Fear of Cancer RecurrenceNCT06181344
Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program
A study testing FCR screening and referral program in people with Fear of Cancer Recurrence and Cancer, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
The purpose of this study is to evaluate the process and outcomes of an implementation program designed to implement fear of cancer screening, referral and management into routine cancer care clinics, using a stepped-wedge cluster randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fear of Cancer Recurrence, Cancer
- What is being tested?
- FCR screening and referral program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,980 participants
- Where
- 2 sitesHong Kong
- Study dates
- 26 Jul 2024to 31 Aug 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
- All patients diagnosed with non-metastatic breast, gynecological, or colorectal cancer, and who have completed primary and adjuvant treatment within the past two years will be eligible for the proposed screening program.
Who cannot join
- All cancer patients beyond two years post-treatment; and diagnosed with metastatic cancer or non-breast, non-gynecological, and non-colorectal cancer.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Recruiting
KWH Breast clinic
Hong Kong
Vanessa Chun, 85246585123, cok702@ha.org.hk
- Recruiting
QMH department of Surgery
Hong Kong
CC Foo, 85222554389, ccfoo@hku.hk
About this study
Official title: Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program for Chinese Cancer Survivors: a Stepped Wedge and Cluster Randomized Trial
The purpose of this study is to evaluate the process and outcomes of an implementation program designed to implement fear of cancer screening, referral and management into routine cancer care clinics, using a stepped-wedge cluster randomized controlled trial.
Read the detailed description
This study aims to test if a systematic fear of cancer screening program that employs implementation strategies including training, reflecting, evaluating, facilitating and adapting, increases the proportion of eligible patients screened and referred compared to usual control with no implantation strategies used. This study hypothesize that the implementation program will increase (i) the proportion of eligible patients screened and (ii) the proportion of patients with high fear of cancer referred for psychosocial support. For process evaluation, this study aims to use qualitative methods to assess the patients' and service providers' experience of the implementation program, and identify contextual factors (e.g., potential barriers and facilitators) likely to influence its adoption, implementation, and sustainability.
- Conditions
- Fear of Cancer Recurrence, Cancer
- Being tested
- FCR screening and referral program
- Keywords
- implementation study, Screening and referral program
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCR screening and referral programBehavioural
Five implementation strategies will be conducted individually for each of the study unit at the timepoint when the study unit is being randomly allocated to the implementation condition. For each study unit, all nurses will first receive a half-day training. Each study unit under the implementation condition will receive weekly audit and feedback reports to summarize the proportion of eligible patients, proportion of eligible patients being screened, proportion of patients appropriately referred to JCICC. The senior research assistant with a nursing background will receive training and mentoring from the PI and will be the guided facilitator. The guided facilitator will conduct weekly site visits to address operational issues arise during the implementation. Lastly, while the choice of symptom assessment tool and referral criteria are standardized and cannot be modified, the routine workflow for each study unit can be adjusted according to its context and resources.
| Study group | Role | What they receive |
|---|---|---|
| implementation condition | Experimental | Under implementation condition, a fear of cancer recurrence screening program will be implemented in routine oncological clinics using 5 implementation strategies including training, audit and feedback, facilitation and adaptable workflow. Receives: Behavioral: FCR screening and referral program |
| Control condition | No intervention | In the control condition, the clinical outpatient operation is performed as usual. The FCR screening tool and referral forms will be provided to the study sites and nursing staff are encouraged to adopt fear of cancer recurrence screening. Patients referred to JCICC will be managed following the predefined clinical pathway triage system. A briefing session about the purpose of the implementation program and the introduction of the FCR screening tool will be given to the staff at each study unit before the start of the first 4-months control condition. The briefing session will be recorded for the purpose of fidelity assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of eligible patient screened
The primary outcome (the measurement of the reach) is the changes in the number of eligible patients screened. Using a standardized reporting form, each study site will be asked to submit a weekly record of a total number of eligible patients per clinic and the number of patients screened.
Measured: Pre- and post-implementation phase, up to 24 months
Change in the number of eligible patient referred
The primary outcome (the measurement of the reach) is the changes in the number of eligible patients referred based on the predefined scores. Using a standardized reporting form, each study site will be asked to submit a weekly record of a total number of eligible patients per clinic and the number of patients referred.
