An interventional study of TIMELY REHAB in Head and Neck Cancer, Hearing Loss and Tinnitus, sponsored by VA Office of Research and Development. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Supportive care
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:
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.
Head and neck cancer (HNC) affects Veterans at three times the rate of the general population and is now the fourth most common cancer diagnosed annually in VA facilities. Treatment for HNC typically includes cisplatin chemotherapy plus radiation, with or without surgery. Radiation causes dysphagia in 70% of patients, and cisplatin chemotherapy causes hearing loss at the same rate. These side effects are significant independent predictors of elevated stress and reduced quality of life (QoL) in cancer survivors. However, although Veterans with HNC get ongoing, proactive, intensive dysphagia therapy for swallowing, damage to the hearing and balance systems-known as ototoxicity-is often missed or addressed after becoming severe. This care gap represents a missed opportunity to optimize the long-term function and QoL of Veterans with HNC through timely rehabilitation. Unfortunately, Veterans with HNC face difficulties accessing supportive care that could optimize their post-treatment function.
The VA's Intensive Dysphagia Treatment (IDT) program is transforming care for Veterans with HNC by integrating speech pathology with oncology and using telehealth to improve access and adherence to dysphagia interventions, leading to better outcomes. However, audiology services, which are comanaged with speech pathology in VA, and other rehabilitation services, remain disconnected from IDT and are severely underutilized.
Auditory and vestibular deficits are the third most prevalent service-connected disabilities by body system, affecting over 4.6 million Veterans in FY2024. Spending on hearing aids reached $466.4 million in FY2024. The VA and DoD recently collaborated on a $2.1 million investment for a Tinnitus Clinical Practice Guideline. These efforts indicate the VA's readiness for a coordinated cancer rehabilitation approach that includes routine ototoxicity management.
This project's usual care arm is the standard IDT intervention. The intervention arm, called TIMELY REHAB, will expand the VA's IDT program by integrating proactive ototoxicity management, as well as visits by a tele-oncology nurse utilizing the VA-validated Cancer Rehabilitation (VA CaRe) Screen to assess the need for additional rehabilitation for potential problems such as pain, mental health, and mobility. Novel and impactful aspects include: (a) ototoxicity screening in oncology units enhanced through store and forward data sharing with tele-audiologists; (b) patient-specific audiogram prediction models for forecasting ototoxicity risk prior to treatment, and detecting significant hearing changes during treatment; (c) electronic case management to support initiating patient-tailored rehabilitation within 14 days of positive screen to mitigate impacts; and (d) a series of tele-oncology visits by an advanced practice nurse who checks for any unmet prehabilitation- or rehabilitation- needs using a screening tool validated in Veterans, advises the patient about recommended care, and shares the information discussed with the care team. Rehabilitative care in the TIMELY REHAB arm is fully integrated within the oncology care pathway, leveraging the existing IDT implementation framework. This includes using IDT's patient identification and oncology treatment tracking systems and expanding upon its online clinician training and consultation platform with standardized training modules. This approach is expected to provide better continuity of care and access to VA rehabilitation services than the usual care approach.
This project intends to reduce barriers to quality cancer rehabilitation for Veterans with HNC by leveraging existing Audiology and Speech Pathology Service efficiencies in identifying, scheduling, tracking, and referring patients. Project aims for the clinical trial portion of this research are: (Aim 1) Compare the benefit of TIMELY REHAB versus the standard VA IDT program using a randomized controlled trial in HNC patients; and (Aim 2) Determine the moderating effects of patient characteristics and cancer treatment on the ability of the proactive hearing and speech interventions to improve patients' stress-, ototoxicity-, and dysphagia-related functional outcomes. To accelerate translation of this research into clinical practice, this study is a Hybrid Type 1 comparative efficacy trial; as such information will be obtained in a third aim to assess the barriers and facilitators for implementing TIMELY REHAB. Aim 3 is outside the scope of clinicaltrials.gov and therefore not described herein.
