| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01904 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| URCC13059 | Other Identifier | University of Rochester | |
| URCC-13059 | Other Identifier | DCP | |
| URCC-13059 | Other Identifier | CTEP | |
| UG1CA189961 | U.S. NIH Grant/Contract | View source | |
| U10CA037420 | U.S. NIH Grant/Contract | View source | |
| R01CA177592 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of Chicago | OTHER |
| City of Hope National Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (GA intervention) | Experimental | Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations. |
|
| Arm II (usual care) | No Intervention | Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Geriatric Assessment | Other | Complete geriatric assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival at 6 Months | Proportion of patients who were alive at 6 months (183 days) after enrollment estimated by Kaplan-Meier method. | 6 months |
| Reduced Dose Intensity | Proportion of patients with reduced dose intensity in cycle 1. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Supriya Mohile | University of Rochester NCORP Research Base | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Delaware/Christiana Care NCORP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41784985 | Derived | Richardson DR, Wang Y, Flannery M, Mohamed M, Magnuson A, Wells M, Tylock R, Soto-Perez-de-Celis E, DuMontier C, Dale W, Epstein R, Berenberg J, Ramdin N, Mohile S, Loh KP. Outcomes of Older Adults With Advanced Cancer Who Prefer Quality of Life vs Prolonging Survival: A Secondary Analysis of the GAP70+ Cluster Randomized Clinical Trial. JAMA Oncol. 2026 May 1;12(5):517-521. doi: 10.1001/jamaoncol.2026.0072. | |
| 41389716 | Derived | Hryniv S, Gilbride E, Consagra W, Mohile S, Yilmaz S, Kyi K, Kadambi S, Jensen-Battaglia M, Gilmore N, Whitehead M, Khatri J, Braiteh FS, Conlin A, Loh KP, Magnuson A. Exploring decisional control preferences in older patients with cancer and their caregivers. J Geriatr Oncol. 2026 Mar;17(2):102832. doi: 10.1016/j.jgo.2025.102832. Epub 2025 Dec 12. |
Not provided
Not provided
823 patients were screened. 66 failed screening and 24 withdrew before starting the intervention
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (GA Intervention) | Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations. |
| FG001 | Arm II (Usual Care) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2016 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Survey Administration | Other | Ancillary studies |
|
| 4-6 weeks |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| Newark |
| Delaware |
| 19713 |
| United States |
| Hawaii MU-NCORP | Honolulu | Hawaii | 96813 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Heartland NCORP | Decatur | Illinois | 62526 | United States |
| Kansas City NCORP | Prairie Village | Kansas | 66208 | United States |
| Wichita NCORP | Wichita | Kansas | 67214 | United States |
| Gulf South MU-NCORP | New Orleans | Louisiana | 70112 | United States |
| Cancer Research Consortium of West Michigan | Grand Rapids | Michigan | 49503 | United States |
| Metro Minnesota NCORP | Minneapolis | Minnesota | 55426 | United States |
| Kansas City NCORP | Kansas City | Missouri | 64131 | United States |
| Nevada NCORP | Las Vegas | Nevada | 89106 | United States |
| North Shore LIJ Health System NCORP | Lake Success | New York | 11042 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Southeast Clinical Oncology Research Program | Winston-Salem | North Carolina | 27104 | United States |
| Columbus NCORP | Columbus | Ohio | 43215 | United States |
| Dayton NCORP | Dayton | Ohio | 45420 | United States |
| Pacific Cancer Research Consortium Ncorp | Portland | Oregon | 97213 | United States |
| Geisinger Cancer Institute NCORP | Danville | Pennsylvania | 17822 | United States |
| NCORP of the Carolinas | Greenville | South Carolina | 29615 | United States |
| Northwest NCORP | Tacoma | Washington | 98405-0986 | United States |
| Wisconsin NCORP | Marshfield | Wisconsin | 54449 | United States |
| Aurora NCORP | Milwaukee | Wisconsin | 53226 | United States |
| 41123568 | Derived | Flannery MA, Zhang Z, Culakova E, Loh KP, Canin B, Tylock RG, Stauffer FA, Mohamed M, Sun H, Mohile S. Decision regret in older adults with advanced cancer receiving systemic therapy: Associations with patient-reported and clinician-rated tolerability metrics. Cancer. 2025 Oct 15;131 Suppl 2(Suppl 2):e70023. doi: 10.1002/cncr.70023. |
| 40450795 | Derived | Jensen-Battaglia M, Delmerico A, Mohamed M, Tylock R, Flannery M, Burnette BL, Desai N, Anthony N, Mustian K, Loh KP, Mohile SG, Seplaki CL, Gilmore N. Fatigue, physical function, and the context of social vulnerability for older adults with cancer. J Geriatr Oncol. 2025 Jul;16(6):102284. doi: 10.1016/j.jgo.2025.102284. Epub 2025 May 31. |
