Treatment Decision-Making Among Patients Diagnosed With Papillary Microcarcinoma and Their Significant Others

Thyroid Cancer Clinical Trial

Official title:

Treatment Decision-Making Among Patients Diagnosed With Papillary Microcarcinoma and Their Significant Others

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392222
• Other study ID #: 11-108
• Status: Completed
• Phase: N/A
• First received: June 29, 2011
• Last updated: June 20, 2017
• Start date: June 2011
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to understand more about why some patients choose to have surgery to treat their papillary microcarcinoma (PMC) and others choose to have their papillary microcarcinoma (PMC) regularly watched by their doctor to see if and when they may need surgery (referred to as "active surveillance"). The investigators also hope learn more about what patients and their family members worry about or feel they will gain from surgery or active surveillance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Thyroid cancer patient eligibility will include:

• Thyroid cancer patients who have been diagnosed with papillary microcarcinoma (or subcentimeter thyroid lesions with fine needle aspiration biopsy suspicious for papillary or follicular thyroid cancer) within the prior 6-12 months as per EMR path report and clinician assessment;

• Presented with the option of treating their papillary microcarcinomas with either surgery or active surveillance as per treating physician;

• English-fluent;

• 18 years of age or older;

Patient-designated significant other eligibility will include:

• Nomination by patient as individual who assisted patient in decision-making regarding how to treat thyroid papillary microcarcinoma;

• English-fluent;

• 18 years of age or older;

Exclusion Criteria:

Thyroid cancer patient exclusion criteria will include:

• Thyroid cancer patients with known loco-regional or distant metastases prior to initial surgical intervention as per path report.

Related Conditions & MeSH terms

• Papillary Microcarcinoma
• Thyroid Cancer
• Thyroid Neoplasms

Intervention

Behavioral:
• Focus groups
The focus groups will cover the following issues Perceptions of thyroid cancer and disease status Sources of information used in papillary microcarcinoma treatment decision-making Treatment decision-making processes and influential factors Perceived barriers to active surveillance to treat papillary microcarcinoma (for the immediate surgery sub-sample) Perceived facilitators to active surveillance to treat papillary microcarcinoma (for the non-immediate surgery sub-sample) Views about how to improve acceptability of active surveillance as a disease management option
• Focus groups
The focus groups will cover the following issues: Perceptions of thyroid cancer and disease status Sources of information used in papillary microcarcinoma treatment decision-making Treatment decision-making processes and influential factors Perceived barriers to active surveillance to treat papillary microcarcinoma (for the immediate surgery sub-sample) Perceived facilitators to active surveillance to treat papillary microcarcinoma (for the non-immediate surgery sub-sample) Views about how to improve acceptability of active surveillance as a disease management option

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To explore patients' and families' perceived risks and benefits of active surveillance and surgery within the context of papillary microcarcinoma.	We'll conduct focus groups & individual interviews with 2 population segments established by the method of Krueger & Casey & Morgan. The population segments will be thyroid cancer patients who have had surg or have scheduled surg, & any pt-designated significant others who assisted pts with tx decision-making & thyroid cancer pts who chose to not have immediate surg, whether they are either postponing their tx decision until a later date, or have committed to active surveillance rather than surg, & any pt-designated significant others who assisted these patients with tx decision-making.	5 years
Secondary	To examine the factors in patients' and families' decision making about the treatment of papillary microcarcinoma.	We'll conduct focus groups & individual interviews with 2 population segments established by the method of Krueger & Casey & Morgan. The population segments will be thyroid cancer pts who have had surg or have scheduled surg, & any pt-designated significant others who assisted patients with tx decision-making & thyroid cancer pts who chose to not have immediate surg, whether they are either postponing their tx decision until a later date, or have committed to active surveillance rather than surg, & any patient-designated significant others who assisted these pts with tx decision-making.	5 years

External Links

•   Memorial Sloan Kettering Cancer Center