CancerNCT06207006
E-intervention on Subclinical Fear of Cancer Recurrence
A study testing eConquerFear-HK and Basic Cancer Care in people with Cancer and Psychooncology, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The present study aims to adapt a metacognition-based ConquerFear-HK to an internet-based self-management intervention, namely eConquerFear-HK and evaluate in a randomised controlled trial, its feasibility, utility, and potential effectiveness on fear of cancer recurrence reduction among local Chinese cancer survivors… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Psychooncology, Fear of Cancer Recurrence
- What is being tested?
- eConquerFear-HK and Basic Cancer Care
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 May 2024to 11 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 cancer survivors
- recently diagnosed with potentially curable (stage 0 to III) colorectal or breast cancer
- had recently completed surgery as primary treatment
- have completed hospital-based adjuvant treatments (including radiotherapy and chemotherapy) within the past six months
- scored 13 to 21 on the fear of cancer recurrence-short form will be recruited.
Who cannot join
- non-Chinese ethnicity
- metastatic cancer
- with current diagnosis of depression or psychosis or are currently receiving psychological treatments
- language or intellectual difficulties that prevent them from understanding the intervention content
- having limited or no Internet access.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conquering Fear Online: a Pilot Randomised Controlled Trial Assessing the Efficacy and Feasibility of an Internet-based Self-management Intervention on Subclinical Fear of Cancer Recurrence
The present study aims to adapt a metacognition-based ConquerFear-HK to an internet-based self-management intervention, namely eConquerFear-HK and evaluate in a randomised controlled trial, its feasibility, utility, and potential effectiveness on fear of cancer recurrence reduction among local Chinese cancer survivors with subclinical fear of cancer recurrence.
Read the detailed description
A pilot randomised controlled feasibility trial will used to test the feasibility, utility, and potential effectiveness of an internet-based self-management intervention for fear of cancer recurrence among local Chinese cancer survivors with subclinical fear of cancer recurrence.
The following hypotheses will be tested:
- There will be a greater FCR improvement in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
- There will be a greater MCQ reduction in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
- There will be greater improvements in secondary outcomes (psychological distress and quality of life) in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
- Cancer survivors receiving eConquerFear-HK intervention will perceive the intervention useful for managing their FCR and be satisfied with the intervention.
- Cancer survivors receiving eConquerFear-HK intervention will show high completion rates.
- Conditions
- Cancer, Psychooncology, Fear of Cancer Recurrence
- Being tested
- eConquerFear-HK, Basic Cancer Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eConquerFear-HKBehavioural
The key goals of the 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.
Basic Cancer CareBehavioural
Basic Cancer Care serves as an active comparator and 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.
| Study group | Role | What they receive |
|---|---|---|
| eConquerFear-HK | Experimental | Participants in the eConquerFear-HK 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-HK |
| Basic Cancer Care | Active comparator | Participants in the control 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: Basic Cancer Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of subject recruitment
number of participants consent and being randomized/number of eligible patients x 100
Measured: baseline
Rate of subject retention
number of participants who complete follow-up assessments at 3 and 6 months post-baseline/number of participants enrolled x 100
Measured: baseline,3-months post-intervention and 6-months post-intervention
Adherence rate to intervention
number of participants who complete the intervention/number of being allocated to attend the intervention x 100
Measured: the immediate post-intervention
Intervention utility
Intervention utility will be assessed using the site use metrics, including total number of log-ins
Measured: the immediate post-intervention
Acceptability of the intervention
Acceptability of the intervention will be assessed using the 22-item measure, which was adopted from the 31-item measure designed to assess the general views on the presentation and content of information in a decision aid intervention for treatment decision making. It assess the comprehensibility of the intervention content and also its utility using 4- (1 = "Poor"; 2 = "Fair"; 3 = "Good"; 4 = "Excellent") or 5-option (1 ="strongly disagree"; 5 = "strongly agree") categorical responses, respectively. Higher scores indicate better acceptability.
Measured: the immediate post-intervention
Change of fear of cancer recurrence
Fear of cancer recurrence. FCR will be assessed using the Chinese 42-item Fear of Cancer Recurrence Inventory (FCRI) at four assessment points (T0-T3).(5) FCRI comprises seven subscales: trigger, severity, psychological distress, functional impairment, reassurance, insights and coping strategies measured using 5-point Likert scales (0 = "never"; 4 = " a great deal or all the time").(5) Total scores range from 0 to 168; with higher scores indicating higher FCR.
Measured: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
Secondary outcomes (5)
Change of quality of life
Quality of life will be measured by the Chinese version of the 30-item European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), consisting of five functional subscales (physical, role, emotional, cognitive, and social functioning), three symptom subscales (pain, fatigue and nausea/vomiting), a global health subscale, five single symptom items (e.g., sleep disturbance, dyspnea, appetite loss, constipation, and diarrhea), and an single item for financial difficulty. The score range is 0-100. High scores on the functional and global health subscales indicate better functioning and QoL, respectively. High scores on the symptom subscale or item indicate more symptom(s).
Measured: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
Change of general psychological distress
e Chinese 14-item Hospital Anxiety and Depression Scale (HADS),(21) comprising two 7-item subscales that measure anxiety and depression. Each subscale total scores range from 0 to 21 with higher scores suggesting higher distress.
Measured: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
Attitude towards internet assessed using categorical Likert scales
Attitude towards internet will be assessed using a 6 points-categorical Likert scale (0-5) asking if they find internet easy to use. Higher scores indicate more positive attitude towards internet.
Measured: the immediate post-intervention
Treatment satisfaction
A 17-item treatment satisfaction questionnaire, originally designed to evaluate overall satisfaction with the intervention in our current RCT of ConquerFear-HK, will be used. The first 9 items will be assessed using a 5 points-categorical Likert scale (1-5) Higher scores indicate higher satisfaction. The remaining questions are open-questions.
Measured: the immediate post-intervention
Change of metacognition
Metacognition will be assessed at T0-T3 using the 30-item Metacognitions Questionnaire- 30 (MCQ-30), consisting of five subscales assessing Positive beliefs about worry, Negative beliefs about worry, Cognitive Self-Consciousness, Cognitive Confidence, and Need to control thoughts. A 4 points-categorical Likert scale (1-4) will be used. Higher scores indicate worse metacognition
Measured: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start2 May 2024
- Primary completion30 Jul 2025
- Study completion11 Feb 2026
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
- Parallel groups
- Model description
- A prospective, parallel RCT design will be used to assess the impact of the eConquerFear-HK intervention on FCR improvement among Chinese cancer survivors in Hong Kong. Participants will be randomly assigned to an intervention group or a control group at a 1:1 ratio, using a computer-generated block randomization sequence generated by a statistician who is blinded to the identity of participants. This allocation concealment approach minimizes risk of selection and assessment bias. The serially labelled opaque sealed envelope method will be used for randomization. Block randomization structure with randomly permuted blocks sizes of 2 and 4 will be used to ensure close balance of numbers in each arm.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Sponsor
- Investigators
- Danielle Ng, PhD, Principal investigator, School of Public Health, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207006
- Sponsor's protocol ID
- UW22-602
- 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
- Conquering Fear Online: a Pilot Randomised Controlled Trial Assessing the Efficacy and Feasibility of an Internet-based Self-management Intervention on Subclinical Fear of Cancer Recurrence
- ClinicalTrials.gov ID
- NCT06207006
- Acronym / sponsor ID
- UW22-602
- Conditions
- Cancer, Psychooncology, Fear of Cancer Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 2 May 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 16 Jan 2024 (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 present study aims to adapt a metacognition-based ConquerFear-HK to an internet-based self-management intervention, namely eConquerFear-HK and evaluate in a randomised controlled trial, its feasibility, utility, and potential effectiveness on fear of cancer recurrence reduction among local Chinese cancer survivors with subclinical fear of cancer recurrence.
Detailed description
A pilot randomised controlled feasibility trial will used to test the feasibility, utility, and potential effectiveness of an internet-based self-management intervention for fear of cancer recurrence among local Chinese cancer survivors with subclinical fear of cancer recurrence.
The following hypotheses will be tested:
- There will be a greater FCR improvement in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
- There will be a greater MCQ reduction in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
- There will be greater improvements in secondary outcomes (psychological distress and quality of life) in cancer survivors receiving eConquerFear-HK intervention vs those in the active control group.
