Pediatric CancerNCT07273682
Nurse-led Transitional Care to Improve Symptom Management in Childhood Cancer Survivors
A study testing Counseling based on Omaha system in people with Pediatric Cancer, run by The Hong Kong Polytechnic University.
Trial summary
This study aims to evaluate the feasibility and preliminary effectiveness of a nurse-facilitated interdisciplinary transitional care programme, based on the Omaha system, for Chinese childhood cancer survivors (CCSs) and their parents in Hong Kong. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Counseling based on Omaha system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Jun 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged between 13 and 18 years
- diagnosed with any cancer
- completion of active cancer treatment within a month
- communicate in Chinese
- mother or father who has a significant caregiving role in the child's life
- could participate in the intervention at the same time as their child
- communicate in Chinese
- have an electronic device to access zoom
Who cannot join
- cognitive impairment
- social and/or behavioural problem
- have terminal cancer
- participate in any similar intervention
- severe emotional problems
- participate in any similar intervention
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: A Nurse-facilitated Interdisciplinary Transitional Care Programme for Childhood Cancer Survivors and Their Parents to Improve Symptom Management: a Feasibility Randomised Waitlist-controlled Trial
This study aims to evaluate the feasibility and preliminary effectiveness of a nurse-facilitated interdisciplinary transitional care programme, based on the Omaha system, for Chinese childhood cancer survivors (CCSs) and their parents in Hong Kong. Investigators will conduct a two-arm, randomized waitlist-controlled trial at the Hong Kong Children's Hospital, the only local center for CCS follow-up. Sixty-eight dyads (CCS aged 13-18 and a parent) will be randomized to either the 12-week nurse-led intervention or usual care. The intervention includes an initial face-to-face assessment and regular follow-ups via Zoom, focusing on symptom management, health education, and self-care empowerment, with referrals to other professionals as needed. The control group receives standard discharge care and educational materials, and will be offered the intervention after data collection. Outcomes will be assessed at baseline, and 3 and 6 months post-intervention, including symptom management, quality of life, caregiver burden, self-efficacy, and emergency department visits. Feasibility will be evaluated by recruitment, retention, attendance, and data completeness rates. If effective, this programme could improve transitional care and symptom management for CCSs and their families, and inform clinical practice and policy in Hong Kong and beyond.
- Conditions
- Pediatric Cancer
- Being tested
- Counseling based on Omaha system, Usual Care
- Keywords
- Omaha system, nurse-facilitated, interdisciplinary transitional care programme, Chinese childhood cancer survivors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling based on Omaha systemOther
Investigators developed the intervention based on the Omaha system and investigators' previous studies. The intervention will last for 12 weeks. During week 1, dyads (a pairing of a child with their parent) will have a 1-hour face-to-face consultation with a RN. The RN will assess every dyad using the Omaha system to identify any problems. The Omaha system covers 42 problems grouped into 4 categories, including environmental, physiological, psychosocial and health-related behaviours. After identifying the problems, the RN will deliver corresponding interventions according to the intervention scheme in the Omaha system. Subsequent follow-up will be provided by the RN via zoom during weeks 2, 3, 4, 6, 8, 10 and 12 to evaluate their progress in terms of knowledge, behaviour and status using the rating scale in the Omaha system. The RN will assign further interventions, based on the Omaha system, to address their specific needs. Each follow-up should last around 30 minutes.
Usual CareOther
Dyads in this group will receive usual care, defined as the existing care practices provided by the hospital, which include a discharge checklist and educational materials regarding the care. After the completion of data collection for all timepoints, they will be invited to join the counselling based on Omaha system intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Counseling based on Omaha system |
| Wait-list control group | Other | Not described Receives: Other: Counseling based on Omaha system; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening rate
Number of dyads screened divided by number of dyads available for screening.
Measured: Baseline
Eligibility rate
Number of dyads eligible divided by number of dyads screened.
Measured: Baseline
Recruitment rate
Number of eligible dyads agree to join divided by number of eligible dyads.
