A Pilot Effectiveness and Implementation Trial of CSNAT-I in Hong Kong

NCT07193433 | Not Yet Recruiting DMC

• 2 other identifiers: 0520211161
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Carers; Palliative Care; Needs Assessment; Supportive Care

Outcome Measures

Primary Outcomes (1)

• Caregiver burden

  13-item Caregiver Strain Index (CSI), each item with 1 ("yes") or 0("no") responses. The total score ranges from 0 to 13 and a higher score represents greater caregiver burden.

  From enrollment to the end of intervention at 4 weeks

Secondary Outcomes (5)

• Caregiver distress

  From enrollment to the end of intervention at 4 weeks

• Health-related quality of life

  From enrollment to the end of intervention at 4 weeks

• Reach

  Through study completion, an average of 6 months

• Implementation

  Through study completion, an average of 6 months.

• Enablers and barriers to access, effectiveness, implementation, adoption, and maintenance

  Up to 6 months

Study Arms (2)

CSNAT-I

EXPERIMENTAL

Other: CSNAT-I

Usual care

NO INTERVENTION

involve brief advice on stress management by healthcare providers on an informal basis

Interventions

CSNAT-I OTHER

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 .

CSNAT-I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• paid caregivers;
• unable to complete the questionnaire due to mental impairment determined by physicians.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• United Christian Hospital: collaborator
• Haven of Hope Hospital: collaborator

Central Study Contacts

Eileen Cheng, PhD

CONTACT

+85227664771; eileen.cheng@polyu.edu.hk

Study Design

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

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 25, 2025
• Study Start: September 20, 2025
• Primary Completion: March 20, 2026
• Study Completion (Estimated): May 20, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share