NCT07622407

Brief Summary

Treatment for head and neck cancer (HNC) often includes cisplatin chemotherapy and radiation. This treatment causes hearing loss and trouble swallowing in 70% of patients. If untreated, these symptoms increase stress and lower quality of life for survivors. Veterans with HNC usually get help for swallowing. However, damage to the hearing and balance systems-known as ototoxicity-is often missed or only addressed when it becomes very severe. To fill this gap, the investigators plan a clinical trial at two VA sites. The investigators compare the usual swallowing therapy alone to a new, more comprehensive program. This new program includes:

  1. 1.the standard swallowing therapy,
  2. 2.proactive management to protect hearing and balance or manage problems that can't be prevented, and
  3. 3.other rehabilitation services based on a tele-oncology nurse's assessment. The hearing and balance intervention features quick screening tests and validated questionnaires to identify early signs of damage. These are given during cancer or radiation treatment visits to maximize convenience for the patient. Audiologists review these results remotely using tele-health technology. The investigators will also use new tools to predict and spot hearing problems that are personalized for each patient. The audiologist works closely with the patient and the care team to arrange further help if needed.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
41mo left

Started Mar 2027

Typical duration for not_applicable head-and-neck-cancer

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2027

Expected
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

3.1 years

First QC Date

May 18, 2026

Last Update Submit

May 27, 2026

Conditions

Hearing LossTinnitusDysphagiaHead and Neck Cancer

Keywords

AudiologyChemotherapyCisplatinDrug-related side effects and adverse reactionsHead and Neck CancerOtotoxicityDysphagiaProfessional practice gapsSensorineural hearing lossTinnitus

Outcome Measures

Primary Outcomes (1)

  • Stress from cancer and its treatment

    This will be measured with the Impact of Event Scale-Revised (IES-R.) This is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events. Items correspond directly to 14 of the 17 DSM-IV symptoms of PTSD. Respondents are asked to identify a specific stressful life event (in this case, cancer diagnosis and care) and then indicate how much they were distressed or bothered during the past seven days by each "difficulty" listed.

    Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment

Secondary Outcomes (4)

  • Management of dysphagia

    Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment

  • Perceived impairment of hearing loss

    Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment

  • Psychosocial impacts of hearing loss

    Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment

  • Psychosocial impacts of tinnitus

    Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment

Other Outcomes (2)

  • Uptake of audiology services

    Assessed within one month prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment

  • Positive VA CaRe screen result rate indicating need for new referral

    Assessed within one month prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment

Study Arms (2)

TIMELY REHAB

EXPERIMENTAL

Participants will undergo regular standard of care for swallowing with increased access to hearing and other rehabilitative services through a proactive screening and referral program.

Other: TIMELY REHAB

Usual Care

NO INTERVENTION

Participants will undergo regular standard of care for swallowing. In this arm, hearing and other rehabilitation care is reactive in response to a problem noticed by the patient and their care team.

Interventions

TIMELY REHABOTHER

Participants randomized to the TIMELY REHAB arm receive a coordinated cancer rehabilitation program that includes: Intensive Dysphagia Therapy (IDT): Participants receive the VA's standard-of-care swallowing therapy for patients with head and neck cancer. Ototoxicity Management: This comprehensive program provides ototoxicity screening and referral services to support auditory and balance health. It incorporates patent-pending, patient-specific ototoxicity forecasting and identification models alongside chairside high-frequency audiometry, delivered using store-and-forward tele-audiology. Screening for Other Rehabilitation Needs: Additional assessments are conducted to address a range of rehabilitation concerns, such as pain, mental health, and mobility. These are delivered via telehealth visits by an advanced practice oncology nurse using the VA-validated Cancer Rehabilitation (CaRe) Screen, supporting a holistic intervention consistent with the VA's Whole Health model.

TIMELY REHAB

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be:
  • diagnosed with head and neck malignancy within the past 60 days;
  • prescribed a treatment plan at participating site that includes at least 1 dose of a cisplatin-based chemotherapy, or at least one dose of radiotherapy and/or surgery;
  • prescribed Intensive Dysphagia Therapy (IDT) at the participating site;
  • sufficient fluency in written English to be able to complete the study patient reported outcome questionnaires.

You may not qualify if:

  • Participants will be excluded is they have:
  • distant metastasis at enrollment;
  • diagnosis of second primary non-head and neck cancer in the thorax or the central nervous system at enrollment;
  • prior or planned total laryngectomy;
  • prior or planned cochlear implant;
  • head and neck radiotherapy for thyroid or cutaneous/skin primary tumors, regardless of neck fields;
  • cognitively or physically unable to participate (patient, physician or nurse report patient is incapable of participating), medical records indicate that participant exhibits aggressive behavior, participant has documented dementia, Alzheimer's disease, or severe psychosocial disorder, or notes indicate an individual is not legally capable of providing informed consent (participant has a legal guardian);
  • moderate/severe dysphagia at enrollment per baseline videofluoroscopy DIGEST grade \>=2;
  • severe/profound hearing loss at enrollment per baseline audiogram;
  • exhibits Meniere's disease or retrocochlear disorder based on baseline hearing test results, patient report or notes in electronic medical records;
  • exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, baseline hearing test results, patient report, or medical record documentation;
  • unwilling to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

Location

Related Publications (1)

  • Yee J, Pulia M, Knobloch MJ, Martinez R, Daggett S, Smith B, Musson N, Rogus-Pulia N. Implementation of the VA Intensive Dysphagia Treatment Program: A Mixed-Methods Evaluation. Health Serv Insights. 2022 Sep 2;15:11786329221121207. doi: 10.1177/11786329221121207. eCollection 2022.

    PMID: 36081831BACKGROUND

MeSH Terms

Conditions

Head and Neck NeoplasmsHearing LossTinnitusDeglutition DisordersDrug-Related Side Effects and Adverse ReactionsOtotoxicityHearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesChemically-Induced DisordersPathologic ProcessesRadiation InjuriesWounds and Injuries

Study Officials

  • Dawn L Konrad-Martin, PhD

    VA Portland Health Care System, Portland, OR

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn L Konrad-Martin, PhD

CONTACT

(503) 220-8262Dawn.Martin@va.gov

Michelle E Hungerford, AuD

CONTACT

(503) 721-1089michelle.hungerford@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study staff responsible for analyzing research data will be blinded to the study arms.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: In this prospective study, patients will go through enrollment and screening for eligibility before being randomly assigned to one of two study groups. Randomization will use a block sequential system, meaning that groups of 4 and 6 patients will be arranged in a random order to make sure that the TIMELY REHAB and usual care arms stay balanced during the study. Each study site will have its own randomization schedule to maintain balance between the treatment arms at each location. If there are any mistakes in randomization, the study statistician will be consulted to decide the best next steps. All patients in both groups will receive proactive care for swallowing difficulties (intensive dysphagia therapy). Patients in the TIMELY REHAB arm will also receive proactive hearing and balance care (ototoxicity management) co-located with their chemotherapy or radiation treatment, as well as screening for other rehabilitation needs at three specific points during oncology treatment.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

June 3, 2026

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

June 30, 2030

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

IPD that can be completely deidentified and are included in results of any publications from this project.

Shared Documents
STUDY PROTOCOL
Time Frame
Following approval of a VA data use agreement.
Access Criteria
The corresponding author of the publication should be contacted. The requestors will be required to sign a data use agreement that will outline the data requested and method for dispersion. This DUA must be approved by local VA leadership prior to any data exchange and all data will be fully de-identified.

Locations

US(3)