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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00619 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| URCC 13070 | Other Identifier | University of Rochester | |
| URCC-13070 | Other Identifier | DCP | |
| URCC-13070 | Other Identifier | CTEP | |
| UG1CA189961 | U.S. NIH Grant/Contract | View source | |
| U10CA037420 | U.S. NIH Grant/Contract | View source | |
| CD-12-11-4634 | Other Identifier | PCORI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Patient-Centered Outcomes Research Institute | OTHER |
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Over 60% of cancers occur in older persons, and the number of older persons with cancer is expected to grow as the population ages. Oncology clinical trials have traditionally excluded older patients with advanced cancer and chronic health conditions. In this context, where data is limited and risk from treatment is high, older patients with advanced cancer and their caregivers must understand how cancer treatment can affect quality of life in light of underlying health status. Better communication about age-related health conditions between oncologists, older patients with advanced cancer, and their caregivers may improve decision-making for cancer treatment and quality of life. A geriatric assessment (GA), a validated set of patient-centered outcomes, has been shown to identify concerns (e.g., function, cognition) important to older persons with cancer and their caregivers. In this cluster randomized clinical trial we examined whether providing a web-generated GA summary with targeted recommendations to older patients with advanced cancer, their caregivers, and their oncologists can improve communication about age-related concerns that could affect efficacy and tolerance of cancer treatment. We also determined whether the intervention improves patient-reported quality of life and patient and caregiver satisfaction.
OBJECTIVES:
I. Primary Aim - Direct Communication about Age-related Concerns: To determine if providing GA summary plus GA-driven recommendations to patients, their caregivers, and oncology physicians increases discussions about age-related issues during clinic consultation. [Patient-Centered Outcomes Research Institute (PCORI) specified]
II. Primary Aim - Patient Satisfaction with Communication about Age-related Concerns: To determine if providing geriatric assessment (GA) summary plus GA-driven recommendations to patients, their caregivers and oncology physicians improves patient satisfaction with communication with the oncology physician regarding age-related concerns. [National Cancer Institute (NCI) specified]
III. Secondary Aim - To determine whether initially providing patients, their caregivers, and oncology physicians with GA summary plus GA-driven recommendations prior to their treatment influences quality of life of older patients receiving treatment and their caregivers.
IV. Secondary Aim - To determine whether providing patients, their caregivers, and oncology physicians with GA summary plus GA-driven recommendations influences caregiver satisfaction with communication about age-related issues.
OUTLINE: Patients are randomized to 1 of 2 arms.
Arm I: At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA and receive the GA summary plus GA targeted recommendations which is provided to the oncology team to discuss and implement if they so choose.
Arm II: At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA (no GA summary or recommendations are provided).
Patients are followed at 4-6 weeks, 3 months, and 6 months. Survival data will be collected at 1 year after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I: Geriatric Assessment Intervention | Experimental | At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA and receive the intervention; GA summary plus GA targeted recommendations which is provided to the oncology team to discuss and implement if they so choose. |
|
