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

Официальное название

A Nurse-facilitated Interdisciplinary Transitional Care Programme for Childhood Cancer Survivors and Their Parents to Improve Symptom Management: a Feasibility Randomised Waitlist-controlled Trial

Обзор

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.

Вмешательства

• Другое 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
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (6)

• Cancer-related symptoms in CCSs [Срок оценки: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion]
• CCSs' quality of life (QoL) [Срок оценки: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion]
• Caregiver burden of parents [Срок оценки: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion]
• Caregiving competence of parents [Срок оценки: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion]
• Parental quality of life (QoL) [Срок оценки: Baseline, immediately after the intervention completion, 3 months after the intervention completion, 6 months after the intervention completion]
• Number of emergency department (ED) visits [Срок оценки: During the study period including 12-week intervention and 6 months follow up]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07273682 · nurse-facilitated care

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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