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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949996
• Other study ID #: UW22-645
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: The University of Hong Kong
• Contact: Wendy Wing Tak Lam, PhD
• Phone: +852 39179878
• Email: wwtlam[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 2772
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Other:
• A nurse-led symptom distress screening program
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.

Locations

Country	Name	City	State
Hong Kong	JCICC	Hong Kong
Hong Kong	Kwong Wah Hospital-Breast Center	Hong Kong
Hong Kong	North District Hospital	Hong Kong
Hong Kong	Pamela Youde Nethersole Eastern Hospital-Department of oncology	Hong Kong
Hong Kong	Prince of Wales Hospital-Department of Surgery	Hong Kong
Hong Kong	Queen Mary Hospital-Department of Obstetrics & Gynaecology	Hong Kong
Hong Kong	Queen Mary Hospital-Department of Oncology	Hong Kong
Hong Kong	Queen Mary Hospital-Department of Surgery	Hong Kong
Hong Kong	The University of Hong Kong Jockey Club Institute of Cancer Care	Hong Kong
Hong Kong	Tung Wah Hospital-Department of Surgery	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Health and Medical Research Fund

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the number of eligible patient screened	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.	Pre- and post-implementation phase, up to 24 months
Primary	Change in the number of eligible patient referred	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.	Pre- and post-implementation phase, up to 24 months
Secondary	Change in referral uptake	The secondary outcome is the change in uptake of the referral, i.e. the proportion of referred patients accepting services.	Pre- and post-implementation phase, up to 24 months
Secondary	Process evaluation in providers by conducting qualitative interviews	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.	post-implementation phase, up to 24 months
Secondary	Process evaluation in patients by conducting qualitative interviews	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.	post-implementation phase, up to 24 months
Secondary	Number of staff receiving training	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.	pre-implementation phase, up to 24 months
Secondary	Change in staff knowledge about the implementation of the screening programme assessed using categorical Likert scales	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.	pre- and post-training workshop, and post-implementation phase, up to 24 months
Secondary	Change in staff's belief in the symptom distress screening programme assessed using categorical Likert scales	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.	pre- and post-training workshop, and post-implementation phase, up to 24 months
Secondary	Change in staff self-efficacy in administrating the symptom distress screening programme assessed using categorical Likert scales	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.	pre- and post-training workshop, and post-implementation phase, up to 24 months

External Links

•   HKU JCICC, a local cancer care centre