Methodology: The clinical trial portion of this research is designed as a randomized comparative efficacy trial that will be conducted at two VA sites. Linear modeling will be used to assess the ability of TIMELY REHAB to reduce cancer-specific stress and optimize auditory function, while not adversely impacting swallow-related function as assessed using validated questionnaires. Generalized linear mixed models provide a natural, unified framework for contrasting treatment arms across the primary and secondary outcome measures over time. This approach allows us to model correlation within subjects over time. Each model will include the treatment group, chemo/radiation strata, and time point (baseline, 3 months) as main effects. Each model will include patient-level random intercepts. The investigators will test for random patient by time-point interactions to allow for variability in the cancer treatment effects over time across patients. This modelling approach will provide an estimate, for example, of the average IES-R score at each measurement point, treatment arm, and strata. These results permit direct contrasts between treatment arms at each time point and strata to evaluate the efficacy of the audiology component in improving cancer care outcomes for this patient population.
The investigators expect to find that rehabilitation services will be conducted less frequently for Usual Care (Arm 2) because screening for referrals beyond speech pathology services is not the focus of the Usual Care visits and Veterans with HNC may not access rehabilitation without the added support from the TIMELY REHAB (Arm 1) oncology nurse. For these reasons, the investigators hypothesize for Aim 1, that the TIMELY REHAB will minimize stress from pre-existing and cancer-treatment-related functional deficits, will optimize outcomes related to auditory function, and will not negatively impact swallowing function as compared to Usual Care.
The Aim 2 goal is to develop multivariate statistical models of the primary and secondary outcomes tested in Aim 1, to identify baseline patient characteristics that moderate treatment efficacy in this patient population. To accomplish this goal, the investigators will expand, for example, the linear model of the IES-R developed in Aim 1 to include other risk factors (baseline swallow or audiometric measures, number of comorbid conditions, and age), and their interaction with treatment arm in each model. The investigators will add an additional longitudinal time point (12-18 months) to establish the longitudinal trajectory of swallowing and hearing-related dysfunctions in patients and to investigate patient-level variability in receptiveness to intervention. The investigators treat this aim as an exploratory/pilot aim given that there has never been any formal research into this new therapeutic option for HNC patients.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 74 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must be:
Exclusion Criteria:
Participants will be excluded is they have:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment
Management of dysphagia
Measurements will include psychosocial changes secondary to swallowing function (MD Anderson Dysphagia Inventory).
Time frame: Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment
Perceived impairment of hearing loss
The Abbreviated Profile of Hearing Aid Benefit \& Hearing Handicap Inventory for Adults (APHAB) is a self-report questionnaire that can be used to assess the frequency of hearing problems in various listening situations. It includes 4 subscales: ease of communication, reverberation, background noise, and aversiveness to sounds. Global scores are calculated as the average of the EC, BN, and RV subscale scores. Higher scores reflect a greater frequency of perceived hearing difficulties.
Time frame: Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment
Psychosocial impacts of hearing loss
The Revised Hearing Handicap Inventory (RHHI) is a self-report questionnaire designed to measure the psychosocial impact of hearing loss on a patient's life. The RHHI assesses how hearing problems affect: social interactions, emotional well-being, daily activities, and quality of life. The total score is the sum of all 18 items, and a score \>6 is suggestive of a hearing-related psychosocial problem.
Time frame: Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment
Psychosocial impacts of tinnitus
The Tinnitus Primary Function Questionnaire (TPFQ) focuses on activities impacted by tinnitus, including: thoughts and emotions, hearing, sleep, and concentration. There are 12 items and each is rated on a 0-100 scale. The global score is a sum of all 12 items and higher scores indicate more perceived impairment from tinnitus.
Time frame: Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment
Uptake of audiology services
Audiology service use will be assessed using the electronic medical record to calculate the number of diagnostic audiology visits, hearing aid assessments, fitting of new hearing aids, hearing technology adjustments, falls assessments, and visits for hearing or balance rehabilitation at each testing location. The rate of audiological service visits will be used to indicate the uptake of services with a higher rate indicating better uptake.
Time frame: 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
Data from the electronic medical record will be used to tally the number and proportion of screened visits with ≥1 "yes" response, the number of "yes" responses per screening item, as well as the proportion of positive screens that resulted in a completed rehabilitation visit or an associated physiatrist consult, within 14 days.
Time frame: Assessed within one month prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment
Plan to share: Yes — IPD that can be completely deidentified and are included in results of any publications from this project.
Supporting information: 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.
Start is estimated for Mar 2027; primary completion for Mar 2030, 36 months later.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 36 months is close to that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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