Neoplasms

Gland and Hormone Related Diseases

All Conditions

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

* Administration of 1.1 GBq of I131 is given after the second intramuscular injections of rhTSH (0.9 mg). A whole body scan (WBS) is performed 2 to 5 days after the administration or I131 with determination of the neck uptake.
* Follow-up consists in:

  * 10 (+/- 2 months) after randomization: neck ultrasound + a serum Tg measurement after rhTSH stimulation
  * 2 years (+/- 2 months) after randomization: serum Tg measurement under LT4 treatment (Tg/LT4)
  * 3 years (+/- 2 months) after randomization: neck ultrasound and a serum Tg/LT4
  * 4 years (+/- 2 months) after randomization: a serum Tg/LT4
  * 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  * 8 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  * 10 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  * 12 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4

Patients randomized in the follow up group neither received 131I nor rhTSH. Patients will undergo the same followup procedures as patients randomized to the ablation group, except that at 10 months after randomization, Tg will be measured under LT4 treatment and not after rhTSH stimulation.

Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment

rhTSH stimulation

An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH.

I131

* 10 (+/- 2 months) after randomization: a neck ultrasound and a serum Tg measurement after rhTSH or LT4 stimulation
* 2 years (+/- 2 months) after randomization: a serum Tg measurement under LT4 treatment (Tg/LT4)
* 3 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
* 4 years (+/- 2 months) after randomization: a serum Tg/LT4
* 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
* 8 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
* 10 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
* 12 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4

Follow up

Open-label randomized phase III trial, using a non-inferiority comparison design. After randomization,patients will receive either post-operative radioiodine ablation with an activity of 1.1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation group) or be followed-up (without postoperative radioiodine ablation) (follow-up group).

The objective is to assess the non-inferiority of the proportion of patients without tumor-related event evaluated at three years after randomisation in the absence of radioiodine ablation (follow-up group) compared to the ablation group, in patients with low-risk differentiated thyroid cancer treated with total thyroidectomy with or without lymph node dissection (pT1am N0 or Nx, pT1b N0 or Nx)

Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?

Gustave Roussy, Cancer Campus, Grand Paris

The Shared-care Group will comprise of patients who are receiving long term follow-up care for their condition by their PCP.

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).

A Shared care follow-up strategy involving patients, PCPs and specialists that uses an automated reminder system (TCARS).

Shared-care model

Syed A. Imran, Dr.

Glenda Mccarthy

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.

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:

1. Develop a digital health-based thyroid cancer assessment reminder system alerting patients and PCPs of patients' forthcoming appointment and guidelines.
2. Establish an expedited referral pathway to tertiary care for rapid assessment of patients discharged to PCPs in case of a risk of recurrence.
3. Identify the feasibility of the Shared-care model.
4. Compare the completion of the clinical assessments between Shared-care and Control Groups.
5. Compare patient and provider satisfaction and acceptability between Shared-care and Control Groups.
6. Compare PCP confidence in dealing with DTC before and after study completion.

Shared Care Thyroid Cancer Follow-up Utilizing Thyroid Cancer Assessment Reminder System (TCARS) Study - A Pilot Study.

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.

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.

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.

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.

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).

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?	NCT01837745	Low Risk Differ...	rhTSH stimulati... I131 Follow up	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
Shared Care Thyroid Cancer Follow-up Utilizing Thyroid Cancer Assessment Reminder System (TCARS) Study - A Pilot Study.	NCT05510934	Low Risk Differ...	Shared-care mod...	18 Years -	Nova Scotia Health Authority

Spots Global Cancer Trial Database for low risk differentiated thyroid cancer