Telehealth for Oral Health in Cancer Survivors

Overseen By Smith

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgetown University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 6 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will conduct a 2-arm 6-month randomized clinical controlled trial to evaluate the effectiveness of an oral Telehealth Intervention (THI) in preventing cancer-related oral complications, improving oral health maintenance and oral health related quality of life, and reducing systemic inflammation compared to Usual Care (UC) among unselected cancer survivors.

Eligibility Criteria

This trial is for cancer survivors aged 25-75, from any racial or ethnic group, who have completed their primary cancer therapy at least 6 months ago. Participants must own a smartphone to be eligible.

Inclusion Criteria

All race/ethnic groups

Own a smart phone

I finished my main cancer treatment over 6 months ago.

Exclusion Criteria

I am between 25 and 75 years old.

I am a survivor of head and neck or oral cancer.

I have had cancer more than once or am currently being treated for another cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Intraoral imaging and collection of baseline saliva and blood samples

1 week

1 visit (in-person)

Treatment

Participants engage in a 6-month Telehealth Intervention (THI) or receive Usual Care (UC)

6 months

6 virtual sessions (THI arm), biweekly text messages (both arms)

Follow-up

Participants are monitored for oral and systemic health outcomes post-intervention

6 months

2 visits (in-person) at 6 and 12 months

Treatment Details

Interventions

• Telehealth Intervention (THI)

Trial Overview The study tests an oral Telehealth Intervention (THI) against Usual Care (UC) over six months. It aims to prevent oral complications, improve mouth health and quality of life, and reduce inflammation in unselected cancer survivors.

Participant Groups

Group I: Telehealth Intervention (THI) arm Experimental Treatment 1 Intervention

The THI is a 6-month intervention. Participants randomized to THI arm will engage in 6,1-hour virtual sessions with trained study personnel. Modules contain a 1) participant check-in, 2) content designed to build oral health literacy and self-efficacy, 3) and goal-setting. Coaches will use a facilitation guide, layered with motivational interviewing to conduct telehealth sessions. Participants will also receive biweekly text messages aligned with module content. Post-intervention follow-up will occur at 6- and 12-month post-randomization.

Group II: Usual Care (UC) arm Active Control 1 Intervention

This group will receive biweekly text messages on general health behaviors as a retention strategy. This arm will receive no other outside interventions. The Dental Resource directory will be provided to all participants.

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+