An interventional study of Counseling based on Omaha system and Usual Care in Pediatric Cancer, sponsored by The Hong Kong Polytechnic University. Not yet recruiting. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Supportive care
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 68 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.
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Inclusion Criteria for CCSs:
Inclusion Criteria for parents:
Exclusion Criteria for CCSs:
Exclusion Criteria for parents:
Other: Counseling based on Omaha system
Other: Counseling based on Omaha system · Other: Usual Care
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.
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.
Screening rate
Number of dyads screened divided by number of dyads available for screening.
Time frame: Baseline
Eligibility rate
Number of dyads eligible divided by number of dyads screened.
Time frame: Baseline
Recruitment rate
Number of eligible dyads agree to join divided by number of eligible dyads.
Time frame: Baseline
Randomization rate
Number of dyads being randomized divided by number of participating dyads.
Time frame: Baseline
Intervention attendance rate
Number of dyads who complete the intervention divided by number of dyads in the intervention group.
Time frame: Immediately after the intervention completion
Retention rate
Number of dyads remaining in the study divided by number of dyads being randomized.
Time frame: 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.
Time frame: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion
Missing data
Percentage of missing data
Time frame: 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.
Time frame: During the study period including 12-week intervention and 6 months follow-up
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.
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)
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.
Time frame: 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.
Time frame: 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.
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)
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.
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
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).
Time frame: During the study period including 12-week intervention and 6 months follow up
No study locations are listed for this record.
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The Hong Kong Polytechnic University