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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07500168
Acronym
MCT-FCR
Enrollment
120
Registered
2026-03-30
Start date
2026-04-01
Completion date
2028-12-31
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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.

Interventions

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.

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.

Sponsors

Koo Foundation Sun Yat-Sen Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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. -

Design outcomes

Primary

MeasureTime frameDescription
Fear of Cancer RecurrenceBaseline to 6 weeks (post-intervention), 3 months, and 6 months follow-upFear 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.

Countries

Taiwan

Contacts

CONTACTChih-Tao Cheng, MD, PhD
chihtao@kfsyscc.org+886-2-28970011
CONTACTChia-Fang Chung, MSN
sandychung1979@kfsyscc.org+886-2-28970011
PRINCIPAL_INVESTIGATORChih-Tao Cheng, MD, PhD

Koo Foundation Sun Yat-Sen Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026