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

Not Applicable

Recruiting

• Conditions: Fear of Cancer Recurrence; Cancer
• Interventions: Behavioral: FCR screening and referral program

• Registration Number: NCT06181344
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-26
• Study Start: 2024-07-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-12-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1980

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
implementation condition	FCR screening and referral program	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.

Primary Outcome Measures

Name	Time	Method
Change in the number of eligible patient referred	Pre- and post-implementation phase, up to 24 months	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.
Change in the number of eligible patient screened	Pre- and post-implementation phase, up to 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in referral uptake	Pre- and post-implementation phase, up to 24 months	The secondary outcome is the change in uptake of the referral, i.e. the proportion of referred patients accepting services.
Change in staff self-efficacy in administrating the symptom distress screening programme assessed using categorical Likert scales	Pre- and post-implementation phase, up to 24 months	The investigators 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.
Number of staff receiving training	Pre- and post-implementation phase, up to 24 months	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. The investigators will record the number of invited staff attending the half-day training workshop.
Process evaluation in providers by conducting qualitative interviews	Pre- and post-implementation phase, up to 24 months	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.
Process evaluation in patients by conducting qualitative interviews	Pre- and post-implementation phase, up to 24 months	The investigators 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, the investigators will ask the nursing staff to invite the patients to join the qualitative study. The investigators will recruit patients from both implementation and control conditions as it will enable us to compare patients' experience.
Change in staff's belief in the symptom distress screening programme assessed using categorical Likert scales	Pre- and post-implementation phase, up to 24 months	The investigators 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.
Change in staff knowledge about the implementation of the screening programme assessed using categorical Likert scales	Pre- and post-implementation phase, up to 24 months	The investigators 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.

Trial Locations

Locations (2)

KWH Breast clinic; 🇭🇰 Hong Kong, Hong Kong

QMH department of Surgery; 🇭🇰 Hong Kong, Hong Kong