Not yet taking people in United StatesNo phase

Rehabilitation program for veterans with head and neck cancer

Tests a broader rehabilitation program with swallowing therapy in veterans with head and neck cancer.

Key facts

Who runs it: VA Office of Research and Development
Where: Durham, Madison, and Portland, United StatesSee the 3 sites
Trial code: NCT07622407
Registry title: Maximizing Quality of Life After Cancer Through Rehabilitation
Status: Not yet recruiting
People taking part: 74 people, planned
Starts: 1 Mar 2027
Expected to end: 30 Jun 2030
Type of study: Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested: TIMELY REHAB
Record updated: 3 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults newly diagnosed with head and neck cancer who are getting treatment and swallowing therapy. It tests added hearing, balance and rehabilitation care.

Age: 18 to 89 years
Sex: All sexes can join.
Disease stage: Head and neck cancer diagnosed within the past 60 days, with no spread to distant parts of the body at enrollment.
Earlier treatment: The treatment plan must include at least 1 dose of cisplatin-based chemotherapy, or at least one dose of radiotherapy and/or surgery. Intensive Dysphagia Therapy must be prescribed. No prior or planned total laryngectomy or cochlear implant.

Main reasons for not taking part

Moderate or severe swallowing problems at enrollment (DIGEST grade >=2)
Severe or profound hearing loss at enrollment
Meniere's disease, a retrocochlear disorder, or an active or recent middle ear disorder
Second primary cancer in the thorax or central nervous system, or distant spread
Not able to take part because of thinking or physical problems, or no legal ability to consent

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

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

Who cannot take part

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
diagnosis of second primary non-head and neck cancer in the thorax or the central nervous system at enrollment
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)
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
Participants will be excluded is they have:
distant metastasis at enrollment
moderate/severe dysphagia at enrollment per baseline videofluoroscopy DIGEST grade >=2
severe/profound hearing loss at enrollment per baseline audiogram
unwilling to participate

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 89 years old?

Where in United States

Durham VA Medical Center, Durham, NCDurham, United StatesContact: Candice Quinn, PhDNot yet recruiting
William S. Middleton Memorial Veterans Hospital, Madison, WIMadison, United StatesContact: Nicole Rogus-Pulia, PhDNot yet recruiting
VA Portland Health Care System, Portland, ORPortland, United StatesContact: Danielle N Beaudry, MANot yet recruiting

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

1. the standard swallowing therapy, 2. proactive management to protect hearing and balance or manage problems that can't be prevented, and 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.

The tele-oncology nurse checks for other rehabilitation needs using a screening tool validated in Veterans, shares this information with the team, and advises patients about recommended care.

The investigators expect the results to show that managing hearing loss with swallowing therapy while improving care coordination for rehabilitation reduces survivors' stress and improves well-being compared to swallowing therapy alone.

The 2 groups in the trial

TIMELY REHABTreatment being tested
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.
Usual CareNo study treatment, for comparison
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.