Thyroid Gland Follicular CarcinomaNCT07545837
Health and Wellness Coaching to Improve Adherence to Healthy Habits and Treatment Plans in Papillary and Follicular Thyroid Cancer Survivors
A study testing Counseling, Interview and Questionnaire Administration in people with Thyroid Gland Follicular Carcinoma and Thyroid Gland Papillary Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Gland Follicular Carcinoma, Thyroid Gland Papillary Carcinoma
- What is being tested?
- Counseling, Interview and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Megan Warner contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Megan Warner, 904-953-0476
About this study
Official title: Health and Wellness Coaching to Improve Patient Activation and Adherence to Healthy Habits in Differentiated Thyroid Cancer Care: A Mixed-Methods Pilot Study
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.
- Being tested
- Counseling, Interview, Questionnaire Administration
- Medical subject headings
- Adenocarcinoma, Follicular, Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingOther
Also called Counseling Intervention
Attend HWC sessions
InterviewOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Counseling; Other: Interview; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Assessed by the number enrolled out of the number of eligible participants approached
Measured: Up to 1 year
Retention rate
Assessed by the number of participants who complete follow-up sessions
Measured: 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.
Measured: 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.
Measured: At baseline and at 6 months
Intervention fidelity
Assessed by the number of sessions that meet ≥ 80% of checklist-defined core elements
Measured: Up to 6 months
Secondary outcomes (3)
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.
Measured: Up to 6 months
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).
Measured: 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
Measured: At baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start23 Jun 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Gland Follicular CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abd Moain Abu Dabrh, MB, BCh, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545837
- Sponsor's protocol ID
- 25-011068
- Other IDs
- BeWell360
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Wellness Coaching to Improve Patient Activation and Adherence to Healthy Habits in Differentiated Thyroid Cancer Care: A Mixed-Methods Pilot Study
- ClinicalTrials.gov ID
- NCT07545837
- Acronym / sponsor ID
- 25-011068
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (HWC) | Experimental | Other: Counseling, Other: Interview, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Medullary or anaplastic thyroid carcinoma
- Current systemic therapy for thyroid or other cancers
- Cognitive or psychiatric impairment precluding participation
- Inability to complete study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingAlso: Counseling InterventionAttend HWC sessions | Other | Supportive care (HWC) |
| InterviewAncillary studies | Other | Supportive care (HWC) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (HWC) |
Primary outcome
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
3 secondary outcomes
Rate of adherence to medication schedule
Time frame: Up to 6 months
Self-reported rate of adherence to lifestyle care plan
Time frame: Up to 6 months
Change in LMWPHI score
Time frame: At baseline and at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Warner contact
Abd Moain Abu Dabrh, MB, BCh, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling, Interview and Questionnaire Administration in people with Thyroid Gland Follicular Carcinoma and Thyroid Gland Papillary Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Up to 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.