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

Koo Foundation Sun Yat-Sen Cancer Center

Status: Not yet enrolling

Conditions: Cancer Survivors; Psychological Distress; Fear of Cancer Recurrence

Treatments: Behavioral: Metacognitive Therapy; Behavioral: Relaxation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07500168

20251030A

KFSYSCC IRB No. 20251030A (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Metacognitive Therapy (MCT) Group

Experimental group

Description:

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.

Treatment:

Behavioral: Metacognitive Therapy

Relaxation Therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Relaxation Therapy