A geriatric assessment (GA) intervention to reduce treatment toxicity in older patients with advanced cancer: A University of Rochester Cancer Center NCI community oncology research program cluster randomized clinical trial (CRCT).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12009-12009 ◽  
Author(s):  
Supriya Gupta Mohile ◽  
Mostafa Refaat Mohamed ◽  
Eva Culakova ◽  
Huiwen Xu ◽  
Kah Poh Loh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cancer Treatment ◽  
Usual Care ◽  
Advanced Cancer ◽  
Older Patients ◽  
Treatment Intensity ◽  
Treatment Toxicity ◽  
Oncology Research ◽  
Community Oncology ◽  
Grade 3

12009 Background: GA evaluates aging-related domains (e.g., function) known to be associated with cancer treatment toxicity. In this CRCT, we evaluated if providing a GA summary with management recommendations to oncologists can reduce toxicity in older patients (pts) with advanced cancer receiving chemotherapy and/or other agents with a high reported prevalence of grade 3-5 toxicity. Methods: Pts aged > 70 with incurable solid tumors or lymphoma and > 1 impaired GA domain starting a new treatment regimen were enrolled. Community oncology practices were randomized to intervention (oncologists received GA summary/recommendations for impairments) or usual care (none given). The primary outcome was proportion of pts who experienced any grade 3-5 toxicity (CTCAE v.4) within 3 months. Practice staff prospectively captured toxicities; blinded oncology clinicians reviewed medical records to verify. Secondary outcomes included 6 month overall survival (OS) and treatment intensity (standard vs reduced). Outcomes were analyzed using generalized linear mixed/Cox models with Arm as a fixed effect, controlling for practice. Results: From 2013-19, 718 pts were enrolled from 41 practices. Age (mean 77 yrs), sex (43% women), number of impaired GA domains (median 4/8), and treatment type (chemotherapy 88%) were not different by Arm. More pts in intervention were Black (12% vs 3%, p<0.01), had GI cancer (38% vs 31%, p<0.01), and had prior chemotherapy (31% vs 23%, p=0.02). Pts in intervention experienced a lower proportion of grade 3-5 toxicity (175/349; 50%) than pts in usual care (262/369; 71%). The relative risk (RR: intervention vs usual care) of grade 3-5 toxicity was 0.74 (95% CI: 0.63-0.87; p=0.0002); the difference was mostly driven by non-heme toxicities (RR 0.73; 95% CI: 0.53-1.0, p<0.05). OS was not significantly different (71% vs 74%, p=0.3). More pts in intervention received reduced intensity treatment at cycle 1 (49% vs 35%, RR 0.81, p=0.01). Dose modifications due to toxicity were lower in intervention (42% vs 58%, p<0.0001), but results were not significant after controlling for practice (RR 0.85; 95% CI: 0.67-1.08, p=0.2). Conclusions: Providing GA information to oncologists reduces the proportion of older pts who experience grade 3-5 toxicity from high-risk palliative cancer treatment, without compromising OS. Reduced treatment intensity at cycle 1 may explain these results. Funding: R01CA177592, U01CA233167, UG1CA189961. Clinical trial information: NCT02054741 .

A geriatric assessment (GA) intervention for older patients with advanced cancer: Secondary outcomes from a University of Rochester cancer center NCI community oncology research program cluster randomized controlled trial (CRCT).

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 33-33
Author(s):  
Supriya Gupta Mohile ◽  
Mostafa Mohamed ◽  
Huiwen Xu ◽  
Amita Patil ◽  
Eva Culakova ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Older Patients ◽  
Controlled Trial ◽  
Depression Scale ◽  
Cancer Center ◽  
Oncology Research ◽  
Community Oncology ◽  
Treatment Type ◽  
Patient Reported ◽  
Secondary Outcomes