| Arm II: Usual Care | Active Comparator | At the first study visit with their oncologist, patients and their caregivers (if participating) complete the GA (no GA summary or recommendations are provided). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geriatric Assessment Summary | Behavioral | Complete summary of results from the Geriatric Assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Direct Communication About Age-related Concerns: Number of Discussions Related to the Geriatric Assessment That Occur in the Clinic Visit Between the Patient, Oncology Physician, and Caregiver. [Patient-Centered Outcomes Research Institute Specified] | A geriatric assessment (GA), a validated set of patient-centered outcomes, has been shown to identify concerns (e.g., function, cognition) important to older persons with cancer and their caregivers. The geriatric assessment was used to define which age related topics discussed between patients and providers would be coded. We will apply linear mixed model methodology. The total number of conversations will be the response, and the arm will be the fixed effect. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using a F test. The specific NCORP practice site differences will be assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each NCORP. | Baseline |
| Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified] | Will apply linear mixed model methodology. The total HCCQ scores will be the response, and the arm will be the fixed effect. HCCQ contains 7 questions, scale: 0-28. The higher the score the more satisfied the patients is with communication with their oncologists about age related concerns. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using a F test. The specific NCORP practice site differences will be assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each NCORP. | Within 1-7 days of the baseline audio-recorded clinic consultation |
| Measure | Description | Time Frame |
|---|---|---|
| Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Quality of Life of Older Patients Receiving Treatment and Their Caregivers. | Patient Health Related Quality of Life (HRQoL) will be assessed with the Functional Assessment of Cancer Therapy-General (FACT-G) measured on a 0-108 scale with higher scores indicating a better outcome. We will apply linear mixed model methodology to compare the between arm differences. |
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Inclusion Criteria for Patients
Exclusion Criteria for Patients
Inclusion Criteria for Caregivers
Exclusion Criteria for Caregivers
-Caregivers unable to understand the consent form due to cognitive, health, or sensory impairment will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Supriya Mohile | University of Rochester NCORP Research Base | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States | ||
| Delaware/Christiana Care NCORP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39260086 | Derived | Kehoe LA, Sohn MB, Wang L, Mohile S, Kamen C, Van Orden K, Wells M, Gilmore N, Arana-Chicas E, Gudina A, Yilmez S, Griggs L, Loh KP. Associations of quality of social support and accurate beliefs about curability among older adults with advanced cancer. J Geriatr Oncol. 2024 Nov;15(8):102061. doi: 10.1016/j.jgo.2024.102061. Epub 2024 Sep 10. | |
| 38898664 | Derived | Singhal S, Wang Y, Qin Z, Peterson DR, Dunne RF, Culakova E, Hopkins JO, Melnyk N, Onitilo A, Targia V, Mohile S, Loh KP. Nutritional impairment, psychological health and quality of life among older adults with advanced cancer: A secondary analysis of a randomized clinical trial. Cancer Med. 2024 Jun;13(12):e7348. doi: 10.1002/cam4.7348. |
| Label | URL |
|---|---|
| Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (GA Informational Intervention) | Patients and their caregivers (if participating) complete the GA and receive the GA summary and recommendations guided by GA results provided by the oncology team to discuss and implement for each age-related issue at baseline. Informational Intervention: Complete GA summary plus GA-driven recommendations |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2017 | Jun 27, 2018 |
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| Geriatric Assessment Targeted Recommendations | Behavioral | Recommendations are made based on areas patients were impaired in on the Geriatric Assessment. They include referrals, tests, medication review, instructions, and support services. The choice of which recommendation to implement is left to the discretion of the physician. Treatment modifications |
|
| Geriatric Assessment (GA) | Behavioral | A GA measures the issues important to older patients, including function, psychological status, cognitive abilities, social support, and the impact of medical problems on quality of life. |
|
| Mean score over 4-6 weeks, 3 months, 6 months assessments following the intervention |
| Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Caregiver Satisfaction With Communication About Age-related Issues. | We will compare the effect of the intervention on caregiver satisfaction (the modified health care climate questionnaire (HCCQ)- age for the caregiver, range 0-20; higher score better outcome). We will apply linear mixed model methodology to compare between arm differences. | At 4-6 weeks, 3 months and 6 months following the intervention |
| Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Quality of Life of Older Patients Receiving Treatment and Their Caregivers. | Caregiver Health Related Quality of Life (burden) will be assessed with the Caregiver Reactions Assessment (CRA- [Overall scale ranges from 1-5, better or worse outcome depending on subscale- Self Esteem Subscale higher score indicates better outcome, Disrupted Schedule subscale lower score indicates better outcome, Financial problems subscale lower score indicates better outcome, Lack of Social Support subscale lower score indicates better outcome, Health Problems subscale lower score indicates better outcome]). We will apply linear mixed model methodology to compare between arm differences | Mean 4-6 weeks, 3 months, and 6 months after the intervention |
| Newark |
| Delaware |
| 19713 |
| United States |
| Hawaii | Honolulu | Hawaii | 96813 | United States |
| University of Chicago Comprehensive Cancer Center | 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 |
| Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| Metro-Minnesota NCORP | Minneapolis | Minnesota | 55426 | United States |
| Nevada NCORP | Las Vegas | Nevada | 89106 | United States |
| Northwell Health | Lake Success | New York | 11042 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Southeast Clinical Oncology Research Consortium | Winston-Salem | North Carolina | 27104 | United States |
| Columbus NCORP | Columbus | Ohio | 43215 | United States |
| Pacific Cancer Research Consortium Ncorp | Portland | Oregon | 97213 | United States |
| Geisinger Cancer Institute NCORP | Danville | Pennsylvania | 17822 | United States |
| Greenville NCORP | Greenville | South Carolina | 29615 | United States |
| WiNCORP | Marshfield | Wisconsin | 54449 | United States |
| Aurora NCORP | Milwaukee | Wisconsin | 53226 | United States |
| 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. |
| 37897888 | Derived | Jensen-Battaglia M, Mohammed M, Loh KP, Wells M, Tylock R, Ramsdale E, Canin B, Geer J, O'Rourke MA, Liu JJ, Seplaki CL, Mohile SG, Wildes TM. Modifiable fall risk factors among older adults with advanced cancer: Secondary analysis of a cluster-randomized clinical trial. J Geriatr Oncol. 2023 Nov;14(8):101650. doi: 10.1016/j.jgo.2023.101650. Epub 2023 Oct 26. |
| 35984998 | Derived | Jensen-Battaglia M, Lei L, Xu H, Loh KP, Wells M, Tylock R, Ramsdale E, Kleckner AS, Mustian KM, Dunne RF, Kehoe L, Bearden J 3rd, Burnette BL, Whitehead M, Mohile SG, Wildes TM. Communication About Fall Risk in Community Oncology Practice: The Role of Geriatric Assessment. JCO Oncol Pract. 2022 Oct;18(10):e1630-e1640. doi: 10.1200/OP.22.00173. Epub 2022 Aug 19. |
| 35302628 | Derived | Jensen-Battaglia M, Lei L, Xu H, Kehoe L, Patil A, Loh KP, Ramsdale E, Magnuson A, Kleckner AS, Wildes TM, Lin PJ, Mustian KM, Giri G, Whitehead M, Bearden J 3rd, Burnette BL, Geer J, Mohile SG, Dunne RF. Association of Oncologist-Patient Communication With Functional Status and Physical Performance in Older Adults: A Secondary Analysis of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e223039. doi: 10.1001/jamanetworkopen.2022.3039. |
| 35179585 | Derived | Loh KP, Seplaki CL, Sanapala C, Yousefi-Nooraie R, Lund JL, Epstein RM, Duberstein PR, Flannery M, Culakova E, Xu H, McHugh C, Klepin HD, Lin PJ, Watson E, Grossman VA, Liu JJ, Geer J, O'Rourke MA, Mustian K, Mohile SG. Association of Prognostic Understanding With Health Care Use Among Older Adults With Advanced Cancer: A Secondary Analysis of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220018. doi: 10.1001/jamanetworkopen.2022.0018. |
| 34762734 | Derived | Gilmore N, Xu H, Kehoe L, Kleckner AS, Moorthi K, Lei L, Mohamed MRS, Loh KP, Culakova E, Flannery M, Ramsdale E, Duberstein PR, Canin B, Kamen C, Giri G, Watson E, Patil A, Onitilo AA, Burnette B, Janelsins M, Mohile SG. Evaluating the association of frailty with communication about aging-related concerns between older patients with advanced cancer and their oncologists. Cancer. 2022 Mar 1;128(5):1101-1109. doi: 10.1002/cncr.34010. Epub 2021 Nov 11. |