- Cancer survivors receiving eConquerFear-HK intervention will perceive the intervention useful for managing their FCR and be satisfied with the intervention.
- Cancer survivors receiving eConquerFear-HK intervention will show high completion rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, parallel RCT design will be used to assess the impact of the eConquerFear-HK intervention on FCR improvement among Chinese cancer survivors in Hong Kong. Participants will be randomly assigned to an intervention group or a control group at a 1:1 ratio, using a computer-generated block randomization sequence generated by a statistician who is blinded to the identity of participants. This allocation concealment approach minimizes risk of selection and assessment bias. The serially labelled opaque sealed envelope method will be used for randomization. Block randomization structure with randomly permuted blocks sizes of 2 and 4 will be used to ensure close balance of numbers in each arm.
| Arm | Type | Receives |
|---|---|---|
| eConquerFear-HK | Experimental | Behavioral: eConquerFear-HKParticipants in the eConquerFear-HK 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. |
| Basic Cancer Care | Active comparator | Behavioral: Basic Cancer CareParticipants in the control 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cantonese- or Mandarin-speaking Chinese cancer survivors
- recently diagnosed with potentially curable (stage 0 to III) colorectal or breast cancer
- had recently completed surgery as primary treatment
- have completed hospital-based adjuvant treatments (including radiotherapy and chemotherapy) within the past six months
- scored 13 to 21 on the fear of cancer recurrence-short form will be recruited.
Key exclusion criteria (5 listed)
- non-Chinese ethnicity
- metastatic cancer
- with current diagnosis of depression or psychosis or are currently receiving psychological treatments
- language or intellectual difficulties that prevent them from understanding the intervention content
- having limited or no Internet access.
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 |
|---|---|---|
| eConquerFear-HKThe key goals of the 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 | eConquerFear-HK |
| Basic Cancer CareBasic Cancer Care serves as an active comparator and 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 | Basic Cancer Care |
Primary outcome
Rate of subject recruitment
Time frame: baseline
number of participants consent and being randomized/number of eligible patients x 100
Rate of subject retention
Time frame: baseline,3-months post-intervention and 6-months post-intervention
number of participants who complete follow-up assessments at 3 and 6 months post-baseline/number of participants enrolled x 100
Adherence rate to intervention
Time frame: the immediate post-intervention
number of participants who complete the intervention/number of being allocated to attend the intervention x 100
Intervention utility
Time frame: the immediate post-intervention
Intervention utility will be assessed using the site use metrics, including total number of log-ins
Acceptability of the intervention
Time frame: the immediate post-intervention
Acceptability of the intervention will be assessed using the 22-item measure, which was adopted from the 31-item measure designed to assess the general views on the presentation and content of information in a decision aid intervention for treatment decision making. It assess the comprehensibility of the intervention content and also its utility using 4- (1 = "Poor"; 2 = "Fair"; 3 = "Good"; 4 = "Excellent") or 5-option (1 ="strongly disagree"; 5 = "strongly agree") categorical responses, respectively. Higher scores indicate better acceptability.
Change of fear of cancer recurrence
Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
Fear of cancer recurrence. FCR will be assessed using the Chinese 42-item Fear of Cancer Recurrence Inventory (FCRI) at four assessment points (T0-T3).(5) FCRI comprises seven subscales: trigger, severity, psychological distress, functional impairment, reassurance, insights and coping strategies measured using 5-point Likert scales (0 = "never"; 4 = " a great deal or all the time").(5) Total scores range from 0 to 168; with higher scores indicating higher FCR.
5 secondary outcomes
Change of quality of life
Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
Change of general psychological distress
Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
Attitude towards internet assessed using categorical Likert scales
Time frame: the immediate post-intervention
Treatment satisfaction
Time frame: the immediate post-intervention
Change of metacognition
Time frame: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. This study is not recruiting at the moment.
Danielle Ng, 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-HK and Basic Cancer Care in people with Cancer and Psychooncology, 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 5 inclusion and 5 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of subject recruitment (time frame: baseline). The study lists 6 primary outcomes in all. 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.