CancerNCT06181331
The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence
A study testing eConquerFear, eHealthMaintenance and ConquerFear in people with Cancer and Fear of Cancer Recurrence, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
A sequential multiple-assignment randomized controlled trial (SMART) will be used to assess the effect of an adaptive stepped-care intervention on FCR in cancer survivors with subclinical levels of fear of cancer recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Fear of Cancer Recurrence
- What is being tested?
- eConquerFear, eHealthMaintenance and ConquerFear
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Feb 2026to 31 Dec 2027
- 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
- Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynecological cancer, who had completed treatment (except endocrine therapy) within five years, and with a Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) score of 13 to 21 indicating subclinical FCR will be included.
Who cannot join
- Patients with metastatic cancer, with a current diagnosis of depression or psychosis, or who are already receiving psychological treatment will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
QMh department of surgery
Hong Kong
CC Foo, 85222554389, ccfoo@hku.hk
About this study
Official title: The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence: Sequential, Multiple Assignment, Randomized Controlled Trial (SMARTs)
A sequential multiple-assignment randomized controlled trial (SMART) will be used to assess the effect of an adaptive stepped-care intervention on FCR in cancer survivors with subclinical levels of fear of cancer recurrence.
Read the detailed description
The current SMART trial aims to address the following research questions and hypotheses:
- What is the best initial low-intensity unsupervised self-guided e-intervention for managing subclinical FCR? Hypothesis 1: It is better to begin adaptive interventions with eConquerFear than with eHealthMaintenance. This hypothesis will address the main effect of the first-stage intervention.
- What is the best treatment option for non-respondents to initial adaptive interventions? Hypothesis 2: Among initial non-respondents, it is better to switch to supervised, individual, face-to-face ConquerFear than to group-delivered ConquerFear. This hypothesis will address the main effect of the second-stage intervention.
- Which of the four embedded adaptive interventions (1. eConquerFear + group-delivered ConquerFear; 2. eConquerFear + Individual ConquerFear; 3. eHealthMaintenance + group-delivered ConqerFear; 4. eHealthMaintenance + Individual ConquerFear) leads to the greatest reduction in FCR? Hypothesis 3: eConquerFear + Individual ConquerFear will lead to the greatest reduction in FCR. This hypothesis will identify the best adaptive intervention.
- Given that the ConquerFear intervention aims to modify unhelpful metacognitive beliefs and cognitive-attentional syndrome (CAS), we will test if the effect of stepped-care ConquerFear intervention on FCR is mediated by its effect on maladaptive metacognition and CAS. We hypothesize that there would be an indirect effect of stepped-care ConquerFear intervention on FCR through its effect on maladaptive metacognition and CAS (Hypothesis 4).
- Conditions
- Cancer, Fear of Cancer Recurrence
- Being tested
- eConquerFear, eHealthMaintenance, ConquerFear, Group-delivered ConquerFear-HK
- Keywords
- Sequential multiple assessment randomized controlled trial, stepped-up care, psychooncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eConquerFearBehavioural
The key goals of this e-intervention are to: (i) teach strategies for controlling worry and excessive threat monitoring; (ii) modify underlying unhelpful MCQ beliefs about worry; (iii) develop appropriate monitoring and screening behaviours, (iv) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (v) clarify values and encourage engagement in values-based goal setting.
eHealthMaintenanceBehavioural
eHealthMaintenance is not developed specifically to target fear of cancer recurrence through modifying participants' cognitive beliefs. Participants in this arm will receive 6 videos about relaxation, generic dietary and exercise knowledge.
ConquerFearBehavioural
ConquerFear is an intensive version of eConquerFear, which consists of 6 face-to-face therapist-led sessions.
Group-delivered ConquerFear-HKBehavioural
Group-delivered ConquerFear-HK is a manualized six-session intervention over 10 weeks. The key goals of the intervention are identical to the individual-based ConquerFear manualized intervention.