| 34371137 | Derived | Flannery MA, Mohile S, Culakova E, Norton S, Kamen C, Dionne-Odom JN, DiGiovanni G, Griggs L, Bradley T, Hopkins JO, Liu JJ, Loh KP. Completion of Patient-Reported Outcome Questionnaires Among Older Adults with Advanced Cancer. J Pain Symptom Manage. 2022 Feb;63(2):301-310. doi: 10.1016/j.jpainsymman.2021.07.032. Epub 2021 Aug 8. |
| 34228510 | Derived | Kleckner AS, Wells M, Kehoe LA, Gilmore NJ, Xu H, Magnuson A, Dunne RF, Jensen-Battaglia M, Mohamed MR, O'Rourke MA, Vogelzang NJ, Dib EG, Peppone LJ, Mohile SG. Using Geriatric Assessment to Guide Conversations Regarding Comorbidities Among Older Patients With Advanced Cancer. JCO Oncol Pract. 2022 Jan;18(1):e9-e19. doi: 10.1200/OP.21.00196. Epub 2021 Jul 6. |
| 33858803 | Derived | Xu H, Kadambi S, Mohile SG, Yang S, Kehoe LA, Wells M, Culakova E, Kamen C, Obrecht S, Mohamed M, Gilmore NJ, Magnuson A, Grossman VA, Hopkins JO, Geer J, Berenberg J, Mustian K, Cupertino A, Mohile N, Loh KP. Caregiving burden of informal caregivers of older adults with advanced cancer: The effects of rurality and education. J Geriatr Oncol. 2021 Sep;12(7):1015-1021. doi: 10.1016/j.jgo.2021.04.002. Epub 2021 Apr 12. |
| 31697365 | Derived | Mohile SG, Epstein RM, Hurria A, Heckler CE, Canin B, Culakova E, Duberstein P, Gilmore N, Xu H, Plumb S, Wells M, Lowenstein LM, Flannery MA, Janelsins M, Magnuson A, Loh KP, Kleckner AS, Mustian KM, Hopkins JO, Liu JJ, Geer J, Gorawara-Bhat R, Morrow GR, Dale W. Communication With Older Patients With Cancer Using Geriatric Assessment: A Cluster-Randomized Clinical Trial From the National Cancer Institute Community Oncology Research Program. JAMA Oncol. 2020 Feb 1;6(2):196-204. doi: 10.1001/jamaoncol.2019.4728. |
| 30924548 | Derived | Kehoe LA, Xu H, Duberstein P, Loh KP, Culakova E, Canin B, Hurria A, Dale W, Wells M, Gilmore N, Kleckner AS, Lund J, Kamen C, Flannery M, Hoerger M, Hopkins JO, Liu JJ, Geer J, Epstein R, Mohile SG. Quality of Life of Caregivers of Older Patients with Advanced Cancer. J Am Geriatr Soc. 2019 May;67(5):969-977. doi: 10.1111/jgs.15862. Epub 2019 Mar 29. |
| FG001 |
| Arm II (Usual Care) |
Patients and their caregivers (if participating) complete the GA at baseline. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (GA Informational Intervention) | Patients and their caregivers (if participating) complete the GA and receive the GA summary and recommendations guided by GA results provided by the oncology team to discuss and implement for each age-related issue at baseline. Informational Intervention: Complete GA summary plus GA-driven recommendations |
| BG001 | Arm II (Usual Care) | Patients and their caregivers (if participating) complete the GA at baseline. |
| 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 | One subject did not provide demographic information in Arm I. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex/Gender, Customized | 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 |
| ||||||||||||||||
| 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 |
| |||||||||||||||
| GA Impairments | There are 8 different GA domains in which impairments are measured, they include psychological status, cognition, social support, functional status, nutrition, co-morbidity, 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 | GA impairments |
| ||||||||||||||
| Number of Practice Sites | Number | participants |
|
| 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 | Direct Communication About Age-related Concerns: Number of Discussions Related to the Geriatric Assessment That Occur in the Clinic Visit Between the Patient, Oncology Physician, and Caregiver. [Patient-Centered Outcomes Research Institute Specified] | A geriatric assessment (GA), a validated set of patient-centered outcomes, has been shown to identify concerns (e.g., function, cognition) important to older persons with cancer and their caregivers. The geriatric assessment was used to define which age related topics discussed between patients and providers would be coded. We will apply linear mixed model methodology. The total number of conversations will be the response, and the arm will be the fixed effect. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using a F test. The specific NCORP practice site differences will be assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each NCORP. | All baseline patients who were evaluable for this primary aim were included in this analysis.
