A Pilot Effectiveness and Implementation Trial of CSNAT-I in Hong Kong
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CSNAT-I.
- Who it may be relevant to
- Registry conditions: Carers, Palliative Care, Needs Assessment, Supportive Care. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Refinement, Pilot Implementation, and Testing of the Carer Support Needs Assessment Tool Intervention (CSNAT-I) in Hong Kong Palliative Care Settings
Overview
In this hybrid Type 1 effectiveness-implementation pilot randomized controlled trial, 60 caregivers will be randomized into either the CSNAT-I group or usual care. Preliminary effectiveness outcomes include caregiver burden, distress, and health-related quality of life. Preliminary implementation outcomes include feasibility, fidelity, appropriateness, acceptability, cost of the intervention, as well as barriers and facilitators to intervention implementation. Quantitative data will be analyzed using descriptive analysis and linear mixed effects model, while qualitative data using thematic analysis. The CSNAT-I is expected to be preliminarily effective in improving caregiver outcomes and implementable in Hong Kong palliative care context, which will serve as the foundation for a large trial before integration into daily practice.
Interventions
- Other CSNAT-I
CSNAT-I will be conducted in five stages, including an introduction of the CSNAT, family caregivers' consideration of needs, prioritize needs, a shared care plan, and a shared review for effectiveness and subsequent actions .
Primary outcome measures
- Caregiver burden [Time frame: From enrollment to the end of intervention at 4 weeks]
Secondary outcome measures (5)
- Caregiver distress [Time frame: From enrollment to the end of intervention at 4 weeks]
- Health-related quality of life [Time frame: From enrollment to the end of intervention at 4 weeks]
- Reach [Time frame: Through study completion, an average of 6 months]
- Implementation [Time frame: Through study completion, an average of 6 months.]
- Enablers and barriers to access, effectiveness, implementation, adoption, and maintenance [Time frame: Up to 6 months]
Eligibility criteria
Inclusion criteria
- adults ≥18 years old;
- family members taking a primary role in patient care at home as nominated by the palliative cancer patient;
- ability to communicate in Chinese.
Exclusion criteria
- paid caregivers;
- unable to complete the questionnaire due to mental impairment determined by physicians.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07193433 · 05 · 20211161