Adult Solid Neoplasm, Lymphoma, Toxicity
Conditions
Brief summary
This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing cancer treatment toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.
Detailed description
PRIMARY OBJECTIVES: I. To determine if providing information regarding geriatric assessment (GA) and GA-driven recommendations to oncology physicians reduces clinician-rated grade 3-5 toxicity in patients aged 70 and over with advanced cancer starting a new treatment regimen. SECONDARY OBJECTIVES: I. Proportion of patients who are alive at 6 months after study entry. II. Evaluate whether providing oncology physicians with information regarding GA summary and GA-driven recommendations influences clinical care of older patients receiving treatment for advanced cancer. IIA. Compare treatment decisions (as measured by relative dose intensity of the agents administered in the first cycle). IIB. Describe the number and type of GA-driven recommendations implemented for older patients starting a new treatment regimen for advanced cancer. OUTLINE: Treatment sites are randomized to 1 of 2 arms. ARM I (GA intervention): Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations. ARM II (usual care): Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams. After completion of study, patients are followed up at 4-6 weeks, at 3 and 6 months, and at 1 year.
Interventions
OTHERComprehensive Geriatric Assessment
Complete geriatric assessment
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERSurvey Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
University of Chicago
City of Hope National Medical Center
Supriya Mohile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA FOR PHYSICIANS * Oncology physicians must work at a National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practice site with no plans to leave that NCORP practice site or retire at the time of enrollment into the study * INCLUSION CRITERIA FOR PATIENTS * Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most situations, this would be a stage IV cancer; patients with a diagnosis of stage III cancer or lymphoma are eligible if cure is not possible or anticipated; clinical staging without pathological confirmation of advanced disease is allowed * Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration; the treatment regimen is up to the discretion of the treating oncology physician; the regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity; patients who will receive monoclonal antibody therapy or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if other agents present a prevalence of toxicity similar to chemotherapy; patients who are receiving approved cancer treatment in combination with radiation are eligible; a patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and
Exclusion criteria
are met. \*Chemotherapy is defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (\>50%) will be allowed. * Plan to be on chemotherapy or other allowable treatment for at least 3 months (minimum 70 days) and be willing to come in for study visits * Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy * Able to provide informed consent, or if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (or authorized representative per institutional policies) must sign consent by the baseline visit. If the participant is found to be impaired on the Blessed-Orientation Memory Concentration Test (BOMC) during screening; they must have a health care proxy or authorized representative to be eligible to enroll. * Participant has adequate understanding of the English language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experienced Any Grade 3-5 Toxicity | 3 months | Proportion of patients who experienced grade 3-5 toxicity within 3 months of initiation of new treatment regimen. Toxicity was graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduced Dose Intensity | 4-6 weeks | Proportion of patients with reduced dose intensity in cycle 1. |
| GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Baseline | The type and frequency of GA-driven recommendations implemented for older patients with impaired physical performance and starting a new treatment regimen for advanced cancer. Physical Performance measures included: Timed Up and Go, Short Physical Performance Battery, Falls History, and OARS Physical Health. |
| GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Baseline | The type and frequency of GA-driven recommendations implemented for older patients with impaired functional status and starting a new treatment regimen for advanced cancer. Functional Status measures included: Activities of Daily Living and Instrumental Activities of Daily Living. |
| GA-driven Recommendations Made Among Patients With Impaired Comorbidities. | Baseline | The type and frequency of GA-driven recommendations implemented for older patients with impaired comorbidities and starting a new treatment regimen for advanced cancer. Comorbidity measure included: OARS Comorbidity. |
| Patient Survival at 6 Months | 6 months | Proportion of patients who were alive at 6 months (183 days) after enrollment estimated by Kaplan-Meier method. |
| GA-driven Recommendations Made Among Patients With Impaired Nutrition. | Baseline | The type and frequency of GA-driven recommendations implemented for older patients with impaired nutrition and starting a new treatment regimen for advanced cancer. Nutrition measures included: Body Mass Index, Weight Loss, and Mini Nutrition Assessment. |