| Posted | Least Squares Mean | 95% Confidence Interval | Number of Conversations | Baseline |
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| Primary | Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified] | Will apply linear mixed model methodology. The total HCCQ scores will be the response, and the arm will be the fixed effect. HCCQ contains 7 questions, scale: 0-28. The higher the score the more satisfied the patients is with communication with their oncologists about age related concerns. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using a F test. The specific NCORP practice site differences will be assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each NCORP. | All baseline patients who were evaluable for this primary aim were included in this analysis.
| Posted | Least Squares Mean | 95% Confidence Interval | HCCQ total score | Within 1-7 days of the baseline audio-recorded clinic consultation |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Quality of Life of Older Patients Receiving Treatment and Their Caregivers. | Patient Health Related Quality of Life (HRQoL) will be assessed with the Functional Assessment of Cancer Therapy-General (FACT-G) measured on a 0-108 scale with higher scores indicating a better outcome. We will apply linear mixed model methodology to compare the between arm differences. | Enrolled patients who have completed the FACT-G | Posted | Least Squares Mean | Standard Error | units on a scale | Mean score over 4-6 weeks, 3 months, 6 months assessments following the intervention |
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| Secondary | Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Caregiver Satisfaction With Communication About Age-related Issues. | We will compare the effect of the intervention on caregiver satisfaction (the modified health care climate questionnaire (HCCQ)- age for the caregiver, range 0-20; higher score better outcome). We will apply linear mixed model methodology to compare between arm differences. | The number of caregiver's with an available HCCQ at 4-6 weeks | Posted | Least Squares Mean | Standard Error | score on a scale | At 4-6 weeks, 3 months and 6 months following the intervention |
|
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| Secondary | Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Quality of Life of Older Patients Receiving Treatment and Their Caregivers. | Caregiver Health Related Quality of Life (burden) will be assessed with the Caregiver Reactions Assessment (CRA- [Overall scale ranges from 1-5, better or worse outcome depending on subscale- Self Esteem Subscale higher score indicates better outcome, Disrupted Schedule subscale lower score indicates better outcome, Financial problems subscale lower score indicates better outcome, Lack of Social Support subscale lower score indicates better outcome, Health Problems subscale lower score indicates better outcome]). We will apply linear mixed model methodology to compare between arm differences | The number of caregivers with a CRA | Posted | Least Squares Mean | Standard Error | units on a scale | Mean 4-6 weeks, 3 months, and 6 months after the intervention |
|
Patients were followed for 6 months post-baseline during which time adverse events were collected.
Not provided
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 Informational Intervention) | Patients and their caregivers (if participating) complete the GA and receive the GA summary and recommendations guided by GA results provided by the oncology team to discuss and implement for each age-related issue at baseline. Informational Intervention: Complete GA summary plus GA-driven recommendations | 42 | 296 | 0 | 296 | 0 | 296 |
| EG001 | Arm II (Usual Care) | Patients and their caregivers (if participating) complete the GA at baseline. | 30 | 250 | 0 | 250 | 0 | 250 |
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Supriya Mohile, Professor of Medicine | University of Rochester, Medical Center | 585-275-0394 | URCC_COACH@URMC.Rochester.edu |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 21, 2018 | Jun 25, 2018 | SAP_000.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
|
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|
Patients and their caregivers (if participating) complete the GA at baseline. |
|
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| Counts |
|---|
| Participants |
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| Participants |
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