| Study group | Role | What they receive |
|---|---|---|
| First stage intervention: eConquerFear | Experimental | Participants in the eConquerFear intervention group will receive six online modules with each containing educational text, illustrative graphics, interactive exercises, and brief videos. Every module will teach a specific topic, such as self-examination and medical surveillance, values-based goal setting, attention training, detached mindfulness, worry management and treatment summary and relapse prevention. Receives: Behavioral: eConquerFear |
| First stage intervention: eHealthMaintenance | Active comparator | Participants in the eHealthMaintenance group will receive six videos, which were designed to provide comprehensive lifestyle guidance (e.g., relaxation techniques, diet and physical activity advices) to help with survivors' maintenance of health in long-term. Receives: Behavioral: eHealthMaintenance |
| Second stage intervention: ConquerFear-HK | Experimental | ConquerFear-HK is a culturally adapted, manualized intervention consisting of 6 individual face-to-face sessions over 10 weeks. Receives: Behavioral: ConquerFear |
| Second stage intervention: Group-delivered ConquerFear-HK | Active comparator | Group-delivered ConquerFear-HK is a manualized six-session intervention over 10 weeks. The key goals of the intervention are identical to the individual-based ConquerFear manualized intervention. Receives: Behavioral: Group-delivered ConquerFear-HK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of fear of cancer recurrence (FCR)
The primary outcome is the change in the total score of FCR assessed using the 42-item Fear of Cancer Recurrence Inventory (FCRI). The FCRI measures seven dimensions of FCR: (1) triggers, (2) severity, (3) psychological distress, (4) functional impairment, (5) reassurance, (6) insights, and (7) coping strategies. All items are rated on 5-point Likert scales ranging from 0 (not at all or never) to 4 (a great deal or all the time). Higher scores indicate higher levels of FCR.
Measured: baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).
Secondary outcomes (2)
Change of metacognitions
Metacognition assessed by the 30-item Metacognitions Questionnaire (MCQ). The MCQ assesses individual differences in metacognitive beliefs, judgements, and monitoring tendencies across five domains: (1) positive beliefs about worry, (2) negative beliefs about thoughts concerning uncontrollability and danger, (3) cognitive confidence, (4) cognitive self-consciousness, and (5) the need to control thoughts. All items are rated on a 4-point Likert scale ranging from 1 (do not agree) to 4 (agree very much). Higher scores indicate higher levels of maladaptive metacognition.
Measured: baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).
Change of cognitive attentional syndrome
CAS measured by the 16-item Cognitive Attentional Syndrome-1 (CAS-1) questionnaire.The CAS-1 assesses the frequency of engaging in rumination, threat monitoring, and coping behaviors, as well as the level of metacognitive beliefs. Each item is rated on a 9-point Likert scale ranging from 0 to 8, except for items measuring metacognitive beliefs, which are rated on a scale from 0 to 100. Higher scores indicate higher levels of CAS activation.
Measured: baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start11 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- First stage intervention: We will use a block randomization with randomly permuted block sizes of 2,4, and 6 to ensure close balance of the numbers in each arm. Participants will be randomised to the eConquerFear or eHealthMaintenance Second stage intervention for non-respondents: We will use a block randomization with randomly permuted block sizes of 2,4, and 6 to ensure close balance of the numbers in each arm. Participants will be randomised to the supervised, face-to-face ConquerFear intervention Vs group-delivered ConquerFear intervention.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy Lam, PhD, Principal investigator, School of Public Health, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181331
- Sponsor's protocol ID
- FCR-SMART
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be available from the PI upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Stepped-care Metacognition-based Intervention on Managing Fear of Cancer Recurrence: Sequential, Multiple Assignment, Randomized Controlled Trial (SMARTs)
- ClinicalTrials.gov ID
- NCT06181331
- Acronym / sponsor ID
- FCR-SMART
- Conditions
- Cancer, Fear of Cancer Recurrence
- Keywords
- Sequential multiple assessment randomized controlled trial, stepped-up care, psychooncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Dec 2023 (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.
A sequential multiple-assignment randomized controlled trial (SMART) will be used to assess the effect of an adaptive stepped-care intervention on FCR in cancer survivors with subclinical levels of fear of cancer recurrence.
Detailed description
The current SMART trial aims to address the following research questions and hypotheses:
- What is the best initial low-intensity unsupervised self-guided e-intervention for managing subclinical FCR? Hypothesis 1: It is better to begin adaptive interventions with eConquerFear than with eHealthMaintenance. This hypothesis will address the main effect of the first-stage intervention.
- What is the best treatment option for non-respondents to initial adaptive interventions? Hypothesis 2: Among initial non-respondents, it is better to switch to supervised, individual, face-to-face ConquerFear than to group-delivered ConquerFear. This hypothesis will address the main effect of the second-stage intervention.
- Which of the four embedded adaptive interventions (1. eConquerFear + group-delivered ConquerFear; 2. eConquerFear + Individual ConquerFear; 3. eHealthMaintenance + group-delivered ConqerFear; 4. eHealthMaintenance + Individual ConquerFear) leads to the greatest reduction in FCR? Hypothesis 3: eConquerFear + Individual ConquerFear will lead to the greatest reduction in FCR. This hypothesis will identify the best adaptive intervention.
