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NCT Number: NCT07193433

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

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.

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Key information

Conditions

Carers Needs Assessment Palliative Care Supportive Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 .

Primary outcomes

  1. Caregiver burden

    Time frame: From enrollment to the end of intervention at 4 weeks

    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.

Secondary outcomes

  1. Caregiver distress

    Time frame: From enrollment to the end of intervention at 4 weeks

    The Depression, Anxiety, and Stress Scale (DASS), 4-point Likert scale ranging from 0('did not apply to me at all") to 3('applied to me very much'). The scale has 3 subscales, and the subscale score is obtained by summing up the item scores. A possible score range of 0 to 21 is each subscale. A higher score indicates greater depression, anxiety and stress.

  2. Health-related quality of life

    Time frame: From enrollment to the end of intervention at 4 weeks

    Quality of Life in Life-Threatening Illness-Family Carer (QOLLTI-F), assesses seven dimensions, encompassing environment, patient condition, your own condition, your outlook, quality of care, relationships, and financial worries. The rating scale of each tool ranges from 0 to 10, and the total score is 160 respectively, with a higher total score indicating better QOL.

  3. Reach

    Time frame: Through study completion, an average of 6 months

    eligibility rate, consent rate, participation rate, and reasons for non-participation will be used to measure reach of the intervention. All data will be collected from the study screening log.

  4. Implementation

    Time frame: Through study completion, an average of 6 months.

    Fidelity, appropriateness and acceptability of the intervention, enablers and barriers to intervention implementation as well as the cost of the implementation. Fidelity of the intervention will be measured through the intervention delivery log. The appropriate and acceptability of the intervention, enablers and barriers to the intervention implementation will be collected using a self-designed questionnaire completed by participants. The cost of the implementation of the study will be calculated based on the time of interventionists for each intervention case multiplied by hourly salary determined by the hospital authority

  5. Enablers and barriers to access, effectiveness, implementation, adoption, and maintenance

    Time frame: Up to 6 months

    We will explore enablers and barriers to access, effectiveness, implementation, adoption, and maintenance through meetings with hospital administration staff, health-related representatives and researchers before the completion of the study

Study contacts

Contact information is provided by the study sponsor or research team.

Eileen Cheng, PhD

CONTACT

[email protected]

+85227664771

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Haven of Hope Hospital
  • United Christian Hospital

Registry information

Official study title

Refinement, Pilot Implementation, and Testing of the Carer Support Needs Assessment Tool Intervention (CSNAT-I) in Hong Kong Palliative Care Settings

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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