About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Medullary or anaplastic thyroid carcinoma
Current systemic therapy for thyroid or other cancers
Cognitive or psychiatric impairment precluding participation
Inability to complete study procedures
Trial design
Single group
Treatments tested in this trial
Counseling
Other interventionAttend HWC sessions
Interview
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
Recruitment rate
Assessed by the number enrolled out of the number of eligible participants approached
Retention rate
Assessed by the number of participants who complete follow-up sessions
Session completion rates
Assessed by the number of sessions attended (out of 6). Success is defined as attendance at ≥ 4 of 6 sessions attended.
Study completion rate
Assessed by the number of participants who complete study compared to the number of participants lost to-follow-up.
Secondary outcomes
Rate of adherence to medication schedule
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
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
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
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