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Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University Health Network, Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01083550
First received: February 24, 2010
Last updated: August 9, 2011
Last verified: July 2011
  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: 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 ] [ 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.

  • 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).


Estimated Enrollment: 74
Study Start Date: February 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA intervention
Decision aid exposure
Other: Decision aid exposure
Exposure to a computerized decision aid on adjuvant radioactive iodine treatment decision-making. The exposure is during one visit.

Detailed Description:

A. Primary research question

In patients with early stage papillary thyroid cancer, does the administration of a computerized decision aid improve the score on a test of knowledge about early stage PTC and adjuvant RAI treatment, when compared to usual care? (The knowledge score is a sum of positive responses from a total of 10 true/false questions in a self-administered questionnaire, to be administered at the study visit, Q2A).

B. Secondary research questions

  1. In patients with early stage PTC, does the administration of a computerized decision aid reduce overall decisional conflict (as well as the following respective subscales - informed subscale, uncertainty subscale, and effective decision subscale), when compared to usual care? (Decisional Conflict questionnaire, DCS).
  2. In patients with early stage PTC, does the administration of a computerized decision aid, improve reduce decisional regret relating to RAI decision making after the final decision has been made? (Decision Regret Questionnaire, DRQ)
  3. In patients with early stage PTC, does the administration of a computerized decision aid, reduce the number of participants receiving adjuvant radioactive iodine treatment (analysis for all participants, as well as those who are not already on a waiting list for radioactive iodine treatment at the time of recruitment, respectively)?
  4. Do the respective monitoring or blunting scores on the Miller Behavioral Style Scale (MBSS) correlate with the number of clicks for information performed by participants reviewing the decision aid? (subgroup analysis in the decision aid intervention group)
  5. Do the respective monitoring or blunting scores on the Miller Behavioral Style Scale (MBSS) correlate with the score on a test of knowledge about early stage PTC and adjuvant RAI treatment? (Respective analyses planned for entire study population, as well as the intervention and control groups)
  6. What are the main reasons why RAI treatment is selected or not selected (after the decision has been finalized), grouping descriptions according to exposure or non-exposure to a computerized decision aid? (See Follow-up questionnaire [administered by telephone], question 2, qualitative description, with reasons to be coded and quantified using mixed methods).

NOTE: In the original design of this study, we hoped to utilize a modified Client Satisfaction Questionnaire for assessment of satisfaction of patient participants and physicians as secondary trial outcomes. However, we are unable to utilize any modified Client Satisfaction Questionnaires in this study, because of lack of permission from the original developer of the Client Satisfaction Questionnaire-8, who has copyrighted and trademarked the questionnaire and prohibits such modifications. No modified client satisfaction questionnaire results have been analyzed in this study and will not be analyzed.

Study design The project design will be a single-centre randomized controlled trial conducted at University Health Network. The participants will be randomized to a) the decision aid group (in addition to usual care [counseling by his or her physician, called usual care]) or b) usual care. The DA will be available only to participants during the study (not the public or treating physicians). The decision aid testing will be performed at the Toronto General Hospital.

  Eligibility

Ages Eligible for Study:   18 Years and older
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

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

No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Annie Sawka, Primary Investigator, University Health Network and University of 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: August 9, 2011
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:
Carcinoma
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2014