial Cancer Hospital: collaborator

Study Sites (1)

Shaanxi Provincial Cancer Hospital

Xi'an, Shaanxi, 710000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 36213912 DERIVED

Study Officials

• Lei Zhu, PhD

  Shaanxi Normal University

  PRINCIPAL INVESTIGATOR

• Juntao Yao, PhD

  Shaanxi Provincial Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Lei Zhu, PhD

CONTACT

+8615091199645; lei.zhu@snnu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: July 16, 2021
• Study Start: September 15, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

CN (1)