Maximizing Quality of Life After Cancer Through Rehabilitation (NCT07622407) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Maximizing Quality of Life After Cancer Through Rehabilitation
United States74 participantsStarted 2027-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ba…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stress from cancer and its treatment
Timeframe: Assessed prior to treatment, 3 months post-, and 12-18 months post-initiation of treatment