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

Completed

• Conditions: Thyroid Cancer; Papillary Microcarcinoma
• Interventions: Behavioral: Focus groups

• Registration Number: NCT01392222
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-07-08
• Study First Posted: 2011-07-12
• Status Verified: 2017-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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;

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients who have had surgery or have scheduled surgery	Focus groups	In this exploratory study we will conduct focus groups and individual interviews with two population segments according to the established methodology of Krueger and Casey \[13\] and Morgan \[14\]. We will conduct 4-6 focus groups, two to three within each population segment, to evaluate the process of decision-making to manage papillary microcarcinoma, factors that influenced decision-making, understanding of risk for recurrence and other negative outcomes due to thyroid cancer, information needed to make informed decisions, and what could influence thyroid cancer patients who have had surgery or have scheduled to have surgery to remove their papillary microcarcinomas to consider active surveillance. Individual interviews will be offered and conducted as needed for those patients who are unable to attend a focus group due to scheduling conflicts or other reasons.
who chose to not have immediate surgery	Focus groups	In this exploratory study we will conduct focus groups with two population segments according to the established methodology of Krueger and Casey \[13\] and Morgan \[14\]. We will conduct 4-6 focus groups, two to three within each population segment, to evaluate the process of decision-making to manage papillary microcarcinoma, factors that influenced decision-making, understanding of risk for recurrence and other negative outcomes due to thyroid cancer, information needed to make informed decisions, and what could influence thyroid cancer patients who have had surgery or have scheduled to have surgery to remove their papillary microcarcinomas to consider active surveillance. Individual interviews will be offered and conducted as needed for those patients who are unable to attend a focus group due to scheduling conflicts or other reasons.

Primary Outcome Measures

Name	Time	Method
To explore patients' and families' perceived risks and benefits of active surveillance and surgery within the context of papillary microcarcinoma.	5 years	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.

Secondary Outcome Measures

Name	Time	Method
To examine the factors in patients' and families' decision making about the treatment of papillary microcarcinoma.	5 years	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States