Clinical trial NCT06181344: Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program
Official title: Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program for Chinese Cancer Survivors: a Stepped Wedge and Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fear of Cancer Recurrence
Cancer
Keywords: implementation study
Screening and referral program
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2023-12-26
Enrollment: 1980
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change in the number of eligible patient screened
timeFrame: Pre- and post-implementation phase, up to 24 months
measure: Change in the number of eligible patient referred
timeFrame: Pre- and post-implementation phase, up to 24 months
Secondary outcomes:
measure: Change in referral uptake
timeFrame: Pre- and post-implementation phase, up to 24 months
measure: Process evaluation in providers by conducting qualitative interviews
timeFrame: Pre- and post-implementation phase, up to 24 months
measure: Process evaluation in patients by conducting qualitative interviews
timeFrame: Pre- and post-implementation phase, up to 24 months
measure: Number of staff receiving training
timeFrame: Pre- and post-implementation phase, up to 24 months
measure: Change in staff knowledge about the implementation of the screening programme assessed using categorical Likert scales
timeFrame: Pre- and post-implementation phase, up to 24 months
measure: Change in staff's belief in the symptom distress screening programme assessed using categorical Likert scales
timeFrame: Pre- and post-implementation phase, up to 24 months
measure: Change in staff self-efficacy in administrating the symptom distress screening programme assessed using categorical Likert scales
timeFrame: Pre- and post-implementation phase, up to 24 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: KWH Breast clinic
city: Hong Kong
country: Hong Kong
facility: QMH department of Surgery
Study officials:
affiliation: The University of Hong Kong
name: Danielle Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References: