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| ID | Type | Description | Link |
|---|---|---|---|
| BeWell360 | Other Identifier | Mayo Clinic |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (HWC) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling | Other | Attend HWC sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Assessed by the number enrolled out of the number of eligible participants approached | Up to 1 year |
| Retention rate | Assessed by the number of participants who complete follow-up sessions | At 6 months |
| Session completion rates | Assessed by the number of sessions attended (out of 6). Success is defined as attendance at ≥ 4 of 6 sessions attended. | Up to 6 months |
| Study completion rate | Assessed by the number of participants who complete study compared to the number of participants lost to-follow-up. | At baseline and at 6 months |
| Intervention fidelity | Assessed by the number of sessions that meet ≥ 80% of checklist-defined core elements | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months |
| Self-reported rate of adherence to lifestyle care plan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu | |
| Megan Warner | Contact | 904-953-0476 |
| Name | Affiliation | Role |
|---|---|---|
| Abd Moain Abu Dabrh, MB, BCh, MS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Interview | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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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). |
| Up to 6 months |
| 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 | At baseline and at 6 months |
| ID | Term |
|---|---|
| D018263 | Adenocarcinoma, Follicular |
| D000077273 | Thyroid Cancer, Papillary |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000231 | Adenocarcinoma, Papillary |
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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