Recruiting

Telehealth

Sponsor:

Georgetown University

Code:

NCT06315855

Conditions

Oral Mucositis

Periodontal Diseases

Cancer

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Telehealth Intervention (THI)

Study Details

Brief summary:

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.

Conditions

Oral Mucositis

Periodontal Diseases

Cancer

Study ID

NCT06315855

Start date

Aug 20, 2024

Status verified date

Jan, 2026

Completion date

Aug 25, 2027

Anticipated

Primary completion date

Aug 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • male and female cancer survivors who are either ≥ 6 months after competing primary therapy for cancer treatment (N=100)
  • between 25-75 years of age
  • all race/ethnic groups
  • own a smart phone.

Exclusion Criteria:

  • all head and neck/oral cancer survivors
  • less then 25 years and older than 75 years of age
  • recurrence/second cancers or undergoing treatment
  • unable to provide informed consent.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Telehealth Intervention (THI) arm

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.

no intervention: Usual Care (UC) arm

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.

Interventions

Telehealth Intervention (THI)

The THI is a 6-month intervention. On a monthly basis, the survivor will be queried via telehealth (zoom or smart phone) oral and health related symptoms by nurse practitioner or navigator. Based on the initial imaging and the monthly assessments, the patients will be provided with tools and instructions for oral health maintenance which may consist of mucositis management and/or diet and lifestyle counseling. All participants will be provided a Resource directory that is to be used to identify a dentist that is best suited for him/her. Post intervention, follow-up assessments will be conducted at 6-, 9- and 12-months post randomization.

Primary outcome measure

  • mucositis [ Time Frame: baseline and repeated at 6 and 12 months ]
  • gingival inflammation and periodontal disease [ Time Frame: baseline and repeated at 6 and 12 months ]
  • tooth decay [ Time Frame: baseline and repeated at 6 and 12 months ]
  • oral health related quality of life [ Time Frame: baseline and repeated at 6 and 12 months ]

Central Contacts and Locations

Locations

Georgetown Lombardi Office of Minority Health

Recruiting

Washington D.C., District of Columbia, United States, 20003

Contacts

More Information

Sponsor

Georgetown University

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2026-01-22.