Overview

This trial is active, not recruiting.

Conditions thyroid cancer, papillary microcarcinoma
Treatments focus groups
Sponsor Memorial Sloan Kettering Cancer Center
Start date June 2011
End date June 2017
Trial size 60 participants
Trial identifier NCT01392222, 11-108

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model family-based
Time perspective prospective
Arm
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.
focus groups Each focus group will last between approximately 90-120 minutes and each
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
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.
focus groups Each focus group will last between approximately 90-120 minutes and each individual interview will
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

Primary Outcomes

Measure
To explore patients' and families' perceived risks and benefits of active surveillance and surgery within the context of papillary microcarcinoma.
time frame: 5 years

Secondary Outcomes

Measure
To examine the factors in patients' and families' decision making about the treatment of papillary microcarcinoma.
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Treatment Decision-Making Among Patients Diagnosed With Papillary Microcarcinoma and Their Significant Others
Principal investigator Smita Banerjee, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.