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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-12-31

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.

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Detailed Description

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Conditions

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Fear of Cancer Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fear-focused Self-Compassion Therapy

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

Group Type EXPERIMENTAL

Fear-focused Self-Compassion Therapy

Intervention Type 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.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No