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

T

The Hong Kong Polytechnic University

Status

Not yet enrolling

Conditions

Supportive Care
Needs Assessment
Carers
Palliative Care

Treatments

Other: CSNAT-I

Study type

Interventional

Funder types

Other

Identifiers

NCT07193433
20211161 (Other Grant/Funding Number)
05

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

CSNAT-I
Experimental group
Treatment:
Other: CSNAT-I
Usual care
No Intervention group
Description:
involve brief advice on stress management by healthcare providers on an informal basis

Trial contacts and locations

0

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Central trial contact

Eileen Cheng, PhD

Data sourced from clinicaltrials.gov

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