This pilot research study evaluates factors influencing decision making and psychological outcomes in patients with low-risk papillary thyroid cancer. Patients diagnosed with low-risk papillary thyroid cancer can be treated with surgery to remove the thyroid or with active surveillance. The decision whether to have surgery or active surveillance is made by the treating physician and patient during consultation. Collecting and distributing psychological outcomes data to patients and providers may fill a knowledge gap and influence decision making.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03300284.
PRIMARY OBJECTIVES:
I. To evaluate factors influencing decision making regarding initial management of low-risk papillary thyroid cancer (LR-PTC), including physician and patient beliefs as well as aspects of patient-physician communication in terms of shared decision making and physician influence. (Aim I)
II. To evaluate psychological outcomes of patients who have chosen active surveillance (AS) or surgery for LR-PTC. (Aim II)
OUTLINE:
AIM I: In-person audio-recording of patient-physician interaction of decision for AS versus surgery is completed.
AIM II: Beginning 3 months prior, but no more than 4 years prior to their routine follow up visit, patients who have made a decision about surgery or AS receive questionnaires regarding their decision, re-assessing worry and examining other psychological outcomes (decisional regret, decisional conflict, intolerance of uncertainty, quality of life, perceived cancer risk, satisfaction with decision and medical maximizer-minimizer score [MMS]).
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorBenjamin R. Roman