- Given that the ConquerFear intervention aims to modify unhelpful metacognitive beliefs and cognitive-attentional syndrome (CAS), we will test if the effect of stepped-care ConquerFear intervention on FCR is mediated by its effect on maladaptive metacognition and CAS. We hypothesize that there would be an indirect effect of stepped-care ConquerFear intervention on FCR through its effect on maladaptive metacognition and CAS (Hypothesis 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- First stage intervention: We will use a block randomization with randomly permuted block sizes of 2,4, and 6 to ensure close balance of the numbers in each arm. Participants will be randomised to the eConquerFear or eHealthMaintenance Second stage intervention for non-respondents: We will use a block randomization with randomly permuted block sizes of 2,4, and 6 to ensure close balance of the numbers in each arm. Participants will be randomised to the supervised, face-to-face ConquerFear intervention Vs group-delivered ConquerFear intervention.
| Arm | Type | Receives |
|---|---|---|
| First stage intervention: eConquerFear | Experimental | Behavioral: eConquerFearParticipants in the eConquerFear intervention group will receive six online modules with each containing educational text, illustrative graphics, interactive exercises, and brief videos. Every module will teach a specific topic, such as self-examination and medical surveillance, values-based goal setting, attention training, detached mindfulness, worry management and treatment summary and relapse prevention. |
| First stage intervention: eHealthMaintenance | Active comparator | Behavioral: eHealthMaintenanceParticipants in the eHealthMaintenance group will receive six videos, which were designed to provide comprehensive lifestyle guidance (e.g., relaxation techniques, diet and physical activity advices) to help with survivors' maintenance of health in long-term. |
| Second stage intervention: ConquerFear-HK | Experimental | Behavioral: ConquerFearConquerFear-HK is a culturally adapted, manualized intervention consisting of 6 individual face-to-face sessions over 10 weeks. |
| Second stage intervention: Group-delivered ConquerFear-HK | Active comparator | Behavioral: Group-delivered ConquerFear-HKGroup-delivered ConquerFear-HK is a manualized six-session intervention over 10 weeks. The key goals of the intervention are identical to the individual-based ConquerFear manualized intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cantonese- or Mandarin-speaking Chinese patients diagnosed with curable breast, colorectal, or gynecological cancer, who had completed treatment (except endocrine therapy) within five years, and with a Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) score of 13 to 21 indicating subclinical FCR will be included.
Key exclusion criteria (1 listed)
- Patients with metastatic cancer, with a current diagnosis of depression or psychosis, or who are already receiving psychological treatment will be excluded.
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 |
|---|---|---|
| eConquerFearThe key goals of this e-intervention are to: (i) teach strategies for controlling worry and excessive threat monitoring; (ii) modify underlying unhelpful MCQ beliefs about worry; (iii) develop appropriate monitoring and screening behaviours, (iv) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (v) clarify values and encourage engagement in values-based goal setting. | Behavioural | First stage intervention: eConquerFear |
| eHealthMaintenanceeHealthMaintenance is not developed specifically to target fear of cancer recurrence through modifying participants' cognitive beliefs. Participants in this arm will receive 6 videos about relaxation, generic dietary and exercise knowledge. | Behavioural | First stage intervention: eHealthMaintenance |
| ConquerFearConquerFear is an intensive version of eConquerFear, which consists of 6 face-to-face therapist-led sessions. | Behavioural | Second stage intervention: ConquerFear-HK |
| Group-delivered ConquerFear-HKGroup-delivered ConquerFear-HK is a manualized six-session intervention over 10 weeks. The key goals of the intervention are identical to the individual-based ConquerFear manualized intervention. | Behavioural | Second stage intervention: Group-delivered ConquerFear-HK |
Primary outcome
Change of fear of cancer recurrence (FCR)
Time frame: baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).
The primary outcome is the change in the total score of FCR assessed using the 42-item Fear of Cancer Recurrence Inventory (FCRI). The FCRI measures seven dimensions of FCR: (1) triggers, (2) severity, (3) psychological distress, (4) functional impairment, (5) reassurance, (6) insights, and (7) coping strategies. All items are rated on 5-point Likert scales ranging from 0 (not at all or never) to 4 (a great deal or all the time). Higher scores indicate higher levels of FCR.
2 secondary outcomes
Change of metacognitions
Time frame: baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).
Change of cognitive attentional syndrome
Time frame: baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).
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 31 Aug 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be available from the PI upon reasonable request.
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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.
Wendy Lam, PhD principal investigator
School of Public Health, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eConquerFear, eHealthMaintenance and ConquerFear in people with Cancer and Fear of Cancer Recurrence, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 31 Aug 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 Hong Kong. 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 Danielle Ng, PhD (+852 39179897, dwlng@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of fear of cancer recurrence (FCR) (time frame: baseline, 1-week post e-intervention (T1), immediately post stepped care intervention (T2), and six months post stepped care intervention (T3).). 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 31 Aug 2026.