Health and Wellness Coaching to Improve Patient Activation and Adherence to Healthy Habits in Differentiated Thyroid Cancer Care: A Mixed-Methods Pilot Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Recruitment rate
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Interview (Other)
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.
Intervention: Counseling (Other)
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.
Intervention: Questionnaire Administration (Other)
Outcomes
Primary Outcomes
Recruitment rate
Time Frame: Up to 1 year
Assessed by the number enrolled out of the number of eligible participants approached
Retention rate
Time Frame: At 6 months
Assessed by the number of participants who complete follow-up sessions
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.
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.
Intervention fidelity
Time Frame: Up to 6 months
Assessed by the number of sessions that meet ≥ 80% of checklist-defined core elements
Secondary Outcomes
- Adherence to medication schedule(Up to 6 months)
- Adherence to lifestyle care plan(Baseline; 1-2 sessions per month (totaling up to 60 minutes per month); up to 6 months)
- Change in LMWPHI score(At baseline and at 6 months)
- Rate of adherence to medication schedule(Up to 6 months)
- Self-reported rate of adherence to lifestyle care plan(Up to 6 months)