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

  • STATUS
    Recruiting
  • days left to enroll
    69
  • participants needed
    160
  • sponsor
    School of Psychology, Shaanxi Normal University
Updated on 4 October 2021

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.

Details
Condition Fear of Cancer Recurrence
Treatment Fear-focused Self-Compassion Therapy
Clinical Study IdentifierNCT04965428
SponsorSchool of Psychology, Shaanxi Normal University
Last Modified on4 October 2021

Eligibility

Yes No Not Sure

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
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