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

NCT06181344 | Recruiting

• 1 other identifier: UW23-458
• Study Type: interventional
• Target: 1,980
• Locations: 1 country
• Sites: 2

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.

Conditions

Fear of Cancer Recurrence; Cancer

Keywords

implementation study; Screening and referral program

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

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

• Process evaluation in patients by conducting qualitative interviews

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

• Number of staff receiving training

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

Study Arms (2)

implementation condition

EXPERIMENTAL

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.

Behavioral: FCR screening and referral program

Control condition

NO INTERVENTION

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.

Interventions

FCR screening and referral program 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.

implementation condition

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

KWH Breast clinic

Hong Kong, Hong Kong

RECRUITING

QMH department of Surgery

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Danielle Ng, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Ng, Phd

CONTACT

+852 39179897; dwlng@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: SPONSOR

Model Details: This study will use a stepped wedge cluster randomized controlled trial design in which the intervention is introduced stepwise across study units. After obtaining the consent form from the five clinical care units, they will be randomized to one of the two roll-out schedules with a 4-month duration each. All the study units will start the trial in a control condition (i.e., no implementation strategies used), then sequentially cross over from the control condition to the intervention condition, until all sites are receiving the intervention.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 26, 2023
• Study Start: July 26, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

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 (2)