Low Risk Differentiated Thyroid CancerNCT05510934
Shared Care Thyroid Cancer Follow-up Utilizing Thyroid Cancer Assessment Reminder System (TCARS) Study - A Pilot Study.
An observational study of Low Risk Differentiated Thyroid Cancer, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Risk Differentiated Thyroid Cancer
- What is being tested?
- Shared-care model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2022to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Control group = 30 patients, where 15 patients are from the Nova Scotia central zone, and 15 patients are from the Nova Scotia non-central zone. Shared-care group = 30 patients, where 15 patients are from the Nova Scotia central zone, and patients are from the Nova Scotia non-central zone .
Who may be able to join
- Adult (>18 years old) consenting patients being followed at the Halifax Interdisciplinary Thyroid Oncology Clinic (ITOC) meeting the following criteria:
- AJCC stage 1 DTC with no radiological or biochemical evidence of thyroid cancer with undetectable high sensitivity serum thyroglobulin (hsTG <0.06 mcg/L*);
- Anti-thyroglobulin antibody (anti-TG AB <20 IU/ml*);
- Thyroid ultrasound scan [USS] negative for regional recurrence at least 24 months after most recent treatment;
- AJCC stage 2 DTC with no radiological or biochemical evidence of cancer (undetectable hsTG and anti-TG AB and negative thyroid USS) at least 48 months after most recent treatment
- Patient is comfortable with using the mobile or Medable application and has access to internet.
Who cannot join
- Patient does not have a consented PCP.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Nova Scotia Health
Halifax, Nova Scotia, B2Y 1A7
Glenda McCarthy, (902) 473-4997, glenda.mccarthy@nshealth.ca
About this study
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.
Read the detailed description
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:
- Develop a digital health-based thyroid cancer assessment reminder system alerting patients and PCPs of patients' forthcoming appointment and guidelines.
- Establish an expedited referral pathway to tertiary care for rapid assessment of patients discharged to PCPs in case of a risk of recurrence.
- Identify the feasibility of the Shared-care model.
- Compare the completion of the clinical assessments between Shared-care and Control Groups.
- Compare patient and provider satisfaction and acceptability between Shared-care and Control Groups.
- Compare PCP confidence in dealing with DTC before and after study completion.
- Conditions
- Low Risk Differentiated Thyroid Cancer
- Being tested
- Shared-care model
- Keywords
- low risk DTC, Shared-care model, decentralized clinical trial (DCT), DTC, Thyroid Cancer, Feasibility Study
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared-care modelBehavioural
A Shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system (TCARS).
| Study group | Role | What they receive |
|---|---|---|
| Shared-care Group | The Shared-care Group will comprise of patients who are receiving long term follow-up care for their condition by their PCP. Receives: Behavioral: Shared-care model | |
| Control Group | The Control Group will be made of patients who are receiving long term follow-up care for their condition of low-risk DTC at the Halifax Interdisciplinary Thyroid Oncology Clinic (ITOC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcomes
These outcomes will assess the feasibility of the pilot study. These include:
- Number (%) of eligible patients who are approached for the study and agree to participate in either group.
- Number (%) of eligible patients who are are approached for the study but refuse to participate in either group and reason for refusal.
- Number (%) of patients who remain in the shared-care group at study end.
- Number of patients who choose to terminate the study in either group and reason for termination.
- Number of patients who lost their PCP and returned to specialist care.
Measured: after up to 24 months (after the 2nd Follow-up)
DTC shared-care outcomes
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:
- Number (%) of patients having annual TG/anti-TG AB.
- Number (%) of patients having annual neck ultrasound.
- Number (%) of patients with TSH test every 6 months.
- Number (%) of patients with TSH within target range and if outside target, whether thyroxine dose was adjusted and TSH rechecked.
- Number (%) of patients with abnormal findings on neck ultrasound or TG/anti-TG AB test.
- Number (%) of patients who were referred back to ITOC using the expedited referral sheet and reason for referral.
Measured: after up to 24 months (after the 2nd Follow-up)
Secondary outcomes (3)
Patient satisfaction outcomes
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.
Measured: after up to 5 months (after 1st follow-up) and after up to 24 months (after 2nd follow-up)
Patient and provider acceptability and experience outcomes
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).
Measured: after up to 24 months (after 2nd Follow-up)
PCP confidence in DTC management outcomes
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:
- Role of serum hsTG and anti-TG AB in long term surveillance.
- Role of neck US in long term surveillance.
- When to end long term surveillance.
