CClinicalTrials.gg
Sign In
CompletedNCT03300284Updated Jul 21, 2023

Decision Making and Psychological Outcomes in Low-Risk Papillary Thyroid Cancer

An observational study in Thyroid Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-21.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
186
Ages
18 Years and older
Sex
All
01

Study summary

This study is being done to understand the decision-making process regarding management choice in low-risk papillary thyroid cancer.

02

Conditions studied

  • Thyroid Cancer

Keywords

  • Quality of Life
  • Decision Making
  • 17-382
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
186 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Behavioral: Questionnaires

Interventions

  • BehavioralQuestionnaires

    Quality of Life Questionnaires

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

  2. 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.

    Time frame: 3 years

06

Study locations

5 sites
  • Hartford Healthcare (Data Collection)
    Hartford, Connecticut 06102, United States
  • Memorial Sloan Kettering Monmouth (Consent and Follow up)
    Middletown, New Jersey 07748, United States
  • MAIMONIDES MEDICAL CENTER (Data collection only)
    Brooklyn, New York 11220, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Lehigh Valley Health Network
    Allentown, Pennsylvania 18103, United States
07

References and documents

08

Registry details

Key details

Study ID
NCT03300284
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Oct 3, 2017
Start date
Aug 7, 2017
Primary completion
Jul 13, 2023
Completion
Jul 13, 2023
Last update
Jul 21, 2023

Study contacts

Benjamin Roman, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Thyroid Neoplasms→

Other studies from this sponsor

Memorial Sloan Kettering Cancer Center

Start the discussion