Thyroid Neoplasms
Conditions
Keywords
symptom burden, self efficacy, feasibility studies, internet-based intervention, pilot projects, neoplasms, radioactive iodine treatment, iodine radioisotopes, health-related quality of life, informational needs
Brief summary
The goal of this clinical trial is to learn if adult patients diagnosed with differentiated thyroid cancer can easily use and benefit from an online tool aimed to provide patients with educational resources and symptom management strategies to improve their quality of life after radioactive iodine (RAI) treatment. The main questions it aims to answer are: 1. Can patients easily use and benefit from the RAI Support intervention? 2. Does RAI Support improve health-related quality of life (overall well-being) compared to usual care? This research will help test better digital tools to support thyroid cancer survivors in managing their health after RAI treatment. Researchers will compare RAI Support to treatment as usual (a publicly available informational website about thyroid cancer) to see if RAI Support works to improve patients' overall well-being. Participants will: 1. Receive access to RAI Support or an informational website (treatment as usual) for four weeks. 2. Use the assigned website once a week for up to four weeks. 3. Complete two online questionnaires (an initial questionnaire and a final questionnaire after four weeks of using the assigned website) about symptoms related to RAI treatment, mood, and confidence in managing symptoms. 4. Complete an optional 60 minute virtual interview about your experiencing using the assigned website.
Interventions
BEHAVIORALRadioactive Iodine Support (RAI Support)
RAI Support consists of multimedia content (images, videos, text, audio, and infographics across different website pages) that is written at an 8th grade reading level. RAI Support uses patient materials that are visually diverse to appeal to patients from different racial and ethnic backgrounds and inclusion of all genders. RAI Support users can access short (\~3 minutes or less) clinician-approved symptom management education videos and follow clinician-led video-guided activities such as nutrition management for dry mouth. In addition, RAI Support contains infographic pages about specific symptoms of RAI (e.g., salivary, lacrimal, and nasal symptoms with strategies for symptom management) and a resources page consisting of a printable treatment summary and survivorship plan to bring to provider appointments and access to evidence-based stress-management resources such as relaxation recordings.
OTHERTreatment as Usual (TAU)
The American Cancer Society (ACS) website on Radioactive Iodine (Radioiodine)Therapy for Thyroid Cancer is the TAU comparison. This website is a reputable and trusted source of information about cancer, with relevant content and web availability. Using the ACS website allows participants in both groups to receive information (addressing ethical concerns) through a website (similar delivery mode for information).
Sponsors
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older (papillary or follicular carcinoma) * Diagnosed with differentiated thyroid cancer * Received radioactive iodine (RAI) treatment less than or equal to three years ago. * Mild to moderate symptoms of RAI * Able to provide informed consent in English * Access to a computer, tablet, or smartphone with internet connectivity
Exclusion criteria
* A condition that precludes providing informed consent or completing study procedures (cognitive or psychiatric condition, hearing problems) as identified by the patient's physician or as assessed by a trained study team member.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (Retention and Engagement) | 4 weeks | Feasibility is defined by at least 86% of patients are retained and complete the 4-week post-assessment. Feasibility is also defined as greater or equal to 70% RAI Support engagement rate (greater or equal to 3/4 website sections). |
| Acceptability (Quantitative) | 4 weeks | Acceptability will be assessed using the Acceptability of Intervention Measure (AIM). AIM is a 4-item questionnaire that assesses the acceptability of an intervention. Each item is on a 5-point Likert scale (1=Completely disagree; 5= Completely agree). Higher scores indicate greater acceptability. |
| Acceptability (Qualitative) | 4 weeks | Acceptability will also be assessed from qualitative feedback gathered from participants in the RAI Support intervention condition. Up to 20 RAI Support completers will be asked to complete an individual exit interview with the PI or a trained study team member to elicit feedback on the helpfulness of the intervention, participant burden, barriers to intervention participation, satisfaction with components of the intervention, and satisfaction with the delivery, modality, and length of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy- General-7 (FACT-G7; Health-related quality of life) | 4 weeks | The Functional Assessment of Cancer Therapy- General-7 (FACT-G7) questionnaire consists of 7 items assessing the physical, emotional, and functional well-being of adult cancer patients. Each item is on a five-point Likert scale (0= Not at all; 4= Very much). Scores range from 0-28. Higher scores are indicative of better HRQOL. |
Countries
United States
Contacts
CONTACTAlaina L Carr, PhD
CONTACTValeria Gómez, BS
PRINCIPAL_INVESTIGATORAlaina Carr, PhD
Georgetown University
Outcome results
None listed