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NCT Number: NCT07500168

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Other names: ConquerFear, MCT

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chia-Fang Chung, MSN

CONTACT

[email protected]

+886-2-28970011 ext. 3379

Chih-Tao Cheng, MD, PhD

CONTACT

[email protected]

+886-2-28970011 ext. 1643

Sponsors and collaborators

Lead sponsor

Koo Foundation Sun Yat-Sen Cancer Center

Other

Registry information

Acronym: MCT-FCR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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