Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Anna Sawka, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01083550
First received: February 24, 2010
Last updated: January 5, 2015
Last verified: January 2015

February 24, 2010
January 5, 2015
February 2010
December 2016   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01083550 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
  • participant satisfaction [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
    Participant satisfaction 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).
  • 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).
  • Physician satisfaction [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]
    Physician satisfaction will be assesed a few months before the trial ends, expected to be about 18 to 24 months after recruitment has started.
Not Provided
Not Provided
 
Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer
Decision Aid on Radioactive Iodine Treatment for Early Stage Papillary Thyroid Cancer (Randomized Controlled Trial)

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.

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.

15-23 Month Extended Follow-up Study: After initiation of the primary study above, we were subsequently awarded funding to contact the enrolled study participants about 15 and 23 months post-randomization to inquire for permission to participate in an extended follow-up study. The extended follow-up study was approved by the University Health Network Research Ethics Board. Participants from the original randomized controlled trial (above) are contacted by telephone for consent to participate in the extended follow-up study, which is considered exploratory (secondary).

The extended follow-up study includes a quantitative questionnaire telephone interview component and a qualitative component. For the quantitative questionnaire component, a single telephone interview is performed updating demographics, thyroid cancer outcomes/treatments (with confirmatory medical record review and administering quantitative questionnaires verbally. A participants consenting to the extended follow-up study are also offered the opportunity to participate in an in-depth qualitative study, involving a one-on in-person interview (which is audio-recorded, transcribed, and analyzed using qualitative methods). A representative subgroup of about 15-30 participants are invited in the qualitative interview and sampling continued until saturation of themes is achieved.

The following exploratory questions are to be addressed in the quantitative component of the extended follow-up study (about 15-23 months post-randomization):

  1. To what degree do participants in the study (decision aid and control groups) perceive themselves to be respectively informed and satisfied with the original radioactive iodine treatment decision? The results in respective study arms are compared.
  2. To what degree do participants in the study (decision aid and control groups) perceive themselves to regret their original radioactive iodine treatment decision? The results in respective study arms are compared.
  3. To what degree do participants in the study (decision aid and control groups) perceive current cancer-related worry (Assessment of Survivor Concerns Questionnaires)? The results in respective study arms are compared.
  4. To what degree do participants in the study (decision aid and control groups) perceive trust in their treating physician (Trust in Physician Scale)? The results in respective study arms are compared.
  5. How do participants in the study (decision aid and control groups) perceive their mood (PHQ-4 questionnaire)? The results in respective study arms are compared.

The qualitative subgroup study includes semi-structured questions on the experiences of radioactive iodine treatment decision-making, overall thyroid cancer treatment satisfaction, and study participation.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Thyroid Cancer
Other: Decision aid exposure
Exposure to a computerized decision aid on adjuvant radioactive iodine treatment decision-making. The exposure is during one visit.
  • Experimental: DA intervention
    Decision aid exposure + usual care
    Intervention: Other: Decision aid exposure
  • No Intervention: Control
    Usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
74
December 2016
December 2016   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01083550
REB 09-0986-BE, UHNREB 09-0986-BE
No
Anna Sawka, University Health Network, Toronto
University Health Network, Toronto
  • Ontario Ministry of Health and Long Term Care
  • Canadian Institutes of Health Research (CIHR)
Principal Investigator: Annie M Sawka, MD, PhD University Health Network, Toronto
Study Director: David P Goldstein, MD University Health Network, Toronto
University Health Network, Toronto
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP