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NCT Number: NCT07273682

Nurse-led Transitional Care to Improve Symptom Management in Childhood Cancer Survivors

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.

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Key information

Conditions

Pediatric Cancer Neoplasms

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for CCSs:

  • aged between 13 and 18 years
  • diagnosed with any cancer
  • completion of active cancer treatment within a month
  • communicate in Chinese

Inclusion criteria

for parents:

  • 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

Exclusion criteria

for CCSs:

  • cognitive impairment
  • social and/or behavioural problem
  • have terminal cancer
  • participate in any similar intervention

Exclusion criteria

for parents:

  • severe emotional problems
  • participate in any similar intervention

Treatment and study plan

Counseling based on Omaha system

Other

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 Care

Other

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.

Primary outcomes

  1. Screening rate

    Time frame: Baseline

    Number of dyads screened divided by number of dyads available for screening.

  2. Eligibility rate

    Time frame: Baseline

    Number of dyads eligible divided by number of dyads screened.

  3. Recruitment rate

    Time frame: Baseline

    Number of eligible dyads agree to join divided by number of eligible dyads.

  4. Randomization rate

    Time frame: Baseline

    Number of dyads being randomized divided by number of participating dyads.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. Caregiver burden of parents

    Time frame: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion

    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.

  4. Caregiving competence of parents

    Time frame: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion

    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.

  5. 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

    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.

  6. Number of emergency department (ED) visits

    Time frame: During the study period including 12-week intervention and 6 months follow up

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ka Yan Ho

CONTACT

[email protected]

+8527666417

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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