RECRUITING

TRAIL Study: Feasibility and Pilot

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Conditions

Thyroid NoduleThyroid NeoplasmsThyroid Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a pilot study to compare two ways of managing newly identified thyroid nodules that are likely to be cancerous based on ultrasound result and which under usual care would undergo immediate biopsy. The main goals of this pilot study are 1) compare anxiety at 6 months in each treatment arm using the validated instrument Anxiety-CA, 2) measure thyroid quality of life in each treatment arm Participants will be randomized to one of two groups: 1. immediate biopsy (usual care) 2. Active monitoring (serial ultrasound based monitoring and close clinical follow-up)

Official Title

ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot

Quick Facts

Study Start:2025-05-01
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06220656

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be ≥18 years of age.
  2. * Participants must be able and willing to provide informed consent or have a surrogate capable of providing same.
  3. * Participants must be absent of symptoms referable to the nodule: dysphagia or nodule physically visible and/or bothersome to patient.
  4. * Participants' thyroid nodule must have a TI-RADS rating of 4 or 5.
  5. * Participants thyroid nodule must be ≤2 cm in largest diameter.
  6. * Participants must be being considered for biopsy.
  7. * Participants with a prior history of papillary thyroid cancer are eligible.
  1. * Adults who are unable to provide informed consent.
  2. * Patients for whom biopsy is not a consideration.
  3. * Patients with a prior history of thyroid cancer other than papillary thyroid cancer.
  4. * Patients with a history of radiation to the neck.
  5. * Patients who are athyroidal (thyroid gland has been removed or patient has only lingual thyroid tissue).
  6. * Patients who have ultrasound evidence of one or more of the following:
  7. * Airway invasion of the nodule.
  8. * Nodule adjacency to/invading the recurrent nerve.
  9. * Extra-thyroidal invasion by the nodule.
  10. * Patients who have metastasis to cervical lymph nodes (confirmed by needle biopsy if ultrasound suspicious), distant metastases, if identified) testing not required, not usual care)
  11. * Patients who have already had a biopsy of the nodule being considered for inclusion in the study.
  12. * Participants must meet the eligibility requirements above and will be or have been approached about enrolling in the pilot study.
  13. * Participants must be willing to allow audio recorder presence and / or willing to be interviewed by the QRI team.
  14. * Staff must be willing to audio record their communications with patients about enrolling in the study.
  15. * Staff must be willing to participate in interviews with QRI team about their views of the study.

Contacts and Locations

Study Contact

Michaela M Geffert, BS
CONTACT
(603) 305-3529
michaela.m.geffert@hitchcock.org

Principal Investigator

Louise Davies, MD, MS
PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center

Study Locations (Sites)

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States

Collaborators and Investigators

Sponsor: Dartmouth-Hitchcock Medical Center

  • Louise Davies, MD, MS, PRINCIPAL_INVESTIGATOR, Dartmouth-Hitchcock Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01
Study Completion Date2027-06

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Thyroid Nodule
  • Thyroid Neoplasms
  • Thyroid Cancer