| 40088865 | Derived | Ramsdale E, Zhou Y, Smith L, Xu H, Tylock R, Flannery M, Mohile S, Anand A. Unsupervised learning to identify symptom clusters in older adults undergoing chemotherapy. J Geriatr Oncol. 2025 Apr;16(3):102222. doi: 10.1016/j.jgo.2025.102222. Epub 2025 Mar 14. |
| 39294452 | Derived | Mohamed MR, Juba K, Awad H, Flannery M, Culakova E, Wells M, Cacciatore J, Jensen-Battaglia M, Mohile S, Ramsdale E. Effect of polypharmacy and potentially inappropriate medications on physical functional decline among older adults with advanced cancer receiving systemic treatment. Support Care Cancer. 2024 Sep 19;32(10):674. doi: 10.1007/s00520-024-08877-6. |
| 38564692 | Derived | Lund JL, Cacciatore J, Tylock R, Su IH, Sharma S, Hinton SP, Smith S, Nowels MA, Chen X, Duberstein PR, Hanson LC, Mohile SG. Development and Evaluation of a Multisource Approach to Extend Mortality Follow-Up for Older Adults With Advanced Cancer Enrolled in Randomized Trials. JCO Clin Cancer Inform. 2024 Apr;8:e2300183. doi: 10.1200/CCI.23.00183. |
| 37084629 | Derived | Ramsdale E, Kunduru M, Smith L, Culakova E, Shen J, Meng S, Zand M, Anand A. Supervised learning applied to classifying fallers versus non-fallers among older adults with cancer. J Geriatr Oncol. 2023 May;14(4):101498. doi: 10.1016/j.jgo.2023.101498. Epub 2023 Apr 19. |
| 36947036 | Derived | Xu H, Mohamed M, Flannery M, Peppone L, Ramsdale E, Loh KP, Wells M, Jamieson L, Vogel VG, Hall BA, Mustian K, Mohile S, Culakova E. An Unsupervised Machine Learning Approach to Evaluating the Association of Symptom Clusters With Adverse Outcomes Among Older Adults With Advanced Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e234198. doi: 10.1001/jamanetworkopen.2023.4198. |
| 36898361 | Derived | Mohamed MR, Loh KP, Mohile SG, Sohn M, Webb T, Wells M, Yilmaz S, Tylock R, Culakova E, Magnuson A, Sun CL, Bearden J, Hopkins JO, Faller BA, Klepin HD. External Validation of Risk Factors for Unplanned Hospitalization in Older Adults With Advanced Cancer Receiving Chemotherapy. J Natl Compr Canc Netw. 2023 Mar;21(3):273-280.e3. doi: 10.6004/jnccn.2022.7094. |
| 36692475 | Derived | Mohamed MR, Mohile SG, Juba KM, Awad H, Wells M, Loh KP, Flannery M, Culakova E, Tylock RG, Ramsdale EE. Association of polypharmacy and potential drug-drug interactions with adverse treatment outcomes in older adults with advanced cancer. Cancer. 2023 Apr 1;129(7):1096-1104. doi: 10.1002/cncr.34642. Epub 2023 Jan 24. |
| 36356279 | Derived | Culakova E, Mohile SG, Peppone L, Ramsdale E, Mohamed M, Xu H, Wells M, Tylock R, Java J, Loh KP, Magnuson A, Jamieson L, Vogel V, Duberstein PR, Chapman BP, Dale W, Flannery MA. Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. J Clin Oncol. 2023 Feb 1;41(4):835-846. doi: 10.1200/JCO.22.00738. Epub 2022 Nov 10. |
| 35433441 | Derived | Presley CJ, Mohamed MR, Culakova E, Flannery M, Vibhakar PH, Hoyd R, Amini A, VanderWalde N, Wong ML, Tsubata Y, Spakowicz DJ, Mohile SG. A Geriatric Assessment Intervention to Reduce Treatment Toxicity Among Older Adults With Advanced Lung Cancer: A Subgroup Analysis From a Cluster Randomized Controlled Trial. Front Oncol. 2022 Mar 31;12:835582. doi: 10.3389/fonc.2022.835582. eCollection 2022. |
| 34741815 | Derived | Mohile SG, Mohamed MR, Xu H, Culakova E, Loh KP, Magnuson A, Flannery MA, Obrecht S, Gilmore N, Ramsdale E, Dunne RF, Wildes T, Plumb S, Patil A, Wells M, Lowenstein L, Janelsins M, Mustian K, Hopkins JO, Berenberg J, Anthony N, Dale W. Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study. Lancet. 2021 Nov 20;398(10314):1894-1904. doi: 10.1016/S0140-6736(21)01789-X. Epub 2021 Nov 3. |
| 34272204 | Derived | Mohamed MR, Kyi K, Mohile SG, Xu H, Culakova E, Loh KP, Flannery M, Obrecht S, Ramsdale E, Patil A, Dunne RF, DiGiovanni G, Hezel A, Burnette B, Desai N, Giguere J, Magnuson A. Prevalence of and factors associated with treatment modification at first cycle in older adults with advanced cancer receiving palliative treatment. J Geriatr Oncol. 2021 Nov;12(8):1208-1213. doi: 10.1016/j.jgo.2021.06.007. Epub 2021 Jul 14. |
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
| COMPLETED |
|
| NOT COMPLETED |
|
|
There were 15 protocol violations, 13 in Arm I and 2 in Arm II.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (GA Intervention) | Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 2 patients did not report age, 1 from each arm. | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Customized | 2 patients did not report age, 1 from each arm. | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | 2 patients did not report sex, 1 from each arm. | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Marital Status | Count of Participants | Participants |