| GA-driven Recommendations Made Among Patients With Impaired Social Support. | Baseline | The type and frequency of GA-driven recommendations implemented for older patients with impaired social support and starting a new treatment regimen for advanced cancer. Social Support measure included: OARS Medical Social Support. |
| GA-driven Recommendations Made Among Patients With Impaired Polypharmacy. | Baseline | The type and frequency of GA-driven recommendations implemented for older patients with impaired polypharmacy and starting a new treatment regimen for advanced cancer. Polypharmacy measure included: medication review. |
| GA-driven Recommendations Made Among Patients With Impaired Psychological Status. | Baseline | The type and frequency of GA-driven recommendations implemented for older patients with impaired psychological status and starting a new treatment regimen for advanced cancer. Psychological measures included: Geriatric Depression Scale and Generalized Anxiety Disorder - 7 item scale. |
| GA-driven Recommendations Made Among Patients With Impaired Cognition. | Baseline | The type and frequency of GA-driven recommendations implemented for older patients with impaired cognition and starting a new treatment regimen for advanced cancer. Cognition measures included: Blessed Orientation Memory Concentration and Mini Cog assessments. |
Countries
United States
Participant flow
Pre-assignment details
823 patients were screened. 66 failed screening and 24 withdrew before starting the intervention
Participants by arm
| Arm | Count |
|---|---|
| Arm I (GA Intervention) Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations. | 349 |
| Arm II (Usual Care) Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams. | 369 |
| Total | 718 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 94 | 90 |
| Overall Study | Protocol Violation | 13 | 2 |
| Overall Study | Subject passively continued participation only with data obtained from their medical records | 35 | 32 |
| Overall Study | Withdrawal by Subject | 10 | 5 |
Baseline characteristics
| Characteristic | Arm II (Usual Care) | Arm I (GA Intervention) | Total |
|---|---|---|---|
| Age, Continuous | 77.2 years STANDARD_DEVIATION 5.2 | 77.2 years STANDARD_DEVIATION 5.7 | 77.2 years STANDARD_DEVIATION 5.4 |
| Age, Customized Patient categorical age 70-79 years old | 250 Participants | 244 Participants | 494 Participants |
| Age, Customized Patient categorical age 80-89 years old | 110 Participants | 94 Participants | 204 Participants |
| Age, Customized Patient categorical age 90+ years old | 8 Participants | 10 Participants | 18 Participants |
| Cancer Stage Other | 10 Participants | 3 Participants | 13 Participants |
| Cancer Stage Stage III | 35 Participants | 42 Participants | 77 Participants |
| Cancer Stage Stage IV | 324 Participants | 304 Participants | 628 Participants |
| Cancer Type Breast | 37 Participants | 19 Participants | 56 Participants |
| Cancer Type Gastrointestinal | 115 Participants | 132 Participants | 247 Participants |
| Cancer Type Genitourinary | 53 Participants | 56 Participants | 109 Participants |
| Cancer Type Gynaecological | 14 Participants | 29 Participants | 43 Participants |
| Cancer Type Lung | 116 Participants | 64 Participants | 180 Participants |
| Cancer Type Lymphoma | 23 Participants | 23 Participants | 46 Participants |
| Cancer Type Other | 11 Participants | 26 Participants | 37 Participants |
| Education High school graduate | 125 Participants | 119 Participants | 244 Participants |
| Education Less than high school | 53 Participants | 58 Participants | 111 Participants |
| Education Some college or above | 190 Participants | 171 Participants | 361 Participants |
| Education Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 365 Participants | 341 Participants | 706 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Income Declined to answer | 90 Participants | 65 Participants | 155 Participants |
| Income Less than or equal to $50,000 | 182 Participants | 189 Participants | 371 Participants |
| Income More than $50,000 | 96 Participants | 94 Participants | 190 Participants |
| Income Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Marital Status Married or Domestic Partnership | 237 Participants | 212 Participants | 449 Participants |
| Marital Status Separated, Widowed, or Divorced | 125 Participants | 125 Participants | 250 Participants |
| Marital Status Single or Never Married | 6 Participants | 11 Participants | 17 Participants |
| Marital Status Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Number GA | 4.4 Impairments STANDARD_DEVIATION 1.5 | 4.6 Impairments STANDARD_DEVIATION 1.6 | 4.5 Impairments STANDARD_DEVIATION 1.6 |
| Number of Practice Sites | 24 practice sites | 16 practice sites | 40 practice sites |
| Previous Chemo No | 277 Participants | 234 Participants | 511 Participants |
| Previous Chemo Unknown or Not Reported | 11 Participants | 11 Participants | 22 Participants |
| Previous Chemo Yes | 81 Participants | 104 Participants | 185 Participants |
| Race/Ethnicity, Customized Study-reported Race/Ethnicity Black | 12 Participants | 40 Participants | 52 Participants |
| Race/Ethnicity, Customized Study-reported Race/Ethnicity Non-Hispanic White | 347 Participants | 281 Participants | 628 Participants |
| Race/Ethnicity, Customized Study-reported Race/Ethnicity Other | 9 Participants | 26 Participants | 35 Participants |
