Maximizing Quality of Life After Cancer Through Rehabilitation (TIMELY REHAB)

A Transdisciplinary Interventions to MaximizE QuaLitY of Life After Cancer Through REHABilitation (TIMELY REHAB)

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. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Cancer; Dysphagia; Hearing Loss; Tinnitus
• Intervention / Treatment: Other: TIMELY REHAB

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dawn L Konrad-Martin, PhD; Phone Number: 52962 (503) 220-8262; Email: Dawn.Martin@va.gov
• Study Contact Backup: Name: Michelle E Hungerford, AuD; Phone Number: (503) 721-1089; Email: michelle.hungerford@va.gov

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Durham VA Medical Center, Durham, NC
      • Contact: Candice Quinn, PhD; Phone Number: 919-286-0411; Email: candice.quinn@va.gov
  • Oregon
    • Portland, Oregon, United States, 97207-2964
      • VA Portland Health Care System, Portland, OR
      • Contact: Danielle N Beaudry, MA; Phone Number: 57524 503-220-8262; Email: danielle.beaudry@va.gov
      • Principal Investigator: Dawn L Konrad-Martin, PhD
  • Wisconsin
    • Madison, Wisconsin, United States, 53705-2254
      • William S. Middleton Memorial Veterans Hospital, Madison, WI
      • Contact: Nicole Rogus-Pulia, PhD; Phone Number: 708-699-8615; Email: npulia@wisc.edu
      • Contact: Joanne Yee, MS; Phone Number: 6082807000; Email: Joanne.Yee@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIMELY REHAB; 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 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.
No Intervention: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Management of dysphagia	Measurements will include psychosocial changes secondary to swallowing function (MD Anderson Dysphagia Inventory).	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.	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.	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.	Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Assessed within one month prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Durham VA Health Care System; William S. Middleton Memorial Veterans Hospital
• Investigators: Principal Investigator: Dawn L Konrad-Martin, PhD, VA Portland Health Care System, Portland, OR

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Dysphagia; Cisplatin; Chemotherapy; Tinnitus; Ototoxicity; Sensorineural hearing loss; Audiology; Drug-related side effects and adverse reactions; Professional practice gaps
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Chemically-Induced Disorders; Esophageal Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Radiation Injuries; Pharyngeal Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Ototoxicity; Head and Neck Neoplasms; Deglutition Disorders; Drug-Related Side Effects and Adverse Reactions; Hearing Loss; Hearing Loss, Sensorineural; Tinnitus
• Other Study ID Numbers: RRD3-011-25M; I01RD000548-01A1 (Other Grant/Funding Number: VA RRDT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that can be completely deidentified and are included in results of any publications from this project.
• IPD Sharing Time Frame: Following approval of a VA data use agreement.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No