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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-07662 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 22617 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial compares the effect of geriatric assessment (GA)-based management of supportive care to usual care in treating older patients undergoing chemotherapy and radiation therapy for head and neck cancer and their family caregivers (FCG). At least one quarter of head and neck cancers patients are diagnosed at age 70 or older. Treatment for head and neck cancers usually include surgery, chemotherapy, and radiation. Older adults are often at higher risk for functional problems, and may experience more side effects. In addition, there may be a lack of support mechanisms in place to address the needs of these older patients. Cancer not only affects the patients but the entire family, especially the family member who is the caregiver. Currently, all patients over 65 receive the same standard of care based on national guidelines, which include supportive care referrals. However, data suggests, that many patients may need more frequent and structured support. The Practical Geriatric Assessment (PGA) is a complete examination including evaluation of the physical and mental function as well as the emotional state of the older patient. PGA-based supportive care interventions may be safe, tolerable, and/or effective in managing treatment-related side effects and improving quality of life compared to usual care in older patients undergoing chemotherapy and radiation therapy for head and neck cancer and their FCG.
PRIMARY OBJECTIVE:
I. To evaluate the safety of the intervention by evaluation of treatment-related toxicities.
SECONDARY OBJECTIVES:
I. To assess the feasibility, retention, and acceptability of the intervention. II. To assess the rate of any grade non-hematologic treatment-related toxicities.
III. To assess patient/FCG self-reported outcomes. IV. To assess the symptom-related outcomes by evaluation of unplanned readmissions and emergency room (ER)/urgent care visits.
OUTLINE: Patients are randomized to 1 of 2 arms. Caregivers are randomized to the same arm as the corresponding patients.
ARM A (GA-DRIVEN INTERVENTION): Patients undergo PGA at baseline, at 4 weeks and at 1 month after completing treatment. Assessment results shared with treating oncologists and patients receive referrals to supportive care services for the problems identified with the assessment throughout the study. Caregivers may receive referrals to resources and programs.
ARM B (USUAL CARE): Patients attend regular clinical visits for treatment and follow up and receive usual care provided by their radiation oncology and medical oncology teams and referrals to supportive care services as needed throughout the study.
After completion of study interventions, patients are followed up at 1 and 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (GA-driven intervention) | Experimental | Patients undergo PGA at baseline, at 4 weeks and at 1 month after completing treatment. Assessment results shared with treating oncologists and patients receive referrals to supportive care services for the problems identified with the assessment throughout the study. Caregivers may receive referrals to resources and programs. |
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| Arm B (usual care) | Active Comparator | Patients attend regular clinical visits for treatment and follow up and receive usual care provided by their radiation oncology and medical oncology teams and referrals to supportive care services as needed throughout the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of grade 2-5 non-hematologic treatment-related toxicities | Will be assessed in patients using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be summarized using descriptive statistics. For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided. For categorical variables, counts and percentages will be provided. Observed toxicities will be summarized by type, severity, and attribution. Rates will be estimated along with the 95% exact binomial confidence interval. | Up to 3 months after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eligible participants who enroll in the study | The denominator will be all patients who meet eligibility criteria and are approached for consent. The numerator will be those who provide consent and are successfully randomized. The feasibility threshold will be met if ≥ 60% of eligible patients enroll and are randomized. Will be summarized using descriptive statistics. Rates will be estimated along with the 95% exact binomial confidence interval. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arya Amini | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Health Communication | Behavioral | Shared with treating oncology |
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| Interview | Other | Ancillary studies |
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| Office Visit | Other | Attend regular clinical visits |
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| Practical Geriatric Assessment | Other | Undergo PGA |
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| Questionnaire Administration | Other | Ancillary studies |
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| Referral | Other | Receive referrals to resources and programs |
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| Referral | Other | Receive referrals to supportive care services |
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| Supportive Care | Other | Receive referrals to supportive care services |
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| Up to 1 year |
| Retention rate | Will be defined as the percentage of participants in the intervention arm who complete the Practical Geriatric Assessment (PGA) tool. The denominator will be all patients randomized to the intervention arm. The retention threshold will be met if ≥ 60% of these participants complete the PGA tool. Will be summarized using descriptive statistics. Rates will be estimated along with the 95% exact binomial confidence interval. | Up to 3 months after completion of study treatment |
| Acceptability of the intervention | Will be defined as the percentage of participants in the intervention arm who are referred to and seen by supportive care services. The denominator will be all patients in the intervention arm who receive geriatric assessment-guided recommendations for supportive care referrals. The acceptability threshold will be met if ≥ 60% of these participants agree to and are seen by at least one recommended service during the study period. Will be summarized using descriptive statistics. Rates will be estimated along with the 95% exact binomial confidence interval. Analyses comparing groups of participants defined by response may be conducted by various two sample tests such as two-sample t-test or Wilcoxon rank sum test for the continuous endpoints, or Chi square test / Fisher's exact test for the categorical endpoints. | Up to 3 months after completion of treatment |
| Proportion of any-grade non-hematologic treatment-related toxicities | Will be assessed in patients using CTCAE v 5.0. Will be summarized using descriptive statistics. For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided. For categorical variables, counts and percentages will be provided. Observed toxicities will be summarized by type, severity, and attribution. Rates will be estimated along with the 95% exact binomial confidence interval. | Up to 3 months after completion of treatment |
| Patient/family caregiver self-reported outcomes | Will be assessed using the geriatric assessment, Functional Assessment of Cancer Therapy-Head and Neck questionnaire, distress thermometer, Montgomery Borgatta Caregiver Burden Scale, and satisfaction with communication. Will be summarized using descriptive statistics. For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided. For categorical variables, counts and percentages will be provided. Analyses comparing groups of participants defined by response may be conducted by various two sample tests such as two-sample t-test or Wilcoxon rank sum test for the continuous endpoints, or Chi square test / Fisher's exact test for the categorical endpoints. | Up to 3 months after completion of treatment |
| Rate of unplanned readmissions | Will be summarized using descriptive statistics. Rates will be estimated along with the 95% exact binomial confidence interval. Analyses comparing groups of participants defined by response may be conducted by various two sample tests such as two-sample t-test or Wilcoxon rank sum test for the continuous endpoints, or Chi square test / Fisher's exact test for the categorical endpoints. | Up to 3 months after completion of treatment |
| Rate of emergency room/urgent care visits | Will be summarized using descriptive statistics. Rates will be estimated along with the 95% exact binomial confidence interval. Analyses comparing groups of participants defined by response may be conducted by various two sample tests such as two-sample t-test or Wilcoxon rank sum test for the continuous endpoints, or Chi square test / Fisher's exact test for the categorical endpoints. | Up to 3 months after completion of treatment |
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D058015 | Health Communication |
| D007407 | Interviews as Topic |
| D009819 | Office Visits |
| D012017 | Referral and Consultation |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D005159 | Health Care Facilities Workforce and Services |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
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