Patient Decision Aid in Supporting Decision-Making About When to Start or Stop New Drugs, Join Clinical Trials, or Continue Active Surveillance in Patients With Medullary Thyroid Cancer and Their Caregivers

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Thyroid Gland Medullary Carcinoma

Treatments: Other: Questionnaire Administration; Other: Decision Aid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03892993

NCI-2019-00631 (Registry Identifier)

2018-0557 (Other Identifier)

Details and patient eligibility

About

This trial develops and studies how well a patient decision aid works in supporting decision-making about when to start or stop new drugs, join clinical trials, or continue active cancer monitoring for patients with medullary thyroid cancer and their caregivers. Developing a patient decision aid may help patients with medullary thyroid cancer make well-informed decisions about their cancer care and be able to discuss their preferences with their doctors.

Full description

PRIMARY OBJECTIVES:

I. To assess patient/survivor, caregiver/family member, and provider decision-making needs.

II. To design and develop an initial patient decision aid prototype. III. To pilot test its acceptability. IV. To evaluate the acceptability and usability of the decision aid prototype from patients/survivors, caregivers and providers in a real world environment.

OUTLINE:

Participants use decision aid and complete questionnaire.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 18 years old or older
• Have or will face(d) this decision, including: Patient/survivor - who has medullary thyroid carcinoma, as determined by a clinician or documented in the Genetics of Endocrine Neoplasia Registry or sporadic (medullary thyroid carcinoma) MTC database; Caregiver/family member - of patient/survivor who has medullary thyroid carcinoma, as nominated by the patient/survivor; and Provider - who treats patients/survivors who have medullary thyroid carcinoma, as described above
• Able to speak, read, and write English
• Pregnant patients are included

Exclusion criteria

--Individuals with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in the registry)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Supportive care (decision aid)

Experimental group

Description:

Participants use decision aid and complete questionnaires.

Treatment:

Other: Decision Aid

Other: Questionnaire Administration