Health and Wellness Coaching to Improve Patient Activation and Adherence to Healthy Habits in Differentiated Thyroid Cancer Care: A Mixed-Methods Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Medullary or anaplastic thyroid carcinoma
- •Current systemic therapy for thyroid or other cancers
- •Cognitive or psychiatric impairment precluding participation
- •Inability to complete study procedures
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Recruitment rate
时间窗: Up to 1 year
Assessed by the number enrolled out of the number of eligible participants approached
Retention rate
时间窗: At 6 months
Assessed by the number of participants who complete follow-up sessions
Session completion rates
时间窗: 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
时间窗: 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
时间窗: Up to 6 months
Assessed by the number of sessions that meet ≥ 80% of checklist-defined core elements
次要结局
- 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)