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Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01083550
First Posted: March 9, 2010
Last Update Posted: November 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    The knowledge questionnaire 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 ]
    The decisional conflict questionnaire 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 ]
    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 ]
    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 ]
    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 ]
    Questionnaire on feeling informed about a medical decision

  • Feeling satisfied with RAI treatment decision [ Time Frame: 15-23 months ]
    Question on RAI decision satisfaction

  • Cancer-related worry [ Time Frame: 15-23 months ]
    Assessment of Survivor Concerns questionnaire

  • Trust in the treating physician [ Time Frame: 15-23 months ]
    Trust in Physician questionnaire

  • Mood [ Time Frame: 15-23 months ]
    Depression and Anxiety Screen (PHQ-4) questionnaire

  • Qualitative data [ Time Frame: 15-23 months ]
    In-depth interview, discussing RAI treatment decision-making, treatment satisfaction, and trial participation

  • Cancer Impact [ Time Frame: 24 months or longer-post randomization ]
    Cancer Impact Questionnaire

  • Information Needs [ Time Frame: 24 months or longer-post randomization ]
    Information Needs Questionnaire

  • General Concerns [ Time Frame: 24 months or longer post-randomization ]
    General Concerns Questionnaire

  • Cancer-related Worry [ Time Frame: 24 months or longer post-randomization ]
    Assessment of Survivor Concerns


Enrollment: 74
Study Start Date: February 2010
Study Completion Date: November 2016
Primary Completion Date: November 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Sawka AM, Straus S, Rotstein L, Brierley JD, Tsang RW, Asa S, Segal P, Kelly C, Zahedi A, Freeman J, Solomon P, Anderson J, Thorpe KE, Gafni A, Rodin G, Goldstein DP. Randomized controlled trial of a computerized decision aid on adjuvant radioactive iodine treatment for patients with early-stage papillary thyroid cancer. J Clin Oncol. 2012 Aug 10;30(23):2906-11. doi: 10.1200/JCO.2011.41.2734. Epub 2012 Jul 2.
Sawka AM, Rilkoff H, Tsang RW, Brierley JD, Rotstein L, Ezzat S, Asa SL, Segal P, Kelly C, Zahedi A, Gafni A, Goldstein DP. The rationale of patients with early-stage papillary thyroid cancer for accepting or rejecting radioactive iodine remnant ablation. Thyroid. 2013 Feb;23(2):246-7. doi: 10.1089/thy.2012.0422.
Sawka AM, Straus S, Rodin G, Heus L, Brierley JD, Tsang RW, Rotstein L, Ezzat S, Segal P, Gafni A, Thorpe KE, Goldstein DP. Thyroid cancer patient perceptions of radioactive iodine treatment choice: Follow-up from a decision-aid randomized trial. Cancer. 2015 Oct 15;121(20):3717-26. doi: 10.1002/cncr.29548. Epub 2015 Jul 20.
Sawka AM, Straus S, Rodin G, Tsang RW, Brierley JD, Rotstein L, Segal P, Gafni A, Ezzat S, Goldstein DP. Exploring the relationship between patients' information preference style and knowledge acquisition process in a computerized patient decision aid randomized controlled trial. BMC Med Inform Decis Mak. 2015 Jun 19;15:48. doi: 10.1186/s12911-015-0168-0.
Sawka AM, Straus S, Brierley JD, Tsang RW, Rotstein L, Rodin G, Gafni A, Ezzat S, Thabane L, Thorpe KE, Goldstein DP. Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer--a randomized controlled trial. Trials. 2010 Jul 26;11:81. doi: 10.1186/1745-6215-11-81.
Sawka AM, Straus S, Rodin G, Thorpe KE, Ezzat S, Gafni A, Goldstein DP. Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer: update to study protocol with follow-up extension. Trials. 2015 Jul 14;16:302. doi: 10.1186/s13063-015-0819-6.

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 ( Other Identifier: University Health Network Research Ethics Board Number )
First Submitted: February 24, 2010
First Posted: March 9, 2010
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual participant data

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


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