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.

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Papillary Microcarcinoma Papillary Thyroid Microcarcinoma Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Focus Groups

Behavioral

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.

Primary outcomes

To explore patients' and families' perceived risks and benefits of active surveillance and surgery within the context of papillary microcarcinoma.

Time frame: 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 outcomes

To examine the factors in patients' and families' decision making about the treatment of papillary microcarcinoma.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2017
Study completion: 2017
First posted: Jul 12, 2011
Registry last updated: Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed