Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HUM00218043 | Other Identifier | University of Michigan | |
| R03CA283105 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CQUPLE Intervention | Experimental | 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. |
|
| Usual Care Control | Active Comparator | The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Other | The control group will receive usual care, which involves providing no disease or treatment specific information outside the surgeon visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 14 days after visit |
| 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. | at 6 months, and 2 years |
| 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. | up to 7 days after surgery |
| 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. | up to 7 days after surgery |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Age 18 to 80 years
Low risk papillary thyroid cancer or highly suspicious for cancer
Low risk papillary thyroid cancer
Highly suspicious for cancer
Referred for surgical consultation.
Exclusion Criteria:
Subject Selection (for Surgeons)
Surgeon Inclusion Criteria
Surgeon Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan Pitt | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | United States |
The investigators will make de-identified data available on a by request basis and will require a DUA
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.
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.
Not provided
Not provided
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| CQUPLE | Other | 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. |
|
| up to 7 days after surgery |
| baseline, pre-visit and post visit- up to 7 days |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |