Maximizing Quality of Life After Cancer Through Rehabilitation

ClinicalTrials.gov ID

NCT07622407

Lead Sponsor

VA Office of Research and DevelopmentFED

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

74Estimated

Last Update Posted

Jun 3, 2026Actual

Start Date

Mar 1, 2027Estimated

Primary Completion Date

Mar 31, 2030Estimated

Completion Date

Jun 30, 2030Estimated

Official Title

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

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. 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.

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.

• Head and Neck Cancer
• Hearing Loss
• Tinnitus
• Dysphagia

• TIMELY REHAB

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

VA Office of Research and DevelopmentFED

Collaborators

William S. Middleton Memorial Veterans HospitalFED

Durham VA Health Care SystemFED

danielle.beaudry@va.gov503-220-8262 ext. 57524

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