NCT07622407Toborzás még nem indult
Maximizing Quality of Life After Cancer Through Rehabilitation
A Transdisciplinary Interventions to MaximizE QuaLitY of Life After Cancer Through REHABilitation (TIMELY REHAB)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 3.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 74 (tervezett)
- Első benyújtás
- 2026. máj. 18.
- Kezdés
- 2027. márc. 1.
- Elsődleges befejezés
- 2030. márc. 31.
- Fő szponzor
- VA Office of Research and Development
- Betegségek
- Fej-nyaki daganatok
- NCT-szám
- NCT07622407
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 74
- 2027. márc. 1. és az elsődleges befejezés (2030. márc. 31.) között
- 3 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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;
Más betegség
- diagnosis of second primary non-head and neck cancer in the thorax or the central nervous system at enrollment;
- 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);
- 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;
Egyéb
- Participants will be excluded is they have:
- distant metastasis at enrollment;
- moderate/severe dysphagia at enrollment per baseline videofluoroscopy DIGEST grade >=2;
- severe/profound hearing loss at enrollment per baseline audiogram;
- unwilling to participate.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 89 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | Egyesült Államok | Ismeretlen állapot |
| William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Egyesült Államok | Ismeretlen állapot |
| VA Portland Health Care System, Portland, OR | Portland | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.