Health and Wellness Coaching to Improve Adherence to Healthy Habits and Treatment Plans in Papillary and Follicular Thyroid Cancer Survivors

April 22, 2026 updated by: Mayo Clinic

Health and Wellness Coaching to Improve Patient Activation and Adherence to Healthy Habits in Differentiated Thyroid Cancer Care: A Mixed-Methods Pilot Study

This clinical trial evaluates the impact of a patient-centered health and wellness coaching (HWC) intervention on adherence to treatment plans and healthy lifestyle practices in patients with papillary or follicular thyroid cancer. Treatment for thyroid cancer often involves surgery, radioactive iodine and/or lifelong levothyroxine with regular monitoring of thyroid stimulating hormone levels. Despite strong survival rates, patients frequently report fatigue, cognitive issues, mood changes, and disruptions in daily life. Treatment burden and psychosocial strain often impair the ability to follow the treatment plan and healthy lifestyle. Studies have shown that HWC motivates patients to take ownership and accountability to perform positive and healthy behavioral changes. HWC may have a positive impact on health-related goal-setting processes and improve self-care and healthcare outcomes in certain settings. It is not yet known how HWC impacts thyroid cancer patients. Incorporating HWC into survivorship care may improve adherence to treatment plans and healthy lifestyle practices in patients with papillary or follicular thyroid cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Megan Warner
  • Phone Number: 904-953-0476

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
        • Contact:
        • Contact:
          • Megan Warner
          • Phone Number: 904-953-0476
        • Principal Investigator:
          • Abd Moain Abu Dabrh, MB, BCh, MS

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults ≥ 18 years
  • Histologically confirmed papillary or follicular thyroid carcinoma
  • Status post total thyroidectomy ± radioactive iodine therapy
  • Receiving levothyroxine monotherapy (no triiodothyronine [T3] or desiccated thyroid products)
  • Thyroid-stimulating hormone (TSH) < 4 uIU/mL at ≥ 3 months post-thyroidectomy
  • English proficiency
  • Ability to provide informed consent

Exclusion Criteria:

  • Medullary or anaplastic thyroid carcinoma
  • Current systemic therapy for thyroid or other cancers
  • Cognitive or psychiatric impairment precluding participation
  • Inability to complete study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive care (HWC)
Patients attend an initial HWC session over 60 minutes and then attend follow-up HWC sessions over 20-60 minutes each monthly for up to 5 months.
Other: Questionnaire Administration
Ancillary studies
Other: Interview
Ancillary studies
Other: Counseling
Attend HWC sessions
Other Names:
  • Counseling Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Up to 1 year
Assessed by the number enrolled out of the number of eligible participants approached
Up to 1 year
Retention rate
Time Frame: At 6 months
Assessed by the number of participants who complete follow-up sessions
At 6 months
Session completion rates
Time Frame: Up to 6 months
Assessed by the number of sessions attended (out of 6). Success is defined as attendance at ≥ 4 of 6 sessions attended.
Up to 6 months
Study completion rate
Time Frame: At baseline and at 6 months
Assessed by the number of participants who complete study compared to the number of participants lost to-follow-up.
At baseline and at 6 months
Intervention fidelity
Time Frame: Up to 6 months
Assessed by the number of sessions that meet ≥ 80% of checklist-defined core elements
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in LMWPHI score
Time Frame: At baseline and at 6 months
The Lifestyle Medicine Whole Person Health Index (LMWPHI) is a self-report questionnaire used to track lifestyle health. The questionnaire consists of 30 questions categorized under 5 areas: nutrition, movement, sleep/stress, substance use, and connection. Questions are Total scores range from 0- 50 with higher scores indicating better overall lifestyle health
At baseline and at 6 months
Rate of adherence to medication schedule
Time Frame: Up to 6 months
Assessed using the Medication Adherence Report Scale-5 (MARS-5), which consists of 5 questions answered on a scale of 1 (always) to 5 (never). Higher scores indicate better adherence to medication schedule.
Up to 6 months
Self-reported rate of adherence to lifestyle care plan
Time Frame: Up to 6 months
Assessed by self-report during health and wellness coaching (HWC) sessions and exit interview. Lifestyle care plan will be developed at baseline HWC session. Coach will partner with participant to establish person-centered wellness vision with specific goals to support healthy living. Adherence will be assessed at follow-up sessions (1-2 sessions monthly; up to 60 minutes total per month).
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Abd Moain Abu Dabrh, MB, BCh, MS, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Estimated)

May 26, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-011068
  • BeWell360 (Other Identifier: Mayo Clinic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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