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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-01920 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 2272021 | Other Identifier | Roswell Park Cancer Institute |
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This clinical trial compares intensive symptom evaluation with supportive care to standard symptom management in patients with head and neck cancer that has not spread to other places in the body (non-metastatic). Standard symptom management involves symptom management during and after radiation therapy, using problem-focused history and physical examination followed by appropriate symptomatic management as appropriate per treating physician's discretion. Intensive symptom management with monitoring patient reported outcomes is performed among patients with metastatic cancers receiving systemic therapies and with various cancers receiving radiation therapy. This trial may help researchers determine the impact of intensive symptom surveillance in patients with non-metastatic head and neck cancers.
PRIMARY OBJECTIVE:
I. Using study questionnaires to determine the impact of intensive symptom evaluation with supportive care as needed per treating physician's discretion versus standard symptom management on time to first acute care visits at 3 months.
SECONDARY OBJECTIVES:
I. Using study questionnaires to determine the impact of intensive symptom evaluation with supportive care as needed per treating physician's discretion versus standard symptom management on (1) changes in health-related quality of life (HRQOL), financial burden, and caregiver burden from baseline, (2) time to first acute care visits at 1 or 6 month, (3) locoregional (LRF) and distant failure (DF), and (4) progression-free (PFS) and overall survival (OS) outcomes.
II. Using study questionnaires to determine the impact of intensive symptom evaluation with supportive care as needed per treating physician's discretion versus standard symptom management when stratified.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A: Patients complete a quality of life questionnaires over 10-15 minutes twice weekly (BIW) during standard of care radiation therapy and once weekly (QW) for the first month after completing standard of care radiation therapy course, and then once monthly for 6 months.
GROUP B: Patients receive standard symptom management QW during standard of care radiation therapy for 6 months after completing radiation therapy course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (quality of life questionnaire) | Experimental | Patients complete a quality of life questionnaires over 10-15 minutes BIW during standard of care radiation therapy and QW for the first month after completing standard of care radiation therapy course, and then once monthly for 6 months. |
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| Group B (standard symptom management) | Active Comparator | Patients receive standard symptom management QW during standard of care radiation therapy and for 6 months after completing radiation therapy course. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Therapy | Other | Receive standard symptom management |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to first acute care visit | to evaluate the impact of intensive symptom evaluation compared to standard symptom management on time to first acute care visits at 3 months with time to first acute care visits. | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health-related quality of life EORTC QLQ-C30 | Patient reported outcome assessment measured data Quality of life data will be obtained via European Organisation for Research and Treatment of Cancer Quality of Life Cancer Patients (EORTC QLQ-C30). It It is a 30-item questionnaire assessing other cancer-related symptoms | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anurag K Singh | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Quality-of-Life Assessment | Other | Complete quality of life questionnaire |
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| Questionnaire Administration | Other | Complete quality of life questionnaire |
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| Change in financial burden | Change in patient reported outcomes measured using the Comprehensive Score for Financial Toxicity (COST). Financial toxicity is assessed using an 11-item patient-reported measure of financial stress used in cancer patients. The COST yields a total score with higher scores indicating less financial toxicity | Baseline to 6 months |
| Change in caregiver burden | Will be evaluated with the Caregiver Reaction Assessment (CRA). Summary score range between 5 and 120. A higher score indicates a higher level of burden. | Baseline to 6 months |
| Time to first acute care visits | Patient reported 9 item questionnaire to evaluate the impact of intensive symptom evaluation compared to standard symptom management on time to first acute care visits at 3 months with time to first acute care visits. | At 1 or 6 month |
| Locoregional failure | Analyzed with the questionnaire and standard of care tumor assessment, disease progression, and survival status information. | Time interval from diagnosis to locoregional failure, assessed up to 6 months |
| Distant failure | Analyzed with the questionnaire and standard of care tumor assessment, disease progression, and survival status information. | Time interval from diagnosis to distant failure outside head and neck region, assessed up to 6 months |
| Progression free survival | Analyzed with the questionnaire and standard of care tumor assessment, disease progression, and survival status information. | Time interval from diagnosis to tumor recurrence or progression of disease, assessed up to 6 months |
| Overall survival | Analyzed with the questionnaire and standard of care tumor assessment, disease progression, and survival status information. | Time interval from diagnosis to death from any cause, assessed up to 6 months |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| D000070659 | Patient Comfort |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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