Health and Wellness Coaching to Improve Adherence to Healthy Habits and Treatment Plans in Papillary and Follicular Thyroid Cancer Survivors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Counseling

    Other intervention

    Attend HWC sessions

  • Interview

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Supportive care (HWC)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Recruitment rate

Assessed by the number enrolled out of the number of eligible participants approached

Time frame
Up to 1 year
2

Retention rate

Assessed by the number of participants who complete follow-up sessions

Time frame
At 6 months
3

Session completion rates

Assessed by the number of sessions attended (out of 6). Success is defined as attendance at ≥ 4 of 6 sessions attended.

Time frame
Up to 6 months
4

Study completion rate

Assessed by the number of participants who complete study compared to the number of participants lost to-follow-up.

Time frame
At baseline and at 6 months

Secondary outcomes

1

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.

Time frame
Up to 6 months
2

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).

Time frame
Up to 6 months
3

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

Time frame
At baseline and at 6 months

Other outcomes

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