Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
All cancer patients beyond two years post-treatment; and diagnosed with metastatic cancer or non-breast, non-gynecological, and non-colorectal cancer.
Trial design
Design model
Crossover
Treatments tested in this trial
FCR screening and referral program
BehavioralFive 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.
Treatment groups
1,980 Participants
are divided into 2 treatment groupsGroup A: implementation conditionExperimental treatment 1 intervention
Group B: Control conditionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre- and post-implementation phase, up to 24 months2
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.
Time frame
Pre- and post-implementation phase, up to 24 monthsSecondary outcomes
1
Change in referral uptake
The secondary outcome is the change in uptake of the referral, i.e. the proportion of referred patients accepting services.
Time frame
Pre- and post-implementation phase, up to 24 months2
Process evaluation in providers by conducting qualitative interviews
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.
Time frame
Pre- and post-implementation phase, up to 24 months3
Process evaluation in patients by conducting qualitative interviews
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.
Time frame
Pre- and post-implementation phase, up to 24 months4
Number of staff receiving training
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.
Time frame
Pre- and post-implementation phase, up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Hong Kong
Lead sponsor
Health and Medical Research Fund
Collaborator
Source ClinicalTrials.gov