| Race/Ethnicity, Customized Study-reported Race/Ethnicity Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 12 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 40 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 350 Participants | 285 Participants | 635 Participants |
| Region of Enrollment United States | 369 participants | 349 participants | 718 participants |
| Sex: Female, Male Female | 166 Participants | 145 Participants | 311 Participants |
| Sex: Female, Male Male | 202 Participants | 203 Participants | 405 Participants |
| Treatment Type Chemotherapy and other agents | 66 Participants | 85 Participants | 151 Participants |
| Treatment Type Multiple agent chemotherapy | 194 Participants | 141 Participants | 335 Participants |
| Treatment Type Non-chemotherapy | 41 Participants | 44 Participants | 85 Participants |
| Treatment Type Single agent chemotherapy | 68 Participants | 79 Participants | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 99 / 349 | 94 / 369 |
| other Total, other adverse events | 0 / 349 | 0 / 369 |
| serious Total, serious adverse events | 0 / 349 | 0 / 369 |
Outcome results
Primary
Patient Experienced Any Grade 3-5 Toxicity
Proportion of patients who experienced grade 3-5 toxicity within 3 months of initiation of new treatment regimen. Toxicity was graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0.
Time frame: 3 months
Population: All patients who had data collected at baseline were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (GA Intervention) | Patient Experienced Any Grade 3-5 Toxicity | 0.51 proportion of participants |
| Arm II (Usual Care) | Patient Experienced Any Grade 3-5 Toxicity | 0.71 proportion of participants |
p-value: 0.000195% CI: [0.64, 0.86]Mixed Models Analysis
Secondary
GA-driven Recommendations Made Among Patients With Impaired Cognition.
The type and frequency of GA-driven recommendations implemented for older patients with impaired cognition and starting a new treatment regimen for advanced cancer. Cognition measures included: Blessed Orientation Memory Concentration and Mini Cog assessments.
Time frame: Baseline
Population: Enrolled patients in Arm 1: GA Intervention with Impaired Cognition
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | TSH if dementia is suspected | 12 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Treatment modification: modify dosage | 68 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Assess decision-making capacity and if lacking elicit health care proxy information and input | 88 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Refer to: clinician experienced in memory care | 10 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Refer to: social work | 43 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Refer to: palliative care | 22 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Nueropsychological testing if dementia is suspected | 6 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | B12 if dementia is suspected | 12 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Brain imaging | 16 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Provide information on cognitive rehabilitation or memory care programs | 30 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Give patient/family member handout on delirium risk | 32 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Provide explicit and written instructions for appointments, medications, and treatment | 104 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Pillbox: confirm that someone else will help fill | 62 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Pillbox: separate by am, noon, pm, and night | 53 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Medication review: minimize psychoactive and high risk medications | 89 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Treatment modification: modify treatment choice | 42 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Cognition. | Treatment modification: modify treatment regimen | 61 Participants |
Secondary
GA-driven Recommendations Made Among Patients With Impaired Comorbidities.
The type and frequency of GA-driven recommendations implemented for older patients with impaired comorbidities and starting a new treatment regimen for advanced cancer. Comorbidity measure included: OARS Comorbidity.
Time frame: Baseline
Population: Enrolled patients in Arm 1: GA Intervention with Impaired Comorbidities
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Comorbidities. | Initiate direct communication with patient's primary care physician about the cancer treatment plan | 201 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Comorbidities. | Modify treatment choices: diabetes history- avoid neurotoxic agents if another option is equivalent | 45 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Comorbidities. | Modify treatment choices: heart failure history - minimize volume/infusion rate of agents | 28 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Comorbidities. | Modify treatment choices: renal impairment history - adjust as appropriate | 45 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Comorbidities. | Modify treatment choices: Modify dosage/schedule if concern about tolerance/worsening comorbidities | 113 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Comorbidities. | Provide smoking cessation counseling if the patient currently smokes | 10 Participants |
Secondary
GA-driven Recommendations Made Among Patients With Impaired Functional Status.
