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

NCT07273682 | Not Yet Recruiting

• 1 other identifier: nurse-facilitated care
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

Omaha system; nurse-facilitated; interdisciplinary transitional care programme; Chinese childhood cancer survivors

Outcome Measures

Primary Outcomes (9)

• Screening rate

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

  Baseline

• Eligibility rate

  Number of dyads eligible divided by number of dyads screened.

  Baseline

• Recruitment rate

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

  Baseline

• Randomization rate

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

  Baseline

• Intervention attendance rate

  Number of dyads who complete the intervention divided by number of dyads in the intervention group.

  Immediately after the intervention completion

• Retention rate

  Number of dyads remaining in the study divided by number of dyads being randomized.

  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.

  Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion

• Missing data

  Percentage of missing data

  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.

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

Secondary Outcomes (6)

• Cancer-related symptoms in CCSs

  Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion

• CCSs' quality of life (QoL)

  Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion

• Caregiver burden of parents

  Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion

• Caregiving competence of parents

  Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion

• Parental quality of life (QoL)

  Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion

Study Arms (2)

Intervention group

EXPERIMENTAL

Other: Counseling based on Omaha system

Wait-list control group

OTHER

Other: Counseling based on Omaha system; Other: Usual Care

Interventions

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.

Intervention group; Wait-list control group

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.

Wait-list control group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Ka Yan Ho

CONTACT

+8527666417; kyeva.ho@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 9, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-10