Thyroid CancerNCT01392222
Treatment Decision-Making Among Patients Diagnosed With Papillary Microcarcinoma and Their Significant Others
An observational study of Thyroid Cancer and Papillary Microcarcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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"). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Cancer, Papillary Microcarcinoma
- What is being tested?
- Focus groups
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All participants will be recruited from Dr. Mike Tuttle's clinic.
Who may be able to join
- 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:
Show all 9Show fewer
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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
- Being tested
- Focus groups
- Keywords
- focus group, 11-108
- Medical subject headings
- Thyroid Neoplasms, Papillary Thyroid Microcarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupsBehavioural
Also called 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,
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
Focus groupsBehavioural
Also called 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,
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Smita Banerjee, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392222
- Sponsor's protocol ID
- 11-108
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2011
- Last updated
- 21 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Decision-Making Among Patients Diagnosed With Papillary Microcarcinoma and Their Significant Others
- ClinicalTrials.gov ID
- NCT01392222
- Acronym / sponsor ID
- 11-108
- Conditions
- Thyroid Cancer, Papillary Microcarcinoma
- Keywords
- focus group, 11-108
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who have had surgery or have scheduled surgery | – | Behavioral: Focus groupsIn 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. |
| who chose to not have immediate surgery | – | Behavioral: Focus groupsIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will be recruited from Dr. Mike Tuttle's clinic.
Key inclusion criteria (9 listed)
- 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;
- Nomination by patient as individual who assisted patient in decision-making regarding how to treat thyroid papillary microcarcinoma;
Key exclusion criteria (2 listed)
- Thyroid cancer patients with known loco-regional or distant metastases prior to initial surgical intervention as per path report.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groupsAlso: 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,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 | Behavioural | patients who have had surgery or have scheduled surgery |
| Focus groupsAlso: 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,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 | Behavioural | who chose to not have immediate surgery |
Primary outcome
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.
1 secondary outcome
To examine the factors in patients' and families' decision making about the treatment of papillary microcarcinoma.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Smita Banerjee, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer and Papillary Microcarcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.