Thyroid CancerNCT03300284
Decision Making and Psychological Outcomes in Low-Risk Papillary Thyroid Cancer
An observational study of Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
This study is being done to understand the decision-making process regarding management choice in low-risk papillary thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 186 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Aug 2017to 13 Jul 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted primarily in the MSK endocrinology and surgery clinics, which have a large volume of patients with LR-PTC choosing both surgery and AS. We also expect to expand this study to several clinics within the MSK Alliance Network and outside participating sites.
Who may be able to join
- Able to read, write, and communicate in English Patients who have been diagnosed with LR-PTC as described above
- For Aim 1, adults with recently diagnosed LR-PTC who have not yet made a choice between surgery and AS
- For Aim 2, adults with LR-PTC who made a decision about surgery or AS at least 3 months prior, but no more than 4 years prior to their routine follow-up visit at which they are being recruited for this study.
- Active patients of MSK and participating institutions
Who cannot join
- Patients who have been diagnosed with a tumor greater than 2 cm
- Patients with clinically suspicious lymphadenopathy in the neck
- Patients with evidence of gross ETE after a biopsy of the papillary thyroid tumor
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
MAIMONIDES MEDICAL CENTER (Data collection only)
Brooklyn, New York, 11220
Hartford Healthcare (Data Collection)
Hartford, Connecticut, 06102
Memorial Sloan Kettering Monmouth (Consent and Follow up)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
This study is being done to understand the decision-making process regarding management choice in low-risk papillary thyroid cancer.
- Conditions
- Thyroid Cancer
- Being tested
- Questionnaires
- Keywords
- Quality of Life, Decision Making, 17-382
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Quality of Life Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Thyroid cancer | This study does not involve any intervention, but rather data collection on patient and physician preferences and beliefs, communication, and patient psychological outcomes. Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
influencing decision making pre-visit
Patients will complete a pre-visit questionnaire and the patient-physician interaction during the visit will be recorded and subjected to qualitative analysis for extraction of variables representing the presence of elements of shared decision making and strength of physician influence.
Measured: 3 years
influencing decision making post-visit
Patients will complete a post-visit questionnaire, and the patient-physician interaction during the visit will be recorded and subjected to qualitative analysis for extraction of variables representing the presence of elements of shared decision making and strength of physician influence.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start7 Aug 2017
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Roman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300284
- Sponsor's protocol ID
- 17-382
- Status last verified
- Jul 2023
- First submitted
- 28 Sep 2017
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making and Psychological Outcomes in Low-Risk Papillary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT03300284
- Acronym / sponsor ID
- 17-382
- Conditions
- Thyroid Cancer
- Keywords
- Quality of Life, Decision Making, 17-382
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 3 Oct 2017 (actual)
- 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.
This study is being done to understand the decision-making process regarding management choice in low-risk papillary thyroid cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thyroid cancer | – | Behavioral: QuestionnairesThis study does not involve any intervention, but rather data collection on patient and physician preferences and beliefs, communication, and patient psychological outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted primarily in the MSK endocrinology and surgery clinics, which have a large volume of patients with LR-PTC choosing both surgery and AS. We also expect to expand this study to several clinics within the MSK Alliance Network and outside participating sites.
Key inclusion criteria (4 listed)
- Able to read, write, and communicate in English Patients who have been diagnosed with LR-PTC as described above
- For Aim 1, adults with recently diagnosed LR-PTC who have not yet made a choice between surgery and AS
- For Aim 2, adults with LR-PTC who made a decision about surgery or AS at least 3 months prior, but no more than 4 years prior to their routine follow-up visit at which they are being recruited for this study.
- Active patients of MSK and participating institutions
Key exclusion criteria (3 listed)
- Patients who have been diagnosed with a tumor greater than 2 cm
- Patients with clinically suspicious lymphadenopathy in the neck
- Patients with evidence of gross ETE after a biopsy of the papillary thyroid tumor
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 |
|---|---|---|
| QuestionnairesQuality of Life Questionnaires | Behavioural | Thyroid cancer |
Primary outcome
influencing decision making pre-visit
Time frame: 3 years
Patients will complete a pre-visit questionnaire and the patient-physician interaction during the visit will be recorded and subjected to qualitative analysis for extraction of variables representing the presence of elements of shared decision making and strength of physician influence.
influencing decision making post-visit
Time frame: 3 years
Patients will complete a post-visit questionnaire, and the patient-physician interaction during the visit will be recorded and subjected to qualitative analysis for extraction of variables representing the presence of elements of shared decision making and strength of physician influence.
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 Jul 2023.
- 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.
Benjamin Roman, MD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites 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, run by Memorial Sloan Kettering Cancer Center at 5 sites 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 4 inclusion and 3 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 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
influencing decision making pre-visit (time frame: 3 years). The study lists 2 primary outcomes in all. 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 Jul 2023.