Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FCR screening and referral program.
- Who it may be relevant to
- Registry conditions: Fear of Cancer Recurrence, Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Behavioral 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
Primary outcome measures
- Change in the number of eligible patient screened [Time frame: Pre- and post-implementation phase, up to 24 months]
- Change in the number of eligible patient referred [Time frame: Pre- and post-implementation phase, up to 24 months]
Secondary outcome measures (7)
- Change in referral uptake [Time frame: Pre- and post-implementation phase, up to 24 months]
- Process evaluation in providers by conducting qualitative interviews [Time frame: Pre- and post-implementation phase, up to 24 months]
- Process evaluation in patients by conducting qualitative interviews [Time frame: Pre- and post-implementation phase, up to 24 months]
- Number of staff receiving training [Time frame: 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 [Time frame: Pre- and post-implementation phase, up to 24 months]
- Change in staff's belief in the symptom distress screening programme assessed using categorical Likert scales [Time frame: Pre- and post-implementation phase, up to 24 months]
- Change in staff self-efficacy in administrating the symptom distress screening programme assessed using categorical Likert scales [Time frame: Pre- and post-implementation phase, up to 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Hong Kong · 2 centers
- KWH Breast clinic — Hong Kong
- QMH department of Surgery — Hong Kong
Identifiers
NCT: NCT06181344 · UW23-458