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

June 20, 2017 updated by: Memorial Sloan Kettering Cancer Center
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11-108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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