Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
University Health Network, Toronto
Collaborators:
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01083550
First received: February 24, 2010
Last updated: September 23, 2015
Last verified: September 2015
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Purpose
In this study, we will test, using a randomized controlled trial design, whether the use of a computer-based decision aid (DA) may improve general knowledge and reduce personal decisional conflict in patients with early stage papillary thyroid cancer (PTC), when compared to usual care. Patients with early stage PTC will be required to have surgical pathologic criteria for which adjuvant RAI treatment may be considered optional.
| Condition | Intervention | Phase |
|---|---|---|
|
Thyroid Cancer |
Other: Decision aid exposure |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Decision Aid on Radioactive Iodine Treatment for Early Stage Papillary Thyroid Cancer (Randomized Controlled Trial) |
Resource links provided by NLM:
Further study details as provided by University Health Network, Toronto:
Primary Outcome Measures:
- Knowledge about papillary thyroid cancer and radioactive iodine treatment [ Time Frame: Day 0 ] [ Designated as safety issue: No ]The knowledge questinnaire will be administered on the same day as the randomization visit (after the exposure to the decision aid for participants in the intervention group, or without exposure to the decision aid in the control group).
Secondary Outcome Measures:
- Decisional conflict (and subscale measures) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]The decisional conflict questinnaire will be administered on the same day as the randomization visit (after the exposure to the decision aid for participants in the intervention group, or without exposure to the decision aid in the control group).
- Decisional regret [ Time Frame: 6-12 months and 15-23 months ] [ Designated as safety issue: No ]Decisional regret will be assessed at least 6 months after the randomization, or later if the decision is not finalized at 6 months. The time frame should generally be about 6 - 12 months after the randomization visit. This outcome will also be evaluated at an extended follow-up study call at about 15-23 months
- Reasons for accepting or declining radioactive iodine treatment [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]Rationale for accepting or declining radioactive iodine treatment will be assessed 6 months after the randomization visit as well as after the decision on radioactive iodine has been finalized (generally decision should have been finalized within 12 months).
- The final decision to accept or decline adjuvant radioactive iodine treatment [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]The final decision to accept or decline adjuvant radioactive iodine treatment will be assessed 6 months after the randomization visit as well as after the decision on radioactive iodine has been finalized (generally decision should have been finalized within 12 months).
- Feeling informed about RAI treatment decision [ Time Frame: 15-23 months ] [ Designated as safety issue: No ]Questionnaire on feeling informed about a medical decision
- Feeling satisfied with RAI treatment decision [ Time Frame: 15-23 months ] [ Designated as safety issue: No ]Question on RAI decision satisfaction
- Cancer-related worry [ Time Frame: 15-23 months ] [ Designated as safety issue: No ]Assessment of Survivor Concerns questionnaire
- Trust in the treating physician [ Time Frame: 15-23 months ] [ Designated as safety issue: No ]Trust in Physician questionnaire
- Mood [ Time Frame: 15-23 months ] [ Designated as safety issue: No ]Depression and Anxiety Screen (PHQ-4) questionnaire
- Qualitative data [ Time Frame: 15-23 months ] [ Designated as safety issue: No ]In-depth interview, discussing RAI treatment decision-making, treatment satisfaction, and trial participation
- Cancer Impact [ Time Frame: 24 months or longer-post randomization ] [ Designated as safety issue: No ]Cancer Impact Questionnaire
- Information Needs [ Time Frame: 24 months or longer-post randomization ] [ Designated as safety issue: No ]Information Needs Questionnaire
- General Concerns [ Time Frame: 24 months or longer post-randomization ] [ Designated as safety issue: No ]General Concerns Questionnaire
- Cancer-related Worry [ Time Frame: 24 months or longer post-randomization ] [ Designated as safety issue: No ]Assessment of Survivor Concerns
| Estimated Enrollment: | 74 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DA intervention
Decision aid exposure + usual care
|
Other: Decision aid exposure
Exposure to a computerized decision aid on adjuvant radioactive iodine treatment decision-making. The exposure is during one visit.
|
|
No Intervention: Control
Usual care
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria for patient participants:
- Individuals with papillary thyroid carcinoma who have had complete resection of their thyroid at surgery (total or near-total thyroidectomy, or hemi- [subtotal] with completion thyroidectomy)on or after September 1, 2009
- Age at time of first thyroid cancer surgery must be at least 18 years or older
- The papillary thyroid cancer TNM pathologic stage must be pT1 or pT2, N0 (or Nx), M0 (or Mx) (TNM stage, AJCC VI) (ie. primary tumor size 1-4 cm, no known positive lymph nodes at the time of primary surgery, no extension of the tumor outside the thyroid, no venous or lymphatic invasion, and no known distant metastases at primary surgery, with no tall cell features, as per surgical pathology report)
- Must be able to communicate in spoken and written English
- Must be able to use a computer
- Must be able to provide informed consent on one's own (without any need for translation)
Exclusion criteria for patient participants:
- Participants not meeting inclusion criteria
- Concurrent diagnosis of medullary or anaplastic or poorly differentiated thyroid cancer or thyroid lymphoma
- Prior radioactive treatment for thyroid cancer
- Individuals who have been taken off their thyroid hormone for testing or treatment, will not be eligible for the study while off this medication.
- Individuals who are unwilling for investigators to confirm their pathologic stage of disease through review of pathology report(s) will be ineligible for the study
Inclusion criteria for the physician feedback component of this study:
- Physicians and surgeons caring for thyroid cancer patients, in active practice at University Health Network in Toronto, Ontario, Canada.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083550
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083550
Locations
| Canada, Ontario | |
| University Health Network | |
| Toronto, Ontario, Canada, M5G 2C4 | |
Sponsors and Collaborators
University Health Network, Toronto
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Investigators
| Principal Investigator: | Annie M Sawka, MD, PhD | University Health Network, Toronto |
| Study Director: | David P Goldstein, MD | University Health Network, Toronto |
More Information
Publications:
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01083550 History of Changes |
| Other Study ID Numbers: | REB 09-0986-BE UHNREB 09-0986-BE |
| Study First Received: | February 24, 2010 |
| Last Updated: | September 23, 2015 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University Health Network, Toronto:
|
thyroid carcinoma thyroid cancer therapeutic radioisotopes radioactive iodine |
Additional relevant MeSH terms:
|
Thyroid Diseases Thyroid Neoplasms Carcinoma Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Iodine Anti-Infective Agents, Local Anti-Infective Agents Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 29, 2016