Back to resultsIntervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
Primary Purpose
Thyroid Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care
CQUPLE
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Cancer
Eligibility Criteria
Inclusion Criteria: Age 18 to 80 years Low risk papillary thyroid cancer or highly suspicious for cancer Low risk papillary thyroid cancer cT1-2: Tumor size 4 cm or smaller and limited to the thyroid on ultrasound cN0: No evidence of lymph node metastasis on ultrasound cM0: No evidence of distant metastasis on imaging Highly suspicious for cancer Cytology meeting Bethesda V or Bethesday III or IV with molecular testing indicating a 70% risk of greater of thyroid cancer Nodule size 4 cm and smaller Limited to the thyroid on ultrasound No evidence of suspicious lymph nodes No evidence of thyroid cancer outside of the neck Referred for surgical consultation. Exclusion Criteria: History of previous thyroid cancer or thyroid surgery and parathyroid surgery Non-English speaking Deaf Subject Selection (for Surgeons) Surgeon Inclusion Criteria Performs at least one thyroid surgery annually on adults Credentialed at Michigan Medicine Surgeon Exclusion Criteria None
Sites / Locations
- The University of Michigan Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CQUPLE Intervention
Usual Care Control
Arm Description
A novel intervention called CQUPLE (pronounced "couple"), which includes two interventions delivered together: (1) a Chart of side-by-side, evidence-based information comparing all three treatment options for low-risk thyroid cancer, including expected outcomes and (2) a Question Prompt List that contains key questions to consider asking the surgeon.
The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
Outcomes
Primary Outcome Measures
Acceptability of the CQUPLE intervention to patients
This 4-item quantitative instrument assesses participants' views on the acceptability of a novel intervention, such as CQUPLE. The response option are on a 5-point scale from 'completely disagree' to 'completely agree.' Scales are created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Interventional group only.
Acceptability of the CQUPLE intervention to providers
This 15-question quantitative instrument measures physician acceptability of decision support interventions with respect to ease of use and approach. Response options are on a 5-point Likert scale from 1 to 5 ('strongly disagree' to 'strongly agree'). Responses are reported descriptively in terms of proportions responding positively or negatively on each criterion.
Feasibility of the CQUPLE intervention (recruitment)
Recruitment rate will be defined as the number of patients who confirm eligibility during the screening process (they can be screened by phone or by questions in Qualtrics prior to consent) divided by the number who consent to participate.
Feasibility of the CQUPLE intervention (retention)
Retention will be defined as the number who complete the entire study (pre- and post-assessments) divided by the number consented.
Feasibility of the CQUPLE intervention (burden of data collection on study team)
To measure burden of data collection, the investigators will record the number of emails, texts, and phone calls needed for each participant to complete the measures.
Secondary Outcome Measures
Effect of CQUPLE on patient treatment choice
The investigators will assess patient's intended treatment choice at baseline and pre-visit. The investigators will assess actual treatment choice post-visit. The investigators will ask: "Knowing what you know now, which treatment option would/did you choose for yourself?" Answers will include: removal of the entire thyroid, removal of half of the thyroid, surveillance with ultrasound.
Full Information
NCT ID
NCT06073223
First Posted
September 26, 2023
Last Updated
October 3, 2023
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT06073223
Brief Title
Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
Official Title
Pilot Study of an Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study will include 50 patients newly diagnosed with low-risk thyroid cancer ranging from 18-80 years of age. After scheduling their surgeon visit, the investigators will enroll patients and measure their intended treatment choice, baseline awareness of the three treatment options, expected outcomes, self-efficacy, and activation. The participants will then be randomized 1:1 and deliver the CQUPLE intervention to the intervention group. The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit. The study team will repeat all measures prior to the surgical consult and after the surgical consult. The study team will record the patients' actual treatment choice after the consult.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The control group will be blinded to the intervention and receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CQUPLE Intervention
Arm Type
Experimental
Arm Description
A novel intervention called CQUPLE (pronounced "couple"), which includes two interventions delivered together: (1) a Chart of side-by-side, evidence-based information comparing all three treatment options for low-risk thyroid cancer, including expected outcomes and (2) a Question Prompt List that contains key questions to consider asking the surgeon.
Arm Title
Usual Care Control
Arm Type
Active Comparator
Arm Description
The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit.
