Evaluation of a Program for Routine Implementation of Symptom Distress Screening and Referral in Cancer Care
- Conditions
- Neoplasms
- Interventions
- Other: A nurse-led symptom distress screening program
- Registration Number
- NCT05949996
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2772
- 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.
- All cancer patients beyond two years post-treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Implementation condition A nurse-led symptom distress screening program Under implementation condition, a nurse-led symptom distress screening program will be implemented using 5 implementation strategies including training, audit and feedback, facilitation and adaptable workflow.
- Primary Outcome Measures
Name Time Method Change in the number of eligible patient screened 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.
Change in the number of eligible patient referred 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 Outcome Measures
Name Time Method Change in referral uptake 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.
Process evaluation in providers by conducting qualitative interviews 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.
Process evaluation in patients by conducting qualitative interviews 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.
Number of staff receiving training 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.
Change in staff knowledge about the implementation of the screening programme assessed using categorical Likert scales 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.
Change in staff's belief in the symptom distress screening programme assessed using categorical Likert scales 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.
Change in staff self-efficacy in administrating the symptom distress screening programme assessed using categorical Likert scales 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.
Trial Locations
- Locations (10)
Pamela Youde Nethersole Eastern Hospital-Department of oncology
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Prince of Wales Hospital-Department of Surgery
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Queen Mary Hospital-Department of Oncology
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
The University of Hong Kong Jockey Club Institute of Cancer Care
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Tung Wah Hospital-Department of Surgery
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
JCICC
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Kwong Wah Hospital-Breast Center
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
North District Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Queen Mary Hospital-Department of Obstetrics & Gynaecology
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Queen Mary Hospital-Department of Surgery
ðŸ‡ðŸ‡°Hong Kong, Hong Kong