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Maximizing Quality of Life After Head and Neck Cancer Through Rehabilitation

This study is for people with head and neck cancer who are receiving treatment that includes cisplatin chemotherapy, radiation, and/or surgery. These treatments can cause hearing loss and difficulty swallowing (dysphagia). This trial compares the usual swallowing therapy (Intensive Dysphagia Therapy, or IDT) to a new, more complete program called TIMELY REHAB. TIMELY REHAB includes the standard swallowing therapy along with proactive care to protect your hearing and balance. The goal is to see if TIMELY REHAB can reduce stress and improve your quality of life after cancer treatment. You may be able to join if you are 18-89 years old, have been diagnosed with head and neck cancer within the last 60 days, and are prescribed IDT. The study plans to enroll 74 participants, but its current recruitment status is unclear.

Study design
This is an interventional study where participants are randomly assigned to either the usual swallowing therapy or the TIMELY REHAB program. It plans to enroll 74 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your stress from cancer and its treatment will be measured prior to treatment, 3 months after treatment starts, and 12-18 months after treatment starts.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07622407

Maximizing Quality of Life After Cancer Through Rehabilitation

Not Yet Recruiting
NAAges 18–89InterventionalSupportive care
VA Office of Research and Development
~74 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:TIMELY REHAB

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stress from cancer and its treatment
Measured over Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment

Conditions

Head and Neck Cancer
Hearing Loss
Tinnitus
Dysphagia

Explore related trials

Malignant Head and Neck Neoplasm

Where it's being run

3 sites across 3 states
North Carolina1
Oregon1
Wisconsin1

Study leadership

  • Dawn L Konrad-Martin, PhD · PRINCIPAL_INVESTIGATOR · VA Portland Health Care System, Portland, OR

Who to contact

Dawn L Konrad-Martin, PhD
[email protected]
(503) 220-8262 · ext. 52962
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Stress from cancer and its treatmentAssessed prior to treatment, 3 months post-, and 12-18 months post-initiation of 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.