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

NCT01392222 | Completed

• 1 other identifier: 11-108
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer; Papillary Microcarcinoma

Keywords

focus group; 11-108

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  5 years

Study Arms (2)

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

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

Interventions

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

Also known as: 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.

patients who have had surgery or have scheduled surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;
• 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;
• years of age or older;

You may not qualify if:

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Thyroid Neoplasms; Papillary Thyroid Microcarcinoma

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Smita Banerjee, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 12, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 21, 2017

Record last verified: 2017-06

Locations

US (1)