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Recruiting NCT07545837

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

No phase Interventional Thyroid Gland Follicular Carcinoma Thyroid Gland Papillary Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Counseling, Interview, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Thyroid Gland Follicular Carcinoma, Thyroid Gland Papillary Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Counseling
    Attend HWC sessions
  • Other Interview
    Ancillary studies
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • Recruitment rate [Time frame: Up to 1 year]
  • Retention rate [Time frame: At 6 months]
  • Session completion rates [Time frame: Up to 6 months]
  • Study completion rate [Time frame: At baseline and at 6 months]
  • Intervention fidelity [Time frame: Up to 6 months]
Secondary outcome measures (3)
  • Rate of adherence to medication schedule [Time frame: Up to 6 months]
  • Self-reported rate of adherence to lifestyle care plan [Time frame: Up to 6 months]
  • Change in LMWPHI score [Time frame: At baseline and at 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT07545837 · 25-011068 · BeWell360

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