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NCT Number: NCT05949996

Evaluation of a Program for Routine Implementation of Symptom Distress Screening and Referral in Cancer Care

This study proposes to evaluate the process and outcome of an implementation program designed to implement nurse-led symptom distress screening and referral into routine cancer care clinics. Specifically, using a stepped-wedge cluster randomized controlled trial, This study aim to test if a systematic symptom distress screening program increases the proportion of eligible patients screened and referred compared to usual control. For process evaluation, this study will use qualitative methods to assess the experience and response to the implementation program.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JCICC, Hong Kong

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About this study

This study proposes to evaluate the process and outcome of an implementation program designed to implement nurse-led symptom distress screening and referral into routine cancer care clinics. Specifically, using a stepped-wedge cluster randomized controlled trial, this study aim to test if a systematic symptom distress screening program (i.e. using the five implementation strategies including training, audit, feedback, facilitation and adaptable workflow) increases the proportion of eligible patients screened and referred compared to usual control under which no implementation strategies will be used to facilitate the adoption of the systematic symptom distress screening and referral. The investigator hypothesize that (1) the intervention will increase the proportion of eligible patients screened; (2) the intervention will increase the proportion of patients with moderate to severe symptom distress referred for psychosocial support.

For process evaluation, this study will use qualitative methods to assess the experience and response to the implementation program.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All cancer patients within two years post-treatment attending the specialized outpatient clinics for surveillance will be eligible for symptom distress screening, with no exclusions by any demographic and clinical characteristics.

Exclusion criteria

  • All cancer patients beyond two years post-treatment

Treatment and study plan

A nurse-led symptom distress screening program

Other

Five implementation strategies will be conducted individually for each of the study unit at the timepoint when the study unit is being randomly allocated to the implementation condition. For each study unit, all nurses will first receive a half-day training. Each study unit under the implementation condition will receive weekly audit and feedback reports to summarize the proportion of eligible patients, proportion of eligible patients being screened, proportion of patients appropriately referred to JCICC. The senior research assistant with a nursing background will receive training and mentoring from the PI and will be the guided facilitator. The guided facilitator will conduct weekly site visits to address operational issues arise during the implementation. Lastly, while the choice of symptom assessment tool and referral criteria are standardized and cannot be modified, the routine workflow for each study unit can be adjusted according to its context and resources.

Primary outcomes

  1. Change in the number of eligible patient screened

    Time frame: Pre- and post-implementation phase, up to 24 months

    The primary outcome (the measurement of the reach) is the changes in the number of eligible patients screened. Using a standardized reporting form, each study site will be asked to submit a weekly record of a total number of eligible patients per clinic and the number of patients screened.

  2. Change in the number of eligible patient referred

    Time frame: Pre- and post-implementation phase, up to 24 months

    The primary outcome (the measurement of the reach) is the changes in the number of eligible patients referred based on the predefined scores. Using a standardized reporting form, each study site will be asked to submit a weekly record of a total number of eligible patients per clinic and the number of patients referred.

Secondary outcomes

  1. Change in referral uptake

    Time frame: Pre- and post-implementation phase, up to 24 months

    The secondary outcome is the change in uptake of the referral, i.e. the proportion of referred patients accepting services.

  2. Process evaluation in providers by conducting qualitative interviews

    Time frame: post-implementation phase, up to 24 months

    Using qualitative approach with service providers (i.e. the nurses) to identify facilitators and barriers for the implementation of the symptom distress screening program, as well as their overall experience. All nursing staff from the study units involved in the symptom distress screening will be invited to join the qualitative study at the post-implementation phase.

  3. Process evaluation in patients by conducting qualitative interviews

    Time frame: post-implementation phase, up to 24 months

    We will also conduct qualitative interviews to explore patients' experiences with symptom distress screening and referral if appropriate. Patients who are referred for support services will be approached by the research assistant who will explain the purpose of the study and nature of participation, with an emphasis on confidentiality and anonymity. If agreeing to participate, the RA will obtain a written consent and each subject will subsequently participate in in-depth interview by a trained interviewer. For patients who decline to be referred for support services, we will ask the nursing staff to invite the patients to join the qualitative study. We will recruit patients from both implementation and control conditions as it will enable us to compare patients' experienc.

  4. Number of staff receiving training

    Time frame: pre-implementation phase, up to 24 months

    All nurses will first receive a half-day training on how to administer the symptom distress screening tool, evaluate patients' reported symptom distress, refer patients to and follow-up for referred patients. We will record the number of invited staff attending the half-day training workshop.

  5. Change in staff knowledge about the implementation of the screening programme assessed using categorical Likert scales

    Time frame: pre- and post-training workshop, and post-implementation phase, up to 24 months

    We will assess the staff knowledge at pre- and post-training workshop and again at the end of the implementation study using a 6 points-categorical Likert scale (0-5) for participants' knowledge about the implementation of the screening program. Such information will be served as implementation indicators to facilitate the interpretation of the study findings.

  6. Change in staff's belief in the symptom distress screening programme assessed using categorical Likert scales

    Time frame: pre- and post-training workshop, and post-implementation phase, up to 24 months

    We will assess the staff's belief at pre- and post-training workshop and again at the end of the implementation study using a 6 points-categorical Likert scale (0-5) for participants' beliefs towards the symptom distress screening programme. Such information will be served as implementation indicators to facilitate the interpretation of the study findings.

  7. Change in staff self-efficacy in administrating the symptom distress screening programme assessed using categorical Likert scales

    Time frame: pre- and post-training workshop, and post-implementation phase, up to 24 months

    We will assess the staff's self-efficacy at pre- and post-training workshop and again at the end of the implementation study using a 6 points-categorical Likert scale (0-5). Such information will be served as implementation indicators to facilitate the interpretation of the study findings.

Study contacts

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

Wendy Wing Tak Lam, PhD

CONTACT

[email protected]

+852 39179878

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Health and Medical Research Fund

Registry information

Official study title

Evaluation of a Program for Routine Implementation of Symptom Distress Screening and Referral in Cancer Care: a Stepped Wedge Cluster Randomized Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2023
Registry last updated
Apr 3, 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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