Measured: Baseline
Randomization rate
Number of dyads being randomized divided by number of participating dyads.
Measured: Baseline
Intervention attendance rate
Number of dyads who complete the intervention divided by number of dyads in the intervention group.
Measured: Immediately after the intervention completion
Retention rate
Number of dyads remaining in the study divided by number of dyads being randomized.
Measured: Baseline, immediately after the intervention completion, 3 months after intervention completion, 6 months after intervention completion
Completion rate
Number of dyads who complete the questionnaire divided by number of questionnaires distributed.
Measured: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Missing data
Percentage of missing data
Measured: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Adverse events
Number of unfavourable events and/or worsening reported.
Measured: During the study period including 12-week intervention and 6 months follow-up
Secondary outcomes (6)
Cancer-related symptoms in CCSs
It will be used to assess the cancer-related symptoms in CCSs. It has 30 items in seven domains: nutrition-related, psychosocial/central nervous system, oropharyngeal, bone marrow toxicity/neuropathy, skin/other toxicities, neurotoxicity and respiratory/other. Each item will be evaluated on a five-point scale, from 0 to 4. The psychometric properties have been well validated in CCSs.
Measured: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
CCSs' quality of life (QoL)
Paediatric Quality of Life Questionnaire (PedsQoL) will be used to assess the CCSs' QoL. It comprises 23 items. CCSs will rate their experience during the preceding month on a five-point scale. All items will be reverse-scored and linearly transformed onto a 0-100-point scale. This scale has well-established psychometric properties in CCSs.
Measured: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Caregiver burden of parents
The caregiver burden in parents will be assessed using the Chinese version of the Caregiver burden inventory (CBI), which consists of 24 items in five dimensions: time-dependence, development, physical, social and emotional burdens. Each item will be evaluated from 0 (not at all relevant) to 4 (very relevant), with the total score between 0 and 96. The Chinese version is a valid and reliable instrument for use.
Measured: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Caregiving competence of parents
Caregiving competence scale (CCS) will be used to record the competence of parents regarding their caregiving. This scale comprises four items, each of which is evaluated on a four-point rating scale, from 1 (not at all) to 4 (very much). The psychometric properties of the Chinese version have been well established.
Measured: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Parental quality of life (QoL)
Parental QoL will be assessed using the Chinese version of the EQ-5D, with one question regarding each of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The values will be weighted to convert into a value from 1 (full health) to 0 (equivalent to being dead). The psychometric properties of the EQ-5D have been well validated in the Chinese population.
Measured: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Number of emergency department (ED) visits
It will be assessed by number of walk-in visits to the emergency department. These data will be collected in the central medical system with the assistance of PI in HKCH (Hong Kong Children's Hospital).
Measured: During the study period including 12-week intervention 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 posted9 Dec 2025
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273682
- Sponsor's protocol ID
- nurse-facilitated care
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse-facilitated Interdisciplinary Transitional Care Programme for Childhood Cancer Survivors and Their Parents to Improve Symptom Management: a Feasibility Randomised Waitlist-controlled Trial
- ClinicalTrials.gov ID
- NCT07273682
- Acronym / sponsor ID
- nurse-facilitated care
- Conditions
- Pediatric Cancer
- Keywords
- Omaha system, nurse-facilitated, interdisciplinary transitional care programme, Chinese childhood cancer survivors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Dec 2025 (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 feasibility and preliminary effectiveness of a nurse-facilitated interdisciplinary transitional care programme, based on the Omaha system, for Chinese childhood cancer survivors (CCSs) and their parents in Hong Kong. Investigators will conduct a two-arm, randomized waitlist-controlled trial at the Hong Kong Children's Hospital, the only local center for CCS follow-up. Sixty-eight dyads (CCS aged 13-18 and a parent) will be randomized to either the 12-week nurse-led intervention or usual care. The intervention includes an initial face-to-face assessment and regular follow-ups via Zoom, focusing on symptom management, health education, and self-care empowerment, with referrals to other professionals as needed. The control group receives standard discharge care and educational materials, and will be offered the intervention after data collection. Outcomes will be assessed at baseline, and 3 and 6 months post-intervention, including symptom management, quality of life, caregiver burden, self-efficacy, and emergency department visits. Feasibility will be evaluated by recruitment, retention, attendance, and data completeness rates. If effective, this programme could improve transitional care and symptom management for CCSs and their families, and inform clinical practice and policy in Hong Kong and beyond.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Counseling based on Omaha system |
