Fighting the Fear of Cancer Recurrence in Cancer Survivors: A Pilot Study on the Effectiveness of Metacognitive Therapy

NCT07500168 | Not Yet Recruiting

• 2 other identifiers: 20251030AKFSYSCC IRB No. 20251030A
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fear of Cancer Recurrence; Cancer Survivors; Psychological Distress

Keywords

Fear of Cancer Recurrence; Cancer Survivors; Psycho-oncology; ConquerFear; Randomized Controlled Trial; Anxiety; Depression; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Fear of Cancer Recurrence

  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

Study Arms (2)

Metacognitive Therapy (MCT) Group

EXPERIMENTAL

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

Relaxation Therapy

ACTIVE COMPARATOR

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

Interventions

Metacognitive Therapy BEHAVIORAL

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.

Also known as: ConquerFear, MCT

Metacognitive Therapy (MCT) Group

Relaxation Therapy BEHAVIORAL

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.

Relaxation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Koo Foundation Sun Yat-Sen Cancer Center: lead

Study Sites (1)

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Chih-Tao Cheng, MD, PhD

  Koo Foundation Sun Yat-Sen Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih-Tao Cheng, MD, PhD

CONTACT

+886-2-28970011; chihtao@kfsyscc.org

Chia-Fang Chung, MSN

CONTACT

+886-2-28970011; sandychung1979@kfsyscc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Psychiatry

Model Details: Participants will be randomly assigned to one of two parallel groups: a metacognitive therapy (MCT)-based intervention adapted from the ConquerFear program, or a relaxation therapy control condition. Both interventions will be delivered over a defined treatment period. Outcomes will be assessed at baseline and post-intervention to evaluate changes in fear of cancer recurrence and related psychological outcomes.

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)