Nova Scotia Health
Halifax, Nova Scotia, B2Y 1A7, Canada
Location status: Recruiting
NCT Number: NCT05510934
This study aims to assess the feasibility of a shared-care model for low-risk differentiated thyroid cancer (DTC) patients, primary care practitioners (PCPs) and the tertiary care center utilizing a digital health-based thyroid cancer assessment reminder system (TCARS) in Medable with an expedited referral to specialists for rapid assessment in case of a concern of recurrence.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Halifax, Nova Scotia, B2Y 1A7, Canada
Location status: Recruiting
Low risk differentiated thyroid cancer (DTC) is being increasingly diagnosed and although its overall survival is excellent, lifelong follow-up is needed due to the risk of ongoing health challenges and the cancer recurring. While it is not feasible to follow this growing number of patients in specialist centers due to limited resources, recent studies have suggested that simply discharging them to their PCP is not ideal because many PCPs do not feel confident in managing various aspects of DTC. More importantly, a large number of patients in Nova Scotia do not have regular access to PCPs and are thus followed by walk-in clinics or nurse practitioners.The optimal approach would therefore be, to establish a shared care follow-up model including participation from patients, primary care practitioners (PCPs) and specialists.
In this study, the feasibility of a shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system will be tested. This strategy will be compared to standard specialist only follow-up. The study population comprises 60 low risk adult DTC patients who will be randomly allocated to either Shared-care or Control group on a 1:1 basis (30 patients each).
The main objectives of this study is to:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adult (>18 years old) consenting patients being followed at the Halifax Interdisciplinary Thyroid Oncology Clinic (ITOC) meeting the following criteria:
Exclusion criteria
Patient does not have a consented PCP.
A Shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system (TCARS).
Time frame: after up to 24 months (after the 2nd Follow-up)
These outcomes will assess the feasibility of the pilot study. These include:
Time frame: after up to 24 months (after the 2nd Follow-up)
These outcomes will be measured to compare shared-care vs control DTC patients during the study duration and prospectively entered into a computerized DTC outcome registry of all study patients to follow their progress. This will be separate from TCARS, which will contain no clinical information.This information will be entered by the study coordinator. These include:
Time frame: after up to 5 months (after 1st follow-up) and after up to 24 months (after 2nd follow-up)
Patient satisfaction will be assessed in both groups using the Patient Satisfaction Questionnaire Short form (PSQ -18). The PSQ-18 is a Likert scale questionnaire, consisting of 18 items tapping each of the seven dimensions of satisfaction with medical care. These are 1) general satisfaction, 2) technical quality, 3) interpersonal manner, 4) communication, 5) financial aspects, 6) time spent with doctor, and 7) accessibility and convenience.
Time frame: after up to 24 months (after 2nd Follow-up)
Patient and provider satisfaction, acceptability and experience will be assessed through qualitative data gathered by provider (Specialist and PCP) interviews (n=8) and patient focus groups (n=12-16; 2 groups of 6-8 participants each).
Time frame: after up to 5 months (after 1st follow-up) and after up to 24 months (after 2nd follow-up)
PCP involvement and confidence in DTC management outcomes will be based on previously published surveys.
The survey is based on the National Cancer Institute Survey of Physician Attitudes Regarding the Care of Cancer Survivors which was modified for thyroid cancer. In addition to the standard survey items, PCPs will be asked to report how confident they are in discussing key aspects of follow-up care with thyroid cancer survivors including:
Time frame: after up to 5 months (after 1st follow-up) and after up to 24 months (after 2nd follow-up)
Feedback on the use of the Medable (DCT) system will be assessed using qualitative data gathered through patient and PCP surveys. Some responses will be on a 5-point Likert-type scale from strongly disagree to strongly agree or very unlikely to likely. Other questions will be in a multiple choice format. An open dialogue box will appear at the end of the survey for respondents to enter additional comments.
Contact information is provided by the study sponsor or research team.
Glenda Mccarthy
CONTACT
Syed A. Imran, Dr.
CONTACT
Nova Scotia Health Authority
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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