NCT01083550

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

6.8 years

First QC Date

February 24, 2010

Last Update Submit

November 28, 2016

Conditions

Thyroid Cancer

Keywords

thyroid carcinomathyroid cancertherapeutic radioisotopesradioactive iodine

Outcome Measures

Primary Outcomes (1)

  • Knowledge about papillary thyroid cancer and radioactive iodine treatment

    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).

    Day 0

Secondary Outcomes (14)

  • Decisional conflict (and subscale measures)

    Day 0

  • Decisional regret

    6-12 months and 15-23 months

  • Reasons for accepting or declining radioactive iodine treatment

    6 - 12 months

  • The final decision to accept or decline adjuvant radioactive iodine treatment

    6-12 months

  • Feeling informed about RAI treatment decision

    15-23 months

  • +9 more secondary outcomes

Study Arms (2)

DA intervention

EXPERIMENTAL

Decision aid exposure + usual care

Other: Decision aid exposure

Control

NO INTERVENTION

Usual care

Interventions

Decision aid exposureOTHER

Exposure to a computerized decision aid on adjuvant radioactive iodine treatment decision-making. The exposure is during one visit.

DA intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • \- Physicians and surgeons caring for thyroid cancer patients, in active practice at University Health Network in Toronto, Ontario, Canada.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (6)

  • 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.

    PMID: 20659341BACKGROUND

  • 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.

    PMID: 26169592BACKGROUND

  • 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.

    PMID: 22753906RESULT

  • 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. No abstract available.

    PMID: 23009127RESULT

  • 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.

    PMID: 26195199RESULT

  • 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.

    PMID: 26088605RESULT

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Annie M Sawka, MD, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • David P Goldstein, MD

    University Health Network, Toronto

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2010

First Posted

March 9, 2010

Study Start

February 1, 2010

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 29, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data

Locations

CA(1)