| Wait-list control group | Other | Other: Counseling based on Omaha system, Other: Usual Care |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- aged between 13 and 18 years
- diagnosed with any cancer
- completion of active cancer treatment within a month
- communicate in Chinese
- mother or father who has a significant caregiving role in the child's life
Key exclusion criteria (6 listed)
- cognitive impairment
- social and/or behavioural problem
- have terminal cancer
- participate in any similar intervention
- severe emotional problems
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 |
|---|---|---|
| Counseling based on Omaha systemInvestigators developed the intervention based on the Omaha system and investigators' previous studies. The intervention will last for 12 weeks. During week 1, dyads (a pairing of a child with their parent) will have a 1-hour face-to-face consultation with a RN. The RN will assess every dyad using the Omaha system to identify any problems. The Omaha system covers 42 problems grouped into 4 categories, including environmental, physiological, psychosocial and health-related behaviours. After identifying the problems, the RN will deliver corresponding interventions according to the intervention scheme in the Omaha system. Subsequent follow-up will be provided by the RN via zoom during weeks 2, 3, 4, 6, 8, 10 and 12 to evaluate their progress in terms of knowledge, behaviour and status using the rating scale in the Omaha system. The RN will assign further interventions, based on the Omaha system, to address their specific needs. Each follow-up should last around 30 minutes. | Other | Intervention group, Wait-list control group |
| Usual CareDyads in this group will receive usual care, defined as the existing care practices provided by the hospital, which include a discharge checklist and educational materials regarding the care. After the completion of data collection for all timepoints, they will be invited to join the counselling based on Omaha system intervention. | Other | Wait-list control group |
Primary outcome
Screening rate
Time frame: Baseline
Number of dyads screened divided by number of dyads available for screening.
Eligibility rate
Time frame: Baseline
Number of dyads eligible divided by number of dyads screened.
Recruitment rate
Time frame: Baseline
Number of eligible dyads agree to join divided by number of eligible dyads.
Randomization rate
Time frame: Baseline
Number of dyads being randomized divided by number of participating dyads.
Intervention attendance rate
Time frame: Immediately after the intervention completion
Number of dyads who complete the intervention divided by number of dyads in the intervention group.
Retention rate
Time frame: Baseline, immediately after the intervention completion, 3 months after intervention completion, 6 months after intervention completion
Number of dyads remaining in the study divided by number of dyads being randomized.
Completion rate
Time frame: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Number of dyads who complete the questionnaire divided by number of questionnaires distributed.
Missing data
Time frame: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Percentage of missing data
Adverse events
Time frame: During the study period including 12-week intervention and 6 months follow-up
Number of unfavourable events and/or worsening reported.
6 secondary outcomes
Cancer-related symptoms in CCSs
Time frame: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
CCSs' quality of life (QoL)
Time frame: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Caregiver burden of parents
Time frame: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Caregiving competence of parents
Time frame: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Parental quality of life (QoL)
Time frame: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Number of emergency department (ED) visits
Time frame: During the study period including 12-week intervention and 6 months follow up
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 9 Dec 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling based on Omaha system in people with Pediatric Cancer, run by The Hong Kong Polytechnic University.
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 8 inclusion and 6 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 9 Dec 2025. 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 Ka Yan Ho (+8527666417, kyeva.ho@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening rate (time frame: Baseline). The study lists 9 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 9 Dec 2025.