Trial Title:
Evaluation of a Program for Routine Implementation of Symptom Distress Screening and Referral in Cancer Care
NCT ID:
NCT05949996
Condition:
Neoplasms
Conditions: Keywords:
Implementation study
Symptom distress screening
Survivorship care
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
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. 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.
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
A nurse-led symptom distress screening program
Description:
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.
Arm group label:
Implementation condition
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- All cancer patients within two years post-treatment attending the specialized
outpatient clinics for surveillance will be eligible for symptom distress screening,
with no exclusions by any demographic and clinical characteristics.
Exclusion Criteria:
- All cancer patients beyond two years post-treatment
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
JCICC
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Active, not recruiting
Facility:
Name:
Kwong Wah Hospital-Breast Center
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Vanessa Chun
Email:
cok702@ha.org.hk
Facility:
Name:
North District Hospital
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Not yet recruiting
Contact:
Last name:
Angel Chan
Email:
ccs269@ha.org.hk
Facility:
Name:
Pamela Youde Nethersole Eastern Hospital-Department of oncology
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Not yet recruiting
Contact:
Last name:
Inda Soong
Email:
soongs@ha.org.hk
Facility:
Name:
Prince of Wales Hospital-Department of Surgery
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Not yet recruiting
Contact:
Last name:
Simon Ng
Email:
simonng@surgery.cuhk.edu.hk
Facility:
Name:
Queen Mary Hospital-Department of Obstetrics & Gynaecology
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Karen Chan
Email:
kklchan@hku.hk
Facility:
Name:
Queen Mary Hospital-Department of Oncology
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Not yet recruiting
Contact:
Last name:
Wendy Chan
Email:
winglok@hku.hk
Facility:
Name:
Queen Mary Hospital-Department of Surgery
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Dominic Foo
Email:
ccfoo@hku.hk
Facility:
Name:
The University of Hong Kong Jockey Club Institute of Cancer Care
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Active, not recruiting
Facility:
Name:
Tung Wah Hospital-Department of Surgery
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Not yet recruiting
Contact:
Last name:
Ava Kwong
Email:
avakwong@hku.hk
Start date:
January 8, 2024
Completion date:
September 30, 2025
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Collaborator:
Agency:
Health and Medical Research Fund
Agency class:
Other
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05949996
https://jcicc.med.hku.hk/?lang=en
