Symptoms and General Pathology

All Conditions

Recurrence

Disease Attributes

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.

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.

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.

FCR screening and referral program

Danielle Ng, Phd

Danielle Ng, PhD

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.

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.

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.

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

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

All IPD that underlie results in a publication will be available from the PI upon reasonable reques

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.

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.

The secondary outcome is the change in uptake of the referral, i.e. the proportion of referred patients accepting services.

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.

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.

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.

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.

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.

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.

Health and Medical Research Fund

The University of Hong Kong

Under implementation condition, a nurse-led symptom distress screening program will be implemented using 5 implementation strategies including training, audit and feedback, facilitation and adaptable workflow.

The control condition is the usual clinical outpatient operation without the specific implementation program (i.e. applying the five implementation strategies including training, audit and feedback, facilitation and adaptable workflow) for standardized routine symptom distress screening. Prior to the start of the first 4-month control condition, we will meet each study unit and brief the staff about the purpose of this implementation study, as well as the introduction of the symptom distress screening tool. The symptom distress screening tool and referral forms will be given to the study sites. The staff are encouraged to screened and referred all eligible patients to JCICC, a local cancer care centre. In contrast to the intervention condition, there will be no half-day skill training workshop and no weekly audit and feedback report delivered and discussed with the site facilitator. We will keep the recording of the briefing session for fidelity assessment.

A nurse-led symptom distress screening program

Wendy Wing Tak Lam, PhD

Vanessa Chun

Angel Chan

Inda Soong

Simon Ng

Karen Chan

Wendy Chan

Dominic Foo

Ava Kwong

This study proposes to evaluate the process and outcome of an implementation program designed to implement nurse-led symptom distress screening and referral into routine cancer care clinics. Specifically, using a stepped-wedge cluster randomized controlled trial, This study aim to test if a systematic symptom distress screening program increases the proportion of eligible patients screened and referred compared to usual control. For process evaluation, this study will use qualitative methods to assess the experience and response to the implementation program.

This study proposes to evaluate the process and outcome of an implementation program designed to implement nurse-led symptom distress screening and referral into routine cancer care clinics. Specifically, using a stepped-wedge cluster randomized controlled trial, this study aim to test if a systematic symptom distress screening program (i.e. using the five implementation strategies including training, audit, feedback, facilitation and adaptable workflow) increases the proportion of eligible patients screened and referred compared to usual control under which no implementation strategies will be used to facilitate the adoption of the systematic symptom distress screening and referral. The investigator hypothesize that (1) the intervention will increase the proportion of eligible patients screened; (2) the intervention will increase the proportion of patients with moderate to severe symptom distress referred for psychosocial support.

For process evaluation, this study will use qualitative methods to assess the experience and response to the implementation program.

This study will use a stepped wedge cluster randomized controlled trial design in which the intervention is introduced stepwise across study units. All study units will be asked to sign a consent form for study participation and will start with the 4-month control situation (i.e. No nurse-led symptom distress screening program at the beginning of the study). Then, the study units are randomized to one of the three roll-out schedules with a 4-month duration each. At each time point, a new group of 2 or 3 study units will cross over from the control condition to the implementation condition. For each eligible patient who is approached and being screened for symptom distress, the HA nursing staff will explain the objective of the symptom distress screening and obtain written consent for agreeing to participate in the screening program.

Evaluation of a Program for Routine Implementation of Symptom Distress Screening and Referral in Cancer Care

Evaluation of a Program for Routine Implementation of Symptom Distress Screening and Referral in Cancer Care: a Stepped Wedge Cluster Randomized Trial

All IPD that underlie results in a publication will be available from the PI upon reasonable request.

We 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, we will ask the nursing staff to invite the patients to join the qualitative study. We will recruit patients from both implementation and control conditions as it will enable us to compare patients' experienc.

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. We will record the number of invited staff attending the half-day training workshop.

We 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.

We 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.

We 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program	NCT06181344	Fear of Cancer ... Cancer	FCR screening a...	18 Years -	The University of Hong Kong
Evaluation of a Program for Routine Implementation of Symptom Distress Screening and Referral in Cancer Care	NCT05949996	Neoplasms	A nurse-led sym...	18 Years -	The University of Hong Kong
Evaluation of a Program for Routine Implementation of Symptom Distress Screening and Referral in Cancer Care	NCT05949996	Neoplasms	A nurse-led sym...	18 Years -	The University of Hong Kong
Implementation and Evaluation of a Fear of Cancer Recurrence Screening, Referral and Management Program	NCT06181344	Fear of Cancer ... Cancer	FCR screening a...	18 Years -	The University of Hong Kong

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