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

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

Overview

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.

Interventions

• Other Counseling based on Omaha system
  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 ident
• Other Usual Care
  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 outcome measures

• Screening rate [Time frame: Baseline]
• Eligibility rate [Time frame: Baseline]
• Recruitment rate [Time frame: Baseline]
• Randomization rate [Time frame: Baseline]
• Intervention attendance rate [Time frame: Immediately after the intervention completion]
• Retention rate [Time frame: Baseline, immediately after the intervention completion, 3 months after intervention completion, 6 months after intervention completion]
• Completion rate [Time frame: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion]
• Missing data [Time frame: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion]
• Adverse events [Time frame: During the study period including 12-week intervention and 6 months follow-up]

Secondary outcome measures (6)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07273682 · nurse-facilitated care

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