Fear of Cacer Recurrence in Cancer SurvivorwsMHPIINCT07542821
Cancer Survivors' Fear of Cancer Recurrence
A study testing psycological cognitive training, Healthy lifestyle and education in people with Fear of Cacer Recurrence in Cancer Survivorws, run by National Taipei University of Nursing and Health Sciences.
Trial summary
The purpose of this study is to develop and evaluate the tailored support for the fear of cancer recurrence in breast, head and neck, colon-rectal or prostate cancer survivors. Based on screening for fear of cancer recurrence, different levels of supportive care will be provided, starting with the oncology nurses'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fear of Cacer Recurrence in Cancer Survivorws
- What is being tested?
- psycological cognitive training, Healthy lifestyle and education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 30 Nov 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
- stage I, II, III breast, head and neck, colo-rectal, proste cancer and completion of primary cancer treatment
- report of fear of cancer recurrence
- able to read and listen in Manderin and without a cognitive defect
Who cannot join
- diagnosed with severe mental illness
- difficult to communicate in Manderin
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development and Evaluation of An Innovative Program in Mental Health Promotion
The purpose of this study is to develop and evaluate the tailored support for the fear of cancer recurrence in breast, head and neck, colon-rectal or prostate cancer survivors. Based on screening for fear of cancer recurrence, different levels of supportive care will be provided, starting with the oncology nurses' health education and information for those having a lower level of concern. Those who have medium or higher levels of concerns will be randomized to receive "stepping up" either a "ConquerFear psychological cognitive training" or a "healthy lifestyle - individualized exercise and nutrition guidance".
- Being tested
- psycological cognitive training, Healthy lifestyle, education
- Keywords
- Fear of cancer recurrence, cancer survivor, psychosoical support, ConquerFear, Healthy life style
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psycological cognitive trainingBehavioural
Also called ConquerFear
Metacognition
Healthy lifestyleBehavioural
Also called nutrition counseling, excercise training
individualized nutrition and exercise guidance
educationBehavioural
FCR education
| Study group | Role | What they receive |
|---|---|---|
| education group | Active comparator | one session of nurses' education and information Receives: Behavioral: education |
| ConquerFear group | Experimental | a 6-session add-on psychological cognitive training performed by a trained psychologist Receives: Behavioral: psycological cognitive training; Behavioral: education |
| Healthy lifestyle group | Experimental | a 6-session add-on individualized nutrition and exercise guidance performed by a trained nutritionist and an exercise expert. Receives: Behavioral: Healthy lifestyle; Behavioral: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Cance Recurrence
the change of FCR (Fear of Cancer Recurrence) score as measured by FCRI
Measured: From the baseline to the 3 months after intervention at 5 months
Secondary outcomes (2)
Psychological distress
the change of the anxiety and depression as measured by HADS
Measured: From the baseline to the 3 months after intervention at 5 months
QOL
The change of the quality of life score as measured by VR-12
Measured: From the baseline to the 3 months after intervention at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fear of Cacer Recurrence in Cancer SurvivorwsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Based on screening levels of fear of cancer recurrence (FCR), those with lower FCR will receive only education, and those with medium or higher FCR will be randomized to one of two add-on psychological cognitive training or individualized healthy lifestyle guidance groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan, Koo Foundation Sun Yat-Sen Cancer Center
- Responsible party
- Principal investigator, Shiuyu Katie Lee,RN MSN PhD, National Taipei University of Nursing and Health Sciences
- Investigators
- Shiuyu C. Katie Lee, PhD, Principal investigator, National Taipei University of Nursing and Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542821
- Sponsor's protocol ID
- NTUNHS114G010
- Acronym
- MHPII
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is restricted by the sponsors.
Publications
Park SY, Lim JW. Cognitive behavioral therapy for reducing fear of cancer recurrence (FCR) among breast cancer survivors: a systematic review of the literature. BMC Cancer. 2022 Feb 28;22(1):217. doi: 10.1186/s12885-021-08909-y.
PubMed 35227244Ng DWL, Ng R, Guo C, Chan J, Fielding R, Tang JWC, Li WWY, Foo CC, Kwong A, Ng SS, Suen D, Fung S, Chun OK, Chan KKL, Chang ATY, Butow P, Lam WWT. ConquerFear-HK: A Randomized Controlled Trial of a Metacognition-Based, Manualized Intervention for Fear of Cancer Recurrence among Chinese Cancer Survivors. Psychother Psychosom. 2026;95(2):117-133. doi: 10.1159/000547888. Epub 2025 Aug 8.
