Clinical trial NCT05949996: Evaluation of a Program for Routine Implementation of Symptom Distress Screening and Referral in Cancer Care
Official title: Evaluation of a Program for Routine Implementation of Symptom Distress Screening and Referral in Cancer Care: a Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Keywords: Implementation study
Symptom distress screening
Survivorship care
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2023-07-18
Enrollment: 2772
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will use a stepped wedge cluster randomized controlled trial design in which the intervention is introduced stepwise across study units. All study units will be asked to sign a consent form for study participation and will start with the 4-month control situation (i.e. No nurse-led symptom distress screening program at the beginning of the study). Then, the study units are randomized to one of the three roll-out schedules with a 4-month duration each. At each time point, a new group of 2 or 3 study units will cross over from the control condition to the implementation condition. For each eligible patient who is approached and being screened for symptom distress, the HA nursing staff will explain the objective of the symptom distress screening and obtain written consent for agreeing to participate in the screening program.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the number of eligible patient screened
timeFrame: Pre- and post-implementation phase, up to 24 months
measure: Change in the number of eligible patient referred
timeFrame: Pre- and post-implementation phase, up to 24 months
Secondary outcomes:
measure: Change in referral uptake
timeFrame: Pre- and post-implementation phase, up to 24 months
measure: Process evaluation in providers by conducting qualitative interviews
timeFrame: post-implementation phase, up to 24 months
measure: Process evaluation in patients by conducting qualitative interviews
timeFrame: post-implementation phase, up to 24 months
measure: Number of staff receiving training
timeFrame: pre-implementation phase, up to 24 months
measure: Change in staff knowledge about the implementation of the screening programme assessed using categorical Likert scales
timeFrame: pre- and post-training workshop, and post-implementation phase, up to 24 months
measure: Change in staff's belief in the symptom distress screening programme assessed using categorical Likert scales
timeFrame: pre- and post-training workshop, and post-implementation phase, up to 24 months
measure: Change in staff self-efficacy in administrating the symptom distress screening programme assessed using categorical Likert scales
timeFrame: pre- and post-training workshop, and post-implementation phase, up to 24 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: JCICC
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital-Breast Center
city: Hong Kong
country: Hong Kong
facility: North District Hospital
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital-Department of oncology
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital-Department of Surgery
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Obstetrics & Gynaecology
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Oncology
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Surgery
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong Jockey Club Institute of Cancer Care
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital-Department of Surgery
Study officials:
affiliation: School of Public Health, The University of Hong Kong
name: Wendy Wing Tak Lam, PhD
role: PRINCIPAL_INVESTIGATOR
References: