Fear of Cancer RecurrenceMCT-FCRNCT07500168
Fighting the Fear of Cancer Recurrence in Cancer Survivors: A Pilot Study on the Effectiveness of Metacognitive Therapy
A study testing Metacognitive Therapy and Relaxation Therapy in people with Fear of Cancer Recurrence and Cancer Survivors, run by Koo Foundation Sun Yat-Sen Cancer Center at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fear of Cancer Recurrence, Cancer Survivors, Psychological Distress
- What is being tested?
- Metacognitive Therapy and Relaxation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals with severe psychiatric disorders.
- Individuals who have difficulty communicating in Mandarin. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taipei, 112
Chih-Tao Cheng, MD, PhD, +886-2-28970011 ext. 1643, chihtao@kfsyscc.org
Chia-Fang Chung, MSN, +886-2-28970011 ext. 3379, sandychung1979@kfsyscc.org
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Metacognitive Therapy, Relaxation Therapy
- Keywords
- Fear of Cancer Recurrence, Cancer Survivors, Psycho-oncology, ConquerFear, Randomized Controlled Trial, Anxiety, Depression, Quality of Life
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive TherapyBehavioural
Also called ConquerFear, MCT
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.
Relaxation TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Relaxation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 weeks (post-intervention), 3 months, and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startApr 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of Cancer RecurrenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koo Foundation Sun Yat-Sen Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chihtao Cheng, Koo Foundation Sun Yat-Sen Cancer Center
- Investigators
- Chih-Tao Cheng, MD, PhD, Principal investigator, Koo Foundation Sun Yat-Sen Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500168
- Sponsor's protocol ID
- 20251030A
- Other IDs
- KFSYSCC IRB No. 20251030A
- Acronym
- MCT-FCR
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality concerns.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fighting the Fear of Cancer Recurrence in Cancer Survivors: A Pilot Study on the Effectiveness of Metacognitive Therapy
- ClinicalTrials.gov ID
- NCT07500168
- Acronym / sponsor ID
- MCT-FCR / 20251030A
- Keywords
- Fear of Cancer Recurrence, Cancer Survivors, Psycho-oncology, ConquerFear, Randomized Controlled Trial, Anxiety, Depression, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Koo Foundation Sun Yat-Sen Cancer CenterUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Therapy (MCT) Group | Experimental | Behavioral: Metacognitive TherapyParticipants 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. |
| Relaxation Therapy | Active comparator | Behavioral: Relaxation TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals with severe psychiatric disorders.
- Individuals who have difficulty communicating in Mandarin. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive TherapyAlso: ConquerFear, MCTA 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. | Behavioural | Metacognitive Therapy (MCT) Group |
| Relaxation TherapyA 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. | Behavioural | Relaxation Therapy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality concerns.
Related trials for Fear of Cancer Recurrence
Not yet recruitingPhase 2
Psilocybin FCR Early-Stage Breast Cancer
Early-stage Breast Cancer, Fear of Cancer Recurrence
RecruitingPhase 1
Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence
Breast Cancer, Ovarian Cancer
Recruiting
The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence
Cancer, Fear of Cancer Recurrence
Recruiting
Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program
Fear of Cancer Recurrence, Cancer
Not yet recruiting
Acceptance and Commitment Therapy (ACT) Versus Cognitive Behavioural Therapy (CBT) for Fear of Cancer Recurrence (FCR) in Cancer Survivors and Their Spouses
Fear of Cancer Recurrence, Cancer Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chih-Tao Cheng, MD, PhD principal investigator
Koo Foundation Sun Yat-Sen Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Therapy and Relaxation Therapy in people with Fear of Cancer Recurrence and Cancer Survivors, run by Koo Foundation Sun Yat-Sen Cancer Center at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Tao Cheng, MD, PhD (+886-2-28970011 ext. 1643, chihtao@kfsyscc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Cancer Recurrence (time frame: Baseline to 6 weeks (post-intervention), 3 months, and 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.