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

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Cancer; Papillary Microcarcinoma
• Intervention / Treatment: Behavioral: Focus groups; Behavioral: Focus groups

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All participants will be recruited from Dr. Mike Tuttle's clinic.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients who have had surgery or have scheduled surgery; 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.	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; Other Names: Each focus group will last between approximately 90-120 minutes and each; individual interview will last approximately 60 minutes. Notes will be taken; during each focus group and individual interviews. All focus groups and; individual interviews, will be audio-recorded with digital voice recorders,; and the recordings will be transcribed by a professional transcription service,; for later qualitative analysis. Individual interviews will be offered to those; patients who are unable to attend a focus group due to scheduling conflicts or other reasons.; Participants interested in taking part in the optional member check will be mailed a summary; document created by the research team. A surgery group summary document will be mailed to; surgery patients and an active surveillance summary document will be mailed to active surveillance; patients. Each summary document will include data, analytic categories, interpretations, and; conclusions reached by the analytic team.; 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; Other Names: for later qualitative analysis. Individual interviews will be offered to those; Participants interested in taking part in the optional member check will be mailed a summary; document created by the research team. A surgery group summary document will be mailed to; surgery patients and an active surveillance summary document will be mailed to active surveillance; patients. Each summary document will include data, analytic categories, interpretations, and; conclusions reached by the analytic team.; Each focus group will last between approximately 90-120 minutes and each individual interview will; last approximately 60 minutes. All focus groups and individual interviews, will be audio-recorded; with digital voice recorders. Notes will be taken during each focus group and each individual interview; the recordings will be transcribed by, a professional transcription service,; patients who are unable to attend a focus group due to; scheduling conflicts or other reasons.
who chose to not have immediate surgery; 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.	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; Other Names: Each focus group will last between approximately 90-120 minutes and each; individual interview will last approximately 60 minutes. Notes will be taken; during each focus group and individual interviews. All focus groups and; individual interviews, will be audio-recorded with digital voice recorders,; and the recordings will be transcribed by a professional transcription service,; for later qualitative analysis. Individual interviews will be offered to those; patients who are unable to attend a focus group due to scheduling conflicts or other reasons.; Participants interested in taking part in the optional member check will be mailed a summary; document created by the research team. A surgery group summary document will be mailed to; surgery patients and an active surveillance summary document will be mailed to active surveillance; patients. Each summary document will include data, analytic categories, interpretations, and; conclusions reached by the analytic team.; 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; Other Names: for later qualitative analysis. Individual interviews will be offered to those; Participants interested in taking part in the optional member check will be mailed a summary; document created by the research team. A surgery group summary document will be mailed to; surgery patients and an active surveillance summary document will be mailed to active surveillance; patients. Each summary document will include data, analytic categories, interpretations, and; conclusions reached by the analytic team.; Each focus group will last between approximately 90-120 minutes and each individual interview will; last approximately 60 minutes. All focus groups and individual interviews, will be audio-recorded; with digital voice recorders. Notes will be taken during each focus group and each individual interview; the recordings will be transcribed by, a professional transcription service,; patients who are unable to attend a focus group due to; scheduling conflicts or other reasons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: July 8, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: focus group; 11-108
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Thyroid Neoplasms; Carcinoma, Papillary
• Other Study ID Numbers: 11-108