Localized Head and Neck Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERBest Practice
Receive usual care
OTHERElectronic Health Record Review
Ancillary studies
BEHAVIORALHealth Communication
Shared with treating oncology
OTHERInterview
Ancillary studies
OTHEROffice Visit
Attend regular clinical visits
Undergo PGA
OTHERQuestionnaire Administration
Ancillary studies
OTHERReferral
Receive referrals to resources and programs
OTHERSupportive Care
Receive referrals to supportive care services
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* PATIENT: Documented written informed consent of the participant * PATIENT: Diagnosis of non-metastatic head and neck cancer * PATIENT: Age: ≥ 60 years * PATIENT: Patient must be scheduled to undergo curative-intent, definitive radiation with or without concurrent chemotherapy or postoperative radiation with or without concurrent chemotherapy * PATIENT: Patients must have at least one geriatric assessment as assessed by the modified Geriatric 8 (G8) tool * PATIENT: Family caregivers (FCGs) are highly encouraged to participate but this is not required. Patients without FCGs will be eligible to participate in the study. FCGs will be randomized to the same arm as their corresponding patients * PATIENT: Ability to read and understand English * CAREGIVER: A family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care * CAREGIVER: Ability to read and understand English * CAREGIVER: Age 18 years or older
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of grade 2-5 non-hematologic treatment-related toxicities | Up to 3 months after completion of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention rate | Up to 3 months after completion of study treatment | 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. |
| Acceptability of the intervention | Up to 3 months after completion of treatment | 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. |
| Proportion of any-grade non-hematologic treatment-related toxicities | Up to 3 months after completion of treatment | 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. |
| Percentage of eligible participants who enroll in the study | Up to 1 year | 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. |
| Rate of unplanned readmissions | Up to 3 months after completion of treatment | 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. |
| Rate of emergency room/urgent care visits | Up to 3 months after completion of treatment | 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. |
| Patient/family caregiver self-reported outcomes | Up to 3 months after completion of treatment | 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. |
Countries
United States
Outcome results
None listed