| ||||||||||||||||
| Education | Count of Participants | Participants |
| ||||||||||||||||
| Income | Count of Participants | Participants |
| ||||||||||||||||
| Cancer Type | Count of Participants | Participants |
| ||||||||||||||||
| Cancer Stage | A diagnosis of advanced solid, incurable stage III or IV cancer was part of the eligibility criteria. Clinical staging without pathological confirmation of advanced disease was allowed. Cancer stage was collected on the "Tumor & Treatment Characteristics" measure, which is completed at baseline by the clinical research associate under the direction of the oncology physician. | Count of Participants | Participants |
| |||||||||||||||
| Previous Chemo | Patient received chemotherapy before enrollment. | Count of Participants | Participants |
| |||||||||||||||
| Treatment Type | Type of cancer treatment the patient received. Chemotherapy is defined as cytotoxic drugs. Other agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (>50%) were also eligible. | Count of Participants | Participants |
| |||||||||||||||
| Number GA | There are 8 different GA domains in which impairments are measured; they include psychological status, cognition, social support, functional status, nutrition, comorbidity, polypharmacy, and physical performance. The total number of GA-domain impairments were calculated. The total number of possible impairments range from 1-8 (patients had to have at least 1 GA impairment to be eligible for the study). | Mean | Standard Deviation | Impairments |
| ||||||||||||||
| Number of Practice Sites | Number | practice sites |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All patients who had data collected at baseline were included in this analysis. | Posted | Number | proportion of participants | 3 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Survival at 6 Months | Proportion of patients who were alive at 6 months (183 days) after enrollment estimated by Kaplan-Meier method. | All patients who had data collected at baseline were included in this analysis. | Posted | Number | proportion of participants | 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Reduced Dose Intensity | Proportion of patients with reduced dose intensity in cycle 1. | All patients who had data collected at baseline were included in this analysis. | Posted | Number | proportion of participants | 4-6 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Enrolled patients in Arm 1: GA Intervention with Impaired Physical Performance | Posted | Count of Participants | Participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Enrolled patients in Arm 1: GA Intervention with Impaired Functional Status | Posted | Count of Participants | Participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Enrolled patients in Arm 1: GA Intervention with Impaired Comorbidities | Posted | Count of Participants | Participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Enrolled patients in Arm 1: GA Intervention with Impaired Cognition | Posted | Count of Participants | Participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Enrolled patients in Arm 1: GA Intervention with Impaired Nutrition | Posted | Count of Participants | Participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Enrolled patients in Arm 1: GA Intervention with Impaired Social Support | Posted | Count of Participants | Participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Enrolled patients in Arm 1: GA Intervention with Impaired Polypharmacy | Posted | Count of Participants | Participants | Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Enrolled patients in Arm 1: GA Intervention with Impaired Psychological Status | Posted | Count of Participants | Participants | Baseline |
|
|
6 months
Numbers reported in this section account for all patients who had documented date of death within 183 days from the study enrollment. Note that there were 15 protocol violations, 13 in Arm I and 2 in Arm II, and these patients are not included in the at risk group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (GA Intervention) | Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations. | 99 | 349 | 0 | 349 | 0 | 349 |
| EG001 | 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. | 94 | 369 | 0 | 369 | 0 | 369 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Supriya Mohile, Professor of Medicine | University of Rochester, Medical Center | 585-275-0394 | URCC_GAP70@urmc.rochester.edu |
| Apr 10, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2019 | Apr 10, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015577 | Geriatric Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|