Measured: Pre- and post-implementation phase, up to 24 months
Secondary outcomes (7)
Change in referral uptake
The secondary outcome is the change in uptake of the referral, i.e. the proportion of referred patients accepting services.
Measured: Pre- and post-implementation phase, up to 24 months
Process evaluation in providers by conducting qualitative interviews
Using qualitative approach with service providers (i.e. the nurses) to identify facilitators and barriers for the implementation of the symptom distress screening program, as well as their overall experience. All nursing staff from the study units involved in the symptom distress screening will be invited to join the qualitative study at the post-implementation phase.
Measured: Pre- and post-implementation phase, up to 24 months
Process evaluation in patients by conducting qualitative interviews
The investigators will also conduct qualitative interviews to explore patients' experiences with symptom distress screening and referral if appropriate. Patients who are referred for support services will be approached by the research assistant who will explain the purpose of the study and nature of participation, with an emphasis on confidentiality and anonymity. If agreeing to participate, the RA will obtain a written consent and each subject will subsequently participate in in-depth interview by a trained interviewer. For patients who decline to be referred for support services, the investigators will ask the nursing staff to invite the patients to join the qualitative study. The investigators will recruit patients from both implementation and control conditions as it will enable us to compare patients' experience.
Measured: Pre- and post-implementation phase, up to 24 months
Number of staff receiving training
All nurses will first receive a half-day training on how to administer the symptom distress screening tool, evaluate patients' reported symptom distress, refer patients to and follow-up for referred patients. The investigators will record the number of invited staff attending the half-day training workshop.
Measured: Pre- and post-implementation phase, up to 24 months
Change in staff knowledge about the implementation of the screening programme assessed using categorical Likert scales
The investigators will assess the staff knowledge at pre- and post-training workshop and again at the end of the implementation study using a 6 points-categorical Likert scale (0-5) for participants' knowledge about the implementation of the screening program. Such information will be served as implementation indicators to facilitate the interpretation of the study findings.
Measured: Pre- and post-implementation phase, up to 24 months
Change in staff's belief in the symptom distress screening programme assessed using categorical Likert scales
The investigators will assess the staff's belief at pre- and post-training workshop and again at the end of the implementation study using a 6 points-categorical Likert scale (0-5) for participants' beliefs towards the symptom distress screening programme. Such information will be served as implementation indicators to facilitate the interpretation of the study findings.
Measured: Pre- and post-implementation phase, up to 24 months
Change in staff self-efficacy in administrating the symptom distress screening programme assessed using categorical Likert scales
The investigators will assess the staff's self-efficacy at pre- and post-training workshop and again at the end of the implementation study using a 6 points-categorical Likert scale (0-5). Such information will be served as implementation indicators to facilitate the interpretation of the study findings.
Measured: Pre- and post-implementation phase, up to 24 months
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 start26 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will use a stepped wedge cluster randomized controlled trial design in which the intervention is introduced stepwise across study units. After obtaining the consent form from the five clinical care units, they will be randomized to one of the two roll-out schedules with a 4-month duration each. All the study units will start the trial in a control condition (i.e., no implementation strategies used), then sequentially cross over from the control condition to the intervention condition, until all sites are receiving the intervention.
- Masking
- None (open label)
- Enrolment
- 1,980 participants (estimated)
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, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181344
- Sponsor's protocol ID
- UW23-458
- 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 reques
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
- Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program for Chinese Cancer Survivors: a Stepped Wedge and Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06181344
- Acronym / sponsor ID
- UW23-458
- Conditions
- Fear of Cancer Recurrence, Cancer
- Keywords
- implementation study, Screening and referral program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,980 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 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.
The purpose of this study is to evaluate the process and outcomes of an implementation program designed to implement fear of cancer screening, referral and management into routine cancer care clinics, using a stepped-wedge cluster randomized controlled trial.
