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NCT Number: NCT07545837

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

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.

Recruiting

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Key information

Conditions

Thyroid Gland Follicular Carcinoma Adenocarcinoma Adenocarcinoma, Follicular Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Gland Papillary Carcinoma Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location status: Recruiting

Location contact

Abd Moain Abu Dabrh, MB, BCh, MS

PRINCIPAL_INVESTIGATOR

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Megan Warner

CONTACT

904-953-0476

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling

Other

Attend HWC sessions

Other names: Counseling Intervention

interview

Other

Ancillary studies

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Recruitment rate

    Time frame: Up to 1 year

    Assessed by the number enrolled out of the number of eligible participants approached

  2. Retention rate

    Time frame: At 6 months

    Assessed by the number of participants who complete follow-up sessions

  3. 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.

  4. 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.

  5. Intervention fidelity

    Time frame: Up to 6 months

    Assessed by the number of sessions that meet ≥ 80% of checklist-defined core elements

Secondary outcomes

  1. 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.

  2. 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).

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Megan Warner

CONTACT

904-953-0476

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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