Thyroid Gland Follicular Carcinoma, Thyroid Gland Papillary Carcinoma
Conditions
Brief summary
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
OTHERCounseling
Attend HWC sessions
OTHERInterview
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | Up to 1 year | Assessed by the number enrolled out of the number of eligible participants approached |
| Retention rate | At 6 months | Assessed by the number of participants who complete follow-up sessions |
| Session completion rates | 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. |
| Study completion rate | 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. |
| Intervention fidelity | Up to 6 months | Assessed by the number of sessions that meet ≥ 80% of checklist-defined core elements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adherence to medication schedule | 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. |
| Self-reported rate of adherence to lifestyle care plan | 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). |
| Change in LMWPHI score | 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 |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
CONTACTMegan Warner
PRINCIPAL_INVESTIGATORAbd Moain Abu Dabrh, MB, BCh, MS
Mayo Clinic
Outcome results
None listed