Detailed description
This study aims to test if a systematic fear of cancer screening program that employs implementation strategies including training, reflecting, evaluating, facilitating and adapting, increases the proportion of eligible patients screened and referred compared to usual control with no implantation strategies used. This study hypothesize that the implementation program will increase (i) the proportion of eligible patients screened and (ii) the proportion of patients with high fear of cancer referred for psychosocial support. For process evaluation, this study aims to use qualitative methods to assess the patients' and service providers' experience of the implementation program, and identify contextual factors (e.g., potential barriers and facilitators) likely to influence its adoption, implementation, and sustainability.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will use a stepped wedge cluster randomized controlled trial design in which the intervention is introduced stepwise across study units. After obtaining the consent form from the five clinical care units, they will be randomized to one of the two roll-out schedules with a 4-month duration each. All the study units will start the trial in a control condition (i.e., no implementation strategies used), then sequentially cross over from the control condition to the intervention condition, until all sites are receiving the intervention.
| Arm | Type | Receives |
|---|---|---|
| implementation condition | Experimental | Behavioral: FCR screening and referral programUnder implementation condition, a fear of cancer recurrence screening program will be implemented in routine oncological clinics using 5 implementation strategies including training, audit and feedback, facilitation and adaptable workflow. |
| Control condition | No intervention | –In the control condition, the clinical outpatient operation is performed as usual. The FCR screening tool and referral forms will be provided to the study sites and nursing staff are encouraged to adopt fear of cancer recurrence screening. Patients referred to JCICC will be managed following the predefined clinical pathway triage system. A briefing session about the purpose of the implementation program and the introduction of the FCR screening tool will be given to the staff at each study unit before the start of the first 4-months control condition. The briefing session will be recorded for the purpose of fidelity assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients diagnosed with non-metastatic breast, gynecological, or colorectal cancer, and who have completed primary and adjuvant treatment within the past two years will be eligible for the proposed screening program.
Key exclusion criteria (1 listed)
- All cancer patients beyond two years post-treatment; and diagnosed with metastatic cancer or non-breast, non-gynecological, and non-colorectal cancer.
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 |
|---|---|---|
| FCR screening and referral programFive implementation strategies will be conducted individually for each of the study unit at the timepoint when the study unit is being randomly allocated to the implementation condition. For each study unit, all nurses will first receive a half-day training. Each study unit under the implementation condition will receive weekly audit and feedback reports to summarize the proportion of eligible patients, proportion of eligible patients being screened, proportion of patients appropriately referred to JCICC. The senior research assistant with a nursing background will receive training and mentoring from the PI and will be the guided facilitator. The guided facilitator will conduct weekly site visits to address operational issues arise during the implementation. Lastly, while the choice of symptom assessment tool and referral criteria are standardized and cannot be modified, the routine workflow for each study unit can be adjusted according to its context and resources. | Behavioural | implementation condition |
Primary outcome
Change in the number of eligible patient screened
Time frame: Pre- and post-implementation phase, up to 24 months
The primary outcome (the measurement of the reach) is the changes in the number of eligible patients screened. Using a standardized reporting form, each study site will be asked to submit a weekly record of a total number of eligible patients per clinic and the number of patients screened.
Change in the number of eligible patient referred
Time frame: Pre- and post-implementation phase, up to 24 months
The primary outcome (the measurement of the reach) is the changes in the number of eligible patients referred based on the predefined scores. Using a standardized reporting form, each study site will be asked to submit a weekly record of a total number of eligible patients per clinic and the number of patients referred.
7 secondary outcomes
Change in referral uptake
Time frame: Pre- and post-implementation phase, up to 24 months
Process evaluation in providers by conducting qualitative interviews
Time frame: Pre- and post-implementation phase, up to 24 months
Process evaluation in patients by conducting qualitative interviews
Time frame: Pre- and post-implementation phase, up to 24 months
Number of staff receiving training
Time frame: Pre- and post-implementation phase, up to 24 months
Change in staff knowledge about the implementation of the screening programme assessed using categorical Likert scales
Time frame: Pre- and post-implementation phase, up to 24 months
Change in staff's belief in the symptom distress screening programme assessed using categorical Likert scales
Time frame: Pre- and post-implementation phase, up to 24 months
Change in staff self-efficacy in administrating the symptom distress screening programme assessed using categorical Likert scales
Time frame: Pre- and post-implementation phase, up to 24 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 31 Aug 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be available from the PI upon reasonable reques
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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.
Danielle Ng, PhD principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FCR screening and referral program in people with Fear of Cancer Recurrence and Cancer, run by The University of Hong Kong at 2 sites 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 2 sites 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 in the number of eligible patient screened (time frame: Pre- and post-implementation phase, up to 24 months). The study lists 2 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.