Intervention Type
Other
Intervention Name(s)
CQUPLE
Intervention Description
Our research team developed a novel intervention called CQUPLE (pronounced "couple"), which includes two interventions delivered together: (1) a Chart of side-by-side, evidence-based information comparing all three treatment options for low-risk thyroid cancer, including expected outcomes and (2) a Question Prompt List that contains key questions to consider asking the surgeon. The intervention is grounded in social cognitive theory and aims to increase patient awareness of treatment options and their outcomes, patient activation, and self-efficacy for decision making.
Primary Outcome Measure Information:
Title
Acceptability of the CQUPLE intervention to patients
Description
This 4-item quantitative instrument assesses participants' views on the acceptability of a novel intervention, such as CQUPLE. The response option are on a 5-point scale from 'completely disagree' to 'completely agree.' Scales are created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Interventional group only.
Time Frame
day after clinic visit
Title
Acceptability of the CQUPLE intervention to providers
Description
This 15-question quantitative instrument measures physician acceptability of decision support interventions with respect to ease of use and approach. Response options are on a 5-point Likert scale from 1 to 5 ('strongly disagree' to 'strongly agree'). Responses are reported descriptively in terms of proportions responding positively or negatively on each criterion.
Time Frame
at time of surgery
Title
Feasibility of the CQUPLE intervention (recruitment)
Description
Recruitment rate will be defined as the number of patients who confirm eligibility during the screening process (they can be screened by phone or by questions in Qualtrics prior to consent) divided by the number who consent to participate.
Time Frame
up to 7 days after surgery
Title
Feasibility of the CQUPLE intervention (retention)
Description
Retention will be defined as the number who complete the entire study (pre- and post-assessments) divided by the number consented.
Time Frame
up to 7 days after surgery
Title
Feasibility of the CQUPLE intervention (burden of data collection on study team)
Description
To measure burden of data collection, the investigators will record the number of emails, texts, and phone calls needed for each participant to complete the measures.
Time Frame
up to 7 days after surgery
Secondary Outcome Measure Information:
Title
Effect of CQUPLE on patient treatment choice
Description
The investigators will assess patient's intended treatment choice at baseline and pre-visit. The investigators will assess actual treatment choice post-visit. The investigators will ask: "Knowing what you know now, which treatment option would/did you choose for yourself?" Answers will include: removal of the entire thyroid, removal of half of the thyroid, surveillance with ultrasound.
Time Frame
baseline, pre-visit and post visit- up to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 to 80 years
Low risk papillary thyroid cancer or highly suspicious for cancer
Low risk papillary thyroid cancer
cT1-2: Tumor size 4 cm or smaller and limited to the thyroid on ultrasound
cN0: No evidence of lymph node metastasis on ultrasound
cM0: No evidence of distant metastasis on imaging
Highly suspicious for cancer
Cytology meeting Bethesda V or Bethesday III or IV with molecular testing indicating a 70% risk of greater of thyroid cancer
Nodule size 4 cm and smaller
Limited to the thyroid on ultrasound
No evidence of suspicious lymph nodes
No evidence of thyroid cancer outside of the neck
Referred for surgical consultation.
Exclusion Criteria:
History of previous thyroid cancer or thyroid surgery and parathyroid surgery
Non-English speaking
Deaf
Subject Selection (for Surgeons)
Surgeon Inclusion Criteria
Performs at least one thyroid surgery annually on adults
Credentialed at Michigan Medicine
Surgeon Exclusion Criteria
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katy Jensen
Phone
734-764-5424
Email
gensurgadmin-choiceresearchteam@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Pitt
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katy Jensen
Phone
734-764-5424
Email
gensurgadmin-choiceresearchteam@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Susan Pitt, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators will make de-identified data available on a by request basis and will require a DUA
IPD Sharing Time Frame
A data set comprised of survey data, interview and conversation transcripts, and metadata will be made available for non-profit research purposes within one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier.
IPD Sharing Access Criteria
The data set will be made available to external investigators and the public on a case-by-case basis, to be approved by the PI and in accordance with institutional, HIPAA, state and federal regulations. A data-sharing agreement may be instituted, depending upon the data to be shared.
Learn more about this trial
Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer
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