- When to refer back to specialist. All responses will be on a 5-point Likert type not at all confident to very confident.
Measured: after up to 5 months (after 1st follow-up) and after up to 24 months (after 2nd follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start30 Sep 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Risk Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed A. Imran, Dr., Principal investigator, Nova Scotia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510934
- Sponsor's protocol ID
- TCARS-2022
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Care Thyroid Cancer Follow-up Utilizing Thyroid Cancer Assessment Reminder System (TCARS) Study - A Pilot Study.
- ClinicalTrials.gov ID
- NCT05510934
- Acronym / sponsor ID
- TCARS-2022
- Conditions
- Low Risk Differentiated Thyroid Cancer
- Keywords
- low risk DTC, Shared-care model, decentralized clinical trial (DCT), DTC, Thyroid Cancer, Feasibility Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Develop a digital health-based thyroid cancer assessment reminder system alerting patients and PCPs of patients' forthcoming appointment and guidelines.
- Establish an expedited referral pathway to tertiary care for rapid assessment of patients discharged to PCPs in case of a risk of recurrence.
- Identify the feasibility of the Shared-care model.
- Compare the completion of the clinical assessments between Shared-care and Control Groups.
- Compare patient and provider satisfaction and acceptability between Shared-care and Control Groups.
- Compare PCP confidence in dealing with DTC before and after study completion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared-care Group | – | Behavioral: Shared-care modelThe Shared-care Group will comprise of patients who are receiving long term follow-up care for their condition by their PCP. |
| Control Group | – | –The Control Group will be made of patients who are receiving long term follow-up care for their condition of low-risk DTC at the Halifax Interdisciplinary Thyroid Oncology Clinic (ITOC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Control group = 30 patients, where 15 patients are from the Nova Scotia central zone, and 15 patients are from the Nova Scotia non-central zone. Shared-care group = 30 patients, where 15 patients are from the Nova Scotia central zone, and patients are from the Nova Scotia non-central zone .
Key inclusion criteria (6 listed)
- Adult (>18 years old) consenting patients being followed at the Halifax Interdisciplinary Thyroid Oncology Clinic (ITOC) meeting the following criteria:
- AJCC stage 1 DTC with no radiological or biochemical evidence of thyroid cancer with undetectable high sensitivity serum thyroglobulin (hsTG <0.06 mcg/L*);
- Anti-thyroglobulin antibody (anti-TG AB <20 IU/ml*);
- Thyroid ultrasound scan [USS] negative for regional recurrence at least 24 months after most recent treatment;
- AJCC stage 2 DTC with no radiological or biochemical evidence of cancer (undetectable hsTG and anti-TG AB and negative thyroid USS) at least 48 months after most recent treatment
Key exclusion criteria (1 listed)
- Patient does not have a consented PCP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared-care modelA Shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system (TCARS). | Behavioural | Shared-care Group |
Primary outcome
Feasibility outcomes
Time frame: after up to 24 months (after the 2nd Follow-up)
These outcomes will assess the feasibility of the pilot study. These include: * Number (%) of eligible patients who are approached for the study and agree to participate in either group. * Number (%) of eligible patients who are are approached for the study but refuse to participate in either group and reason for refusal. * Number (%) of patients who remain in the shared-care group at study end. * Number of patients who choose to terminate the study in either group and reason for termination. * Number of patients who lost their PCP and returned to specialist care.
DTC shared-care outcomes
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: * Number (%) of patients having annual TG/anti-TG AB. * Number (%) of patients having annual neck ultrasound. * Number (%) of patients with TSH test every 6 months. * Number (%) of patients with TSH within target range and if outside target, whether thyroxine dose was adjusted and TSH rechecked. * Number (%) of patients with abnormal findings on neck ultrasound or TG/anti-TG AB test. * Number (%) of patients who were referred back to ITOC using the expedited referral sheet and reason for referral.
3 secondary outcomes
Patient satisfaction outcomes
Time frame: after up to 5 months (after 1st follow-up) and after up to 24 months (after 2nd follow-up)
Patient and provider acceptability and experience outcomes
Time frame: after up to 24 months (after 2nd Follow-up)
PCP confidence in DTC management outcomes
Time frame: after up to 5 months (after 1st follow-up) and after up to 24 months (after 2nd follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed A. Imran, Dr. principal investigator
Nova Scotia Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Risk Differentiated Thyroid Cancer, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Syed A. Imran, Dr. (902-473-2952, Ali.Imran@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcomes (time frame: after up to 24 months (after the 2nd Follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.