Fighting the Fear of Cancer Recurrence in Cancer Survivors: A Pilot Study on the Effectiveness of Metacognitive Therapy (MCT-FCR)

March 24, 2026 updated by: Chihtao Cheng, Koo Foundation Sun Yat-Sen Cancer Center

This study aims to evaluate the effectiveness of metacognitive therapy (MCT) in reducing fear of cancer recurrence (FCR) among cancer survivors.

With advances in cancer treatment, more patients are surviving cancer. However, many survivors continue to experience fear of cancer recurrence, which can affect their emotional well-being, quality of life, and ability to return to normal daily activities.

In this study, participants will receive a structured psychological intervention adapted from the ConquerFear program. This program has been modified to better fit local cultural needs.

Participants will be randomly assigned to receive either metacognitive therapy or relaxation therapy.

The study will compare the effects of these interventions on reducing fear of cancer recurrence, as well as their impact on emotional distress and quality of life.

The results of this study may help develop effective psychological treatments to support cancer survivors in managing fear of recurrence and improving overall well-being.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cancer has been the leading cause of death in Taiwan since 1982. The World Health Organization emphasizes that psychological and social care are as important as medical treatment in cancer care. Cancer patients experience multidimensional stress, including physical, psychological, and existential challenges, often accompanied by symptoms such as pain, anxiety, depression, insomnia, hopelessness, and fear of death.

Advances in cancer treatment, including early detection, precision medicine, immunotherapy, and targeted therapy, have significantly improved survival rates. However, cancer survivors frequently experience ongoing physical, psychological, and social challenges.

Fear of cancer recurrence (FCR) is one of the most prevalent and clinically significant concerns among cancer survivors, with prevalence rates ranging from 22% to 87% (Simard et al., 2013). Excessive FCR is associated with increased anxiety and depression, and may interfere with return to work and normal daily functioning.

FCR has become a major focus in psycho-oncology worldwide, as it significantly affects psychological well-being, quality of life, and health-related behaviors among cancer survivors.

This study aims to evaluate the effectiveness of metacognitive therapy (MCT) in reducing FCR among cancer survivors. MCT targets maladaptive metacognitive processes such as worry and rumination, which are central to the maintenance of emotional distress.

The intervention is adapted from the Hong Kong version of the ConquerFear program and culturally modified for local use.

A randomized controlled design will be used to compare the effectiveness of the adapted ConquerFear intervention with a relaxation therapy control condition in reducing FCR.

In addition, the study will explore whether coping styles moderate the effectiveness of the intervention.

The findings of this study are expected to provide evidence for developing effective psychological interventions to improve mental health outcomes in cancer survivors.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • Taipei
      • Taipei, Taipei, Taiwan, 112
        • Koo Foundation Sun Yat-Sen Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chih-Tao Cheng, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 years or older.
  2. Patients with cancer classified as stage I, II, or III according to the TNM staging system who have completed primary cancer treatment.
  3. Ability to understand and read Chinese, with no significant cognitive impairment.
  4. A score of 13 or higher on a validated measure of fear of cancer recurrence.

Exclusion Criteria:

  1. Individuals with severe psychiatric disorders.
  2. Individuals who have difficulty communicating in Mandarin. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metacognitive Therapy (MCT) Group
Participants in this group will receive a structured metacognitive therapy (MCT) intervention adapted from the ConquerFear program. The intervention is designed to reduce fear of cancer recurrence by targeting maladaptive metacognitive processes such as worry and rumination. The therapy will be delivered over a defined treatment period.
Behavioral: Metacognitive Therapy
A structured psychological intervention targeting maladaptive metacognitive beliefs and processes, such as worry and rumination. This intervention is adapted from the ConquerFear program and aims to reduce fear of cancer recurrence among cancer survivors.
Other Names:
  • MCT
  • ConquerFear
Active Comparator: Relaxation Therapy
Participants in this group will receive relaxation therapy as a control condition. The intervention includes relaxation techniques aimed at reducing stress and emotional distress. This group serves as an active comparator to evaluate the effectiveness of metacognitive therapy in reducing fear of cancer recurrence.
Behavioral: Relaxation Therapy
A psychological intervention involving relaxation techniques, such as breathing exercises and muscle relaxation, aimed at reducing stress and emotional distress. This intervention is used as an active comparator to compare its effectiveness with metacognitive therapy in reducing fear of cancer recurrence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of Cancer Recurrence
Time Frame: Baseline to 6 weeks (post-intervention), 3 months, and 6 months follow-up
Fear of cancer recurrence will be assessed using a validated self-report questionnaire to evaluate the severity of fear and related psychological distress among cancer survivors.
Baseline to 6 weeks (post-intervention), 3 months, and 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koo Foundation Sun Yat-Sen Cancer Center

Investigators

  • Principal Investigator: Chih-Tao Cheng, MD, PhD, Koo Foundation Sun Yat-Sen Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20251030A
  • KFSYSCC IRB No. 20251030A (Other Identifier: KFSYSCC Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy and confidentiality concerns.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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