The type and frequency of GA-driven recommendations implemented for older patients with impaired functional status and starting a new treatment regimen for advanced cancer. Functional Status measures included: Activities of Daily Living and Instrumental Activities of Daily Living.
Time frame: Baseline
Population: Enrolled patients in Arm 1: GA Intervention with Impaired Functional Status
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Refer to: aide services | 32 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Refer to: personal emergency response information | 45 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Refer to: home nursing services | 25 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Physical Examination: check orthostatic blood pressure | 56 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Physical Examination: decrease/eliminate blood pressure meds if blood pressure is low or low normal | 40 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Medication Review: minimize psychoactive meds including those used for supportive care | 74 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Medication Review: minimize duplicative medications | 103 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Refer to: occupational therapist | 26 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Treatment modification: consider single agent rather than doublet therapy if appropriate | 72 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Treatment modification: modify dosage | 98 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Treatment modification: modify treatment regimen | 106 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Treatment modification: conduct frequent toxicity check | 173 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Inform: provide fall counselling handout | 170 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Inform: provide energy conservation handout | 162 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Functional Status. | Inform: exercise or exercise prescription | 169 Participants |
Secondary
GA-driven Recommendations Made Among Patients With Impaired Nutrition.
The type and frequency of GA-driven recommendations implemented for older patients with impaired nutrition and starting a new treatment regimen for advanced cancer. Nutrition measures included: Body Mass Index, Weight Loss, and Mini Nutrition Assessment.
Time frame: Baseline
Population: Enrolled patients in Arm 1: GA Intervention with Impaired Nutrition
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Nutrition. | Refer to: nutritionist/clinical dietician | 93 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Nutrition. | Refer to: meals-on-wheels | 13 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Nutrition. | Refer to: dentist if poor dentition or denture issues | 20 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Nutrition. | Refer to: speech and swallow if difficulty with swallowing | 10 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Nutrition. | Inform: nutrition handout | 169 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Nutrition. | Treatment modification: use caution with highly emetogenic regimens and use another if appropriate | 135 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Nutrition. | Treatment modification: utilize aggressive anti-emetic therapy | 153 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Nutrition. | Treatment modification: conduct frequent toxicity check | 192 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Nutrition. | Inform: mucositis handout | 133 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Nutrition. | Recommend saline-peroxide mouthwash if treatment has high risk of mucositis | 88 Participants |
Secondary
GA-driven Recommendations Made Among Patients With Impaired Physical Performance.
The type and frequency of GA-driven recommendations implemented for older patients with impaired physical performance and starting a new treatment regimen for advanced cancer. Physical Performance measures included: Timed Up and Go, Short Physical Performance Battery, Falls History, and OARS Physical Health.
Time frame: Baseline
Population: Enrolled patients in Arm 1: GA Intervention with Impaired Physical Performance
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Refer to: physical therapist (outpatient or home-based depending on eligibility for home care) | 74 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Refer to: occupational therapist | 35 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Refer to: aide services | 45 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Refer to: personal emergency response information | 62 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Refer to: vision specialist if difficulties | 38 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Physical Examination: check orthostatic blood pressure | 92 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Physical Examination: decrease/eliminate blood pressure meds if blood pressure is low or low normal | 67 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Medication Review: minimize psychoactive meds including those used for supportive care | 115 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Medication Review: minimize duplicative medications | 150 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Treatment modification: consider single agent rather than doublet therapy if appropriate | 105 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Treatment modification: modify dosage | 147 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Treatment modification: modify treatment regimen | 155 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Treatment modification: conduct frequent toxicity check (weekly or every other week) | 270 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Treatment modification: choose non-neurotoxic regimen for treatment over a neurotoxic regimen | 116 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Inform: provide fall counselling handout | 270 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Inform: provide energy conservation handout | 259 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Physical Performance. | Inform: exercise or exercise prescription | 262 Participants |
Secondary
GA-driven Recommendations Made Among Patients With Impaired Polypharmacy.
