Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program

NCT ID: NCT06181344

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1980 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-26
• Study Completion Date: 2026-08-31

Brief Summary

The purpose of this study is to evaluate the process and outcomes of an implementation program designed to implement fear of cancer screening, referral and management into routine cancer care clinics, using a stepped-wedge cluster randomized controlled trial.

Detailed Description

This study aims to test if a systematic fear of cancer screening program that employs implementation strategies including training, reflecting, evaluating, facilitating and adapting, increases the proportion of eligible patients screened and referred compared to usual control with no implantation strategies used. This study hypothesize that the implementation program will increase (i) the proportion of eligible patients screened and (ii) the proportion of patients with high fear of cancer referred for psychosocial support. For process evaluation, this study aims to use qualitative methods to assess the patients' and service providers' experience of the implementation program, and identify contextual factors (e.g., potential barriers and facilitators) likely to influence its adoption, implementation, and sustainability.

Conditions

Cancer; Fear of Cancer Recurrence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

implementation condition

Under implementation condition, a fear of cancer recurrence screening program will be implemented in routine oncological clinics using 5 implementation strategies including training, audit and feedback, facilitation and adaptable workflow.

Group Type: EXPERIMENTAL

FCR screening and referral program

Intervention Type: BEHAVIORAL

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

In the control condition, the clinical outpatient operation is performed as usual. The FCR screening tool and referral forms will be provided to the study sites and nursing staff are encouraged to adopt fear of cancer recurrence screening. Patients referred to JCICC will be managed following the predefined clinical pathway triage system. A briefing session about the purpose of the implementation program and the introduction of the FCR screening tool will be given to the staff at each study unit before the start of the first 4-months control condition. The briefing session will be recorded for the purpose of fidelity assessment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FCR screening and referral 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: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All patients diagnosed with non-metastatic breast, gynecological, or colorectal cancer, and who have completed primary and adjuvant treatment within the past two years will be eligible for the proposed screening program.

Exclusion Criteria

• All cancer patients beyond two years post-treatment; and diagnosed with metastatic cancer or non-breast, non-gynecological, and non-colorectal cancer.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health and Medical Research Fund

OTHER_GOV

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Ng, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

KWH Breast clinic

Hong Kong, , Hong Kong

Site Status: RECRUITING

QMH department of Surgery

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Danielle Ng, Phd

Role: CONTACT

dwlng@hku.hk

+852 39179897

Facility Contacts

Vanessa Chun

Role: primary

cok702@ha.org.hk

85246585123

CC Foo

Role: primary

ccfoo@hku.hk

85222554389

Other Identifiers

UW23-458

Identifier Type: -

Identifier Source: org_study_id