33 Background: GA evaluates aging-related domains (e.g., function) known to be associated with cancer treatment toxicity. We found that providing a GA summary with management recommendations to oncologists reduces clinician-rated toxicity in older patients (pts) with advanced cancer receiving high risk treatment (presented @ASCO2020). Herein, we report secondary outcomes on the effects of the GA intervention on aging-related outcomes. Methods: Pts aged ≥ 70 with incurable solid tumors or lymphoma and ≥ 1 impaired GA domain starting a new treatment regimen were enrolled. Community oncology practices were randomized to intervention (oncologists received GA summary/recommendations) or usual care (none given). Secondary analyses examined effects of the intervention on functional outcomes (patient-reported falls, instrumental activities of daily living (IADL), short physical performance battery (SPPB), geriatric depression scale (GDS), and medications [total and prescription]). Outcomes were analyzed using linear mixed effects model, logistic or Poisson regression adjusted for baseline values, time, and site effects as appropriate. Results: From 2013-19, 718 pts were enrolled from 41 practices. Age (mean 77 yrs), sex (43% women), number of impaired GA domains (median 4/8), and treatment type (chemotherapy 88%) were not different by arm. More pts in intervention were black (12% vs 3%, p<0.01), had GI cancer (38% vs 31%, p<0.01), and had prior chemotherapy (31% vs 23%, p=0.02). Overall, 16.4% of all pts had one new fall over 3 months; patients in the intervention arm were significantly less like to fall over 3 months (11.7% vs 20.7%; Risk Ratio 0.58; 95% CI 0.40-0.84, p=0.004). There was no difference in the total number of medications (mean 5.86 vs 5.79, p=0.80) and prescriptions (mean 4.26 vs 4.20, p=0.70) at baseline. More medications (adjusted mean 0.23 vs 0.09, p=0.03) and prescriptions (0.19 vs 0.07, p=0.05) were discontinued during intervention, although there was no difference at 3 month follow up. There were no significant between-arms differences in IADL, SPPB, and GDS. Conclusions: Providing GA information to oncologists reduces the proportion of older pts who experience a fall over 3 months and improves polypharmacy; both of these endpoints are of clinical importance to older adults with aging-related conditions and advanced cancer undergoing palliative treatment. Funding: R01CA177592, U01CA233167, UG1CA189961. Clinical trial information: NCT02054741 .

Effects of a geriatric assessment (GA) intervention on symptomatic toxicity burden reported by older adults with advanced cancer during treatment.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 138-138
Author(s):  
Eva Culakova ◽  
Supriya Gupta Mohile ◽  
Huiwen Xu ◽  
Amita Patil ◽  
Sandy Plumb ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Usual Care ◽  
Advanced Cancer ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Random Effect ◽  
Patient Reported ◽  
Grade 3 ◽  
Cluster Randomized

138 Background: GA evaluates aging-related domains (e.g., function) known to be associated with cancer treatment toxicity. We found that providing a GA summary with management recommendations to oncologists reduces clinician-rated toxicity in older patients with advanced cancer receiving high risk treatment (presented at ASCO2020). Herein, we report on the effects of the GA intervention on symptomatic toxicities measured by Patient-Reported Outcomes Common Terminology Criteria for Adverse Events [PRO-CTCAE]. Methods: In the national cluster randomized clinical trial eligible patients (n=718) had age>70, advanced solid tumors or lymphoma, 1+ GA impairment, and were initiating a new treatment regimen with high risk of toxicity. Severity grade of 24 PRO-CTCAE items was collected on a 0-4 scale at enrollment, 4-6 weeks, 3, and 6 months. Of 24 items, 11 (e.g. fatigue, dyspnea) were classified as core (Reeve 2014). Baseline adjusted method (Basch 2016) was used to determine symptomatic toxicities: if the severity of any item increased after baseline to grade 2 or higher, the patient was classified as experiencing grade ≥2 event (similarly for grade ≥ 3 events). The effects of GA intervention on symptomatic toxicities were assessed using generalized linear mixed model (GLMM) with random effect for the practice cluster. Results: Mean age was 77 years (range 70-96); 43% female, 87% white; 34% had gastrointestinal and 25% had lung cancer; 27% received prior chemotherapy. 710 patients provided PRO-CTCAE data (366 usual care, 344 intervention), 85.6% reported grade ≥2 and 49.4% grade ≥3 events at baseline. After baseline, compared to usual care, patients in the GA intervention arm reported fewer grade ≥2 overall symptomatic toxicities (76.5% vs. 84.7%) and fewer core symptomatic toxicities (grade ≥2: 71.8% vs. 82.0%; grade ≥3: 46.2% vs. 53.6%). Specifically, less dyspnea and less fatigue was reported in GA-arm (Table). Conclusions: GA intervention resulted in fewer symptomatic toxicities as evaluated by PRO-CTCAE. Clinical trial information: NCT02054741 . [Table: see text]

Improving communication with older patients with cancer using geriatric assessment (GA): A University of Rochester NCI Community Oncology Research Program (NCORP) cluster randomized controlled trial (CRCT).