The type and frequency of GA-driven recommendations implemented for older patients with impaired polypharmacy and starting a new treatment regimen for advanced cancer. Polypharmacy measure included: medication review.
Time frame: Baseline
Population: Enrolled patients in Arm 1: GA Intervention with Impaired Polypharmacy
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Polypharmacy. | Ask patient to bring in prescribed, OTC medications, and supplements to review at the next visit | 158 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Polypharmacy. | Contact primary care provider to help reduce regimen complexity | 82 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Polypharmacy. | Reduce medicines solely used for hypertension or diabetes if appropriate | 59 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Polypharmacy. | Consult the pharmacist to synchronize medication refills | 52 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Polypharmacy. | Have pharmacist meet with the patient to evaluate drug interactions and medication counseling | 59 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Polypharmacy. | Provide written instructions for taking new medications | 184 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Polypharmacy. | Recommend pillbox and/or medication calendar | 123 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Polypharmacy. | Provide handout on polypharmacy | 223 Participants |
Secondary
GA-driven Recommendations Made Among Patients With Impaired Psychological Status.
The type and frequency of GA-driven recommendations implemented for older patients with impaired psychological status and starting a new treatment regimen for advanced cancer. Psychological measures included: Geriatric Depression Scale and Generalized Anxiety Disorder - 7 item scale.
Time frame: Baseline
Population: Enrolled patients in Arm 1: GA Intervention with Impaired Psychological Status
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Psychological Status. | Provide written or verbal communication with primary care physician | 44 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Psychological Status. | Refer to: counseling or psychotherapy | 20 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Psychological Status. | Refer to: social work | 42 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Psychological Status. | Refer to: spiritual counseling or Chaplaincy services | 18 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Psychological Status. | Refer to: psychiatry if severe symptoms or if already on medications which are not adequate | 11 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Psychological Status. | Refer to: palliative care if other physical and/or cancer symptoms are present | 24 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Psychological Status. | Initiate pharmacologic therapy if appropriate in conjunction with primary care provider | 18 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Psychological Status. | Provide linkage to community resources | 30 Participants |
Secondary
GA-driven Recommendations Made Among Patients With Impaired Social Support.
The type and frequency of GA-driven recommendations implemented for older patients with impaired social support and starting a new treatment regimen for advanced cancer. Social Support measure included: OARS Medical Social Support.
Time frame: Baseline
Population: Enrolled patients in Arm 1: GA Intervention with Impaired Social Support
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Social Support. | Confirm documented health care proxy is in medical record | 78 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Social Support. | Modify treatment choice and/or dosage | 67 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Social Support. | Refer or inform: ride assistance program | 22 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Social Support. | Refer or inform: social worker via on-site or visiting nurse services | 51 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Social Support. | Refer of inform: social worker via online services | 0 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Social Support. | Refer or inform: visiting nurse service or home health aide (if meets criteria) | 17 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Social Support. | Refer or inform: alternative living environments | 0 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Social Support. | Refer or inform: assistance programs | 0 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Social Support. | Refer or inform: medical insurance advising, advocacy, and negotiation | 19 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Social Support. | Refer or inform: legal assistance for economic and social needs | 6 Participants |
| Arm I (GA Intervention) | GA-driven Recommendations Made Among Patients With Impaired Social Support. | Refer or inform: community resource mobilization | 28 Participants |
Secondary
Patient Survival at 6 Months
Proportion of patients who were alive at 6 months (183 days) after enrollment estimated by Kaplan-Meier method.
Time frame: 6 months
Population: All patients who had data collected at baseline were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (GA Intervention) | Patient Survival at 6 Months | 0.71 proportion of participants |
| Arm II (Usual Care) | Patient Survival at 6 Months | 0.74 proportion of participants |
p-value: 0.3995% CI: [0.85, 1.5]Regression, Cox
Secondary
Reduced Dose Intensity
Proportion of patients with reduced dose intensity in cycle 1.
Time frame: 4-6 weeks
Population: All patients who had data collected at baseline were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (GA Intervention) | Reduced Dose Intensity | 0.49 proportion of participants |
| Arm II (Usual Care) | Reduced Dose Intensity | 0.35 proportion of participants |
p-value: 0.01595% CI: [1.06, 1.78]Mixed Models Analysis