PubMed 40784346
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of An Innovative Program in Mental Health Promotion
- ClinicalTrials.gov ID
- NCT07542821
- Acronym / sponsor ID
- MHPII / NTUNHS114G010
- Keywords
- Fear of cancer recurrence, cancer survivor, psychosoical support, ConquerFear, Healthy life style
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan, Koo Foundation Sun Yat-Sen Cancer Center
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 21 Apr 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.
The purpose of this study is to develop and evaluate the tailored support for the fear of cancer recurrence in breast, head and neck, colon-rectal or prostate cancer survivors. Based on screening for fear of cancer recurrence, different levels of supportive care will be provided, starting with the oncology nurses' health education and information for those having a lower level of concern. Those who have medium or higher levels of concerns will be randomized to receive "stepping up" either a "ConquerFear psychological cognitive training" or a "healthy lifestyle - individualized exercise and nutrition guidance".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Based on screening levels of fear of cancer recurrence (FCR), those with lower FCR will receive only education, and those with medium or higher FCR will be randomized to one of two add-on psychological cognitive training or individualized healthy lifestyle guidance groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| education group | Active comparator | Behavioral: educationone session of nurses' education and information |
| ConquerFear group | Experimental | Behavioral: psycological cognitive training, Behavioral: educationa 6-session add-on psychological cognitive training performed by a trained psychologist |
| Healthy lifestyle group | Experimental | Behavioral: Healthy lifestyle, Behavioral: educationa 6-session add-on individualized nutrition and exercise guidance performed by a trained nutritionist and an exercise expert. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stage I, II, III breast, head and neck, colo-rectal, proste cancer and completion of primary cancer treatment
- report of fear of cancer recurrence
- able to read and listen in Manderin and without a cognitive defect
Key exclusion criteria (2 listed)
- diagnosed with severe mental illness
- difficult to communicate in Manderin
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 |
|---|---|---|
| psycological cognitive trainingAlso: ConquerFearMetacognition | Behavioural | ConquerFear group |
| Healthy lifestyleAlso: nutrition counseling, excercise trainingindividualized nutrition and exercise guidance | Behavioural | Healthy lifestyle group |
| educationFCR education | Behavioural | ConquerFear group, Healthy lifestyle group, education group |
Primary outcome
Fear of Cance Recurrence
Time frame: From the baseline to the 3 months after intervention at 5 months
the change of FCR (Fear of Cancer Recurrence) score as measured by FCRI
2 secondary outcomes
Psychological distress
Time frame: From the baseline to the 3 months after intervention at 5 months
QOL
Time frame: From the baseline to the 3 months after intervention at 5 months
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 21 Apr 2026.
- Background: PubMed 35227244Park SY, Lim JW. Cognitive behavioral therapy for reducing fear of cancer recurrence (FCR) among breast cancer survivors: a systematic review of the literature. BMC Cancer. 2022 Feb 28;22(1):217. doi: 10.1186/s12885-021-08909-y.
- Background: PubMed 40784346Ng DWL, Ng R, Guo C, Chan J, Fielding R, Tang JWC, Li WWY, Foo CC, Kwong A, Ng SS, Suen D, Fung S, Chun OK, Chan KKL, Chang ATY, Butow P, Lam WWT. ConquerFear-HK: A Randomized Controlled Trial of a Metacognition-Based, Manualized Intervention for Fear of Cancer Recurrence among Chinese Cancer Survivors. Psychother Psychosom. 2026;95(2):117-133. doi: 10.1159/000547888. Epub 2025 Aug 8.
- Individual participant dataSharing planned: No. It is restricted by the sponsors.
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.
Shiuyu C. Katie Lee, PhD principal investigator
National Taipei University of Nursing and Health Science
Questions about this trial
What is this clinical trial studying?
A study testing psycological cognitive training, Healthy lifestyle and education in people with Fear of Cacer Recurrence in Cancer Survivorws, run by National Taipei University of Nursing and Health Sciences.
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 3 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Shiuyu C. Katie Lee (886961395150, shiuyu@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Cance Recurrence (time frame: From the baseline to the 3 months after intervention at 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07542821, which also lists 2 linked publications.
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 21 Apr 2026.