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

NCT ID: NCT05949996

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2772 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-08

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Implementation condition

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.

Group Type EXPERIMENTAL

A nurse-led symptom distress screening program

Intervention Type 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.

Control condition

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health and Medical Research Fund

OTHER_GOV

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Wendy Wing Tak Lam

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wendy Wing Tak Lam, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Public Health, The University of Hong Kong

Locations

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JCICC

Hong Kong, , Hong Kong

Site Status ACTIVE_NOT_RECRUITING

Kwong Wah Hospital-Breast Center

Hong Kong, , Hong Kong

Site Status RECRUITING

North District Hospital

Hong Kong, , Hong Kong

Site Status NOT_YET_RECRUITING

Pamela Youde Nethersole Eastern Hospital-Department of oncology

Hong Kong, , Hong Kong

Site Status NOT_YET_RECRUITING

Prince of Wales Hospital-Department of Surgery

Hong Kong, , Hong Kong

Site Status NOT_YET_RECRUITING

Queen Mary Hospital-Department of Obstetrics & Gynaecology

Hong Kong, , Hong Kong

Site Status RECRUITING

Queen Mary Hospital-Department of Oncology

Hong Kong, , Hong Kong

Site Status NOT_YET_RECRUITING

Queen Mary Hospital-Department of Surgery

Hong Kong, , Hong Kong

Site Status RECRUITING

The University of Hong Kong Jockey Club Institute of Cancer Care

Hong Kong, , Hong Kong

Site Status ACTIVE_NOT_RECRUITING

Tung Wah Hospital-Department of Surgery

Hong Kong, , Hong Kong

Site Status NOT_YET_RECRUITING

Countries

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Hong Kong

Central Contacts

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Wendy Wing Tak Lam, PhD

Role: CONTACT

+852 39179878

Facility Contacts

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Vanessa Chun

Role: primary

Angel Chan

Role: primary

Inda Soong

Role: primary

Simon Ng

Role: primary

Karen Chan

Role: primary

Wendy Chan

Role: primary

Dominic Foo

Role: primary

Ava Kwong

Role: primary

Related Links

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https://jcicc.med.hku.hk/?lang=en

HKU JCICC, a local cancer care centre

Other Identifiers

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UW22-645

Identifier Type: -

Identifier Source: org_study_id

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