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

NCT05949996 | Recruiting

• 1 other identifier: UW22-645
• Study Type: interventional
• Target: 2,772
• Locations: 1 country
• Sites: 10

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.

Conditions

Neoplasms

Keywords

Implementation study; Symptom distress screening; Survivorship care

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Change in referral uptake

  Pre- and post-implementation phase, up to 24 months

• Process evaluation in providers by conducting qualitative interviews

  post-implementation phase, up to 24 months

• Process evaluation in patients by conducting qualitative interviews

  post-implementation phase, up to 24 months

• Number of staff receiving training

  pre-implementation phase, up to 24 months

• 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

Study Arms (2)

Implementation condition

EXPERIMENTAL

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.

Other: A nurse-led symptom distress screening program

Control condition

NO INTERVENTION

The control condition is the usual clinical outpatient operation without the specific implementation program (i.e. applying the five implementation strategies including training, audit and feedback, facilitation and adaptable workflow) for standardized routine symptom distress screening. Prior to the start of the first 4-month control condition, we will meet each study unit and brief the staff about the purpose of this implementation study, as well as the introduction of the symptom distress screening tool. The symptom distress screening tool and referral forms will be given to the study sites. The staff are encouraged to screened and referred all eligible patients to JCICC, a local cancer care centre. In contrast to the intervention condition, there will be no half-day skill training workshop and no weekly audit and feedback report delivered and discussed with the site facilitator. We will keep the recording of the briefing session for fidelity assessment.

Interventions

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.

Implementation condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• All cancer patients beyond two years post-treatment

Sponsors & Collaborators

• The University of Hong Kong: lead
• Health and Medical Research Fund: collaborator

Study Sites (10)

JCICC

Hong Kong, Hong Kong

ACTIVE NOT RECRUITING

Kwong Wah Hospital-Breast Center

Hong Kong, Hong Kong

RECRUITING

North District Hospital

Hong Kong, Hong Kong

NOT YET RECRUITING

Pamela Youde Nethersole Eastern Hospital-Department of oncology

Hong Kong, Hong Kong

NOT YET RECRUITING

Prince of Wales Hospital-Department of Surgery

Hong Kong, Hong Kong

NOT YET RECRUITING

Queen Mary Hospital-Department of Obstetrics & Gynaecology

Hong Kong, Hong Kong

RECRUITING

Queen Mary Hospital-Department of Oncology

Hong Kong, Hong Kong

NOT YET RECRUITING

Queen Mary Hospital-Department of Surgery

Hong Kong, Hong Kong

RECRUITING

The University of Hong Kong Jockey Club Institute of Cancer Care

Hong Kong, Hong Kong

ACTIVE NOT RECRUITING

Tung Wah Hospital-Department of Surgery

Hong Kong, Hong Kong

NOT YET RECRUITING

Related Links

• HKU JCICC, a local cancer care centre

MeSH Terms

Conditions

Neoplasms

Study Officials

• Wendy Wing Tak Lam, PhD

  School of Public Health, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Wing Tak Lam, PhD

CONTACT

+852 39179878; wwtlam@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: July 18, 2023
• Study Start: January 8, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication
• Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.

Locations

HK (10)