Clinical trial · Interventional
A Study Comparing Geriatric Co-Management With Geriatric Guided Supportive Care in Older Patients Receiving Chemoradiation Therapy for Their Head and Neck Cancer
Pilot Randomized Clinical Trial of Geriatric Comanagement or Geriatric Guided Supportive Care for Older Patients With Head and Neck Cancer Receiving Radiation and Chemotherapy
NCT05239000CI-TRIAL-00100420completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The researchers are doing this study to see whether geriatric co-management or geriatric guided supportive care are good approaches for managing side effects in older patients who have head and neck cancer and are receiving chemoradiation therapy. This study will provide valuable information about different ways to manage side effects in older patients receiving chemoradiation therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| geriatric co-management | Other | — | UNRESOLVED |
| geriatric guided supportive care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- geriatric co-management
- description
- Geriatric co-management involves a consultation with a geriatrician prior to initiating head and neck radiation and chemotherapy. Consultation with geriatricians can occur in-person or remotely via telemedicine. During this visit, the geriatrician will review the results of the eRFA and create a plan to manage geriatric deficits. Geriatric co-management involves optimization of comorbid conditions, management of polypharmacy, and supportive care referrals to address geriatric deficits. Geriatricians also work in conjunction with the treating oncologists to ensure patients have appropriate pain management and bowel regimens. Additional follow up visits after the initial consultation are at the discretion of the geriatrician may vary between patients depending on the clinical need.
- interventionNames
- Other: geriatric co-management
- type
- EXPERIMENTAL
- label
- geriatric guided supportive care
- description
- Geriatric guided supportive care will be carried out by oncologists. After the patient completes the eRFA, an automated report is generated that identifies the patient's geriatric deficits. The automated report also includes suggested interventions for each deficit (e.g, referral to physical therapy. For instance, automated suggestions for a patient with a history of falls include consultation with physical therapy, neurologic evaluation, a home safety evaluation, or use of supportive devices. Automated recommendations for patient with high level of distress or depression include referral to psychiatry or social work, involvement in a cancer support group, or additional time spent addressing questions and fears. The oncology team will review the automated report from the eRFA and create an intervention plan prior to initiation of head and neck radiation and chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 65 * Pathologically (histologically or cytologically) diagnosis of head and neck cancer of oral cavity, oropharynx, larynx, or hypopharynx * Patient will receive a 6 to 7 week course of intensity modulated radiation therapy and concurrent chemotherapy either in definitive or post-operative setting * Able to read and understand English * Able to provide informed consent Exclusion Criteria: * Patients who have previously consulted with or are followed by a geriatrician * Inability to use telemedicine if unable to present to clinic visits in person * Inability to complete the eRFA (patient is unable to comprehend or answer questions included on the eRFA) * Treatment with proton therapy * Patients on therapeutic clinical trials of experimental therapies or those not receiving standard of care
References
Publications (0)
Data not yet available
No reference posted for this study.