2018 ◽  
Vol 36 (18_suppl) ◽  
pp. LBA10003-LBA10003 ◽  
Author(s):  
Supriya Gupta Mohile ◽  
Ronald M. Epstein ◽  
Arti Hurria ◽  
Charles E. Heckler ◽  
Paul Duberstein ◽  
...  
Keyword(s):  
Usual Care ◽  
Older Patients ◽  
Controlled Trial ◽  
Intraclass Correlation ◽  
Clinic Visit ◽  
Adverse Outcomes ◽  
Oncology Research ◽  
Age Related ◽  
Cluster Randomized

LBA10003 Background: GA includes validated measures that assess age-related health domains (e.g., function, cognition) known to increase adverse outcomes. In this PCORI and NCI funded CRCT, we evaluated if providing a GA summary and recommendations for GA-guided interventions improves communication about age-related concerns for older patients (pts) with cancer. Methods: Pts aged ≥ 70 with advanced solid tumors or lymphoma and at least 1 impaired GA domain were enrolled. Oncology practices were randomized to intervention (oncologists received GA summary) or usual care (no summary provided). The primary outcomes were: 1) number of discussions about age-related concerns (the clinic visit after GA was audio-recorded and transcribed; 2 blinded coders evaluated quality of communication and plan for follow-up interventions) and 2) telephone surveys of patient satisfaction (modified Health Care Climate Questionnaire [HCCQ-age] scored 7-35). Outcomes were analyzed using linear mixed models with arm as the fixed effect, controlling for practice. Results: From 2014-17, 544 pts (295 in GA) were enrolled from 31 practices. There were no differences in demographics by arm (mean age 77 yrs; 49% female). More patients in usual care had impaired physical performance (96% vs 92%, p = 0.03) and social support (33% vs 25%, p = 0.05). In 530 evaluable pts, the overall mean number of discussions was 6.3 (SD: 4.0). The GA arm had 3.5 more discussions about age-related concerns (95%CI: 2.28-4.72, p = 10-6; intraclass correlation coefficient [ICC] = 0.24) compared to usual care; of these, in the GA arm, 2.0 more discussions on average had higher quality communication (95%CI: 1.20-2.69; p = 6x10-6) and 1.9 more led to interventions (95% CI: 1.14-2.73; p = 1.6x10-5). The GA arm had significantly more discussions for almost all GA domains. In 511 pts with HCCQ-age, the mean score was 22.9 (SD 4.5); the score was 1.12 points higher in the GA arm (95%CI: 0.23-2.03; p = .027; ICC = 0.02). Conclusions: Providing a GA summary to oncologists increases the number and quality of discussions about age-related concerns and improves pt satisfaction. Clinical trial information: NCT02107443.

Improving person-centered communication of goals, proxy, and advance directives in older patients with advanced cancer: Secondary analysis from a University of Rochester NCI Community Oncology Research Program (NCORP) cluster randomized controlled trial (CRCT).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11523-11523
Author(s):  
Marie Anne Flannery ◽  
Eva Culakova ◽  
Kah Poh Loh ◽  
Ronald M. Epstein ◽  
Charles Stewart Kamen ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Advance Directives ◽  
Advance Directive ◽  
Older Patients ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Community Based ◽  
Oncology Research ◽  
Patient Goals ◽  
Age Related

11523 Background: Quality person-centered care relies on effective communication between the clinical team and the patient/caregiver eliciting goals and discussing wishes. In a PCORI- and NCI-funded CRCT, we found that providing community-based oncologists with geriatric assessment-guided recommendations led to more and higher quality discussions of age-related issues for older patients with advanced cancer. In this secondary analysis, we assessed whether specific recommendations to oncologists to discuss patient goals, proxy and advance directives resulted in increased communication about these topics. Methods: Patients aged 70+ with advanced solid tumors or lymphoma and at least one impaired geriatric domain (e.g., function, cognition) were enrolled (URCC 13070; PI: Mohile). Oncology practices were randomized to the intervention (oncologists received recommendations to elicit goals and discuss wishes) or usual care. The clinic visit after the oncologist received recommendations was recorded and transcribed; two blinded coders evaluated the transcripts for discussion of the specific topic areas recommended in the intervention. Between arm differences were compared using generalized linear models controlling for practice cluster. Results: From 2014-17, 528 patients (284 intervention) provided transcripts from 31 practices (mean age = 77, range 70-96 years; 49% female; mixed cancer diagnoses). Topics related to patient goals, proxy and advance directive wishes were more often discussed in the intervention arm (goals of care preferences: 9 vs 2%, p = .02, treatment goals: 35 vs 20%. p = .04, elicit caregiver input: 28 vs 3%. p < .01, assess values and goals: 25 vs 7%, p = .07, health care proxy: 40 vs 1%, p = .004, advance directive: 25 vs 1%, p = .002). Conclusions: In this community-based study of older adults providing recommendations to oncologists to discuss specific topics resulted in increased person-centered discussions with patients and caregivers about goals, proxy and advance directive wishes. However, the content areas were discussed in less than half of all visits. Clinical trial information: NCT02107443.

Community and academic partnerships: Moving a new generation of clinical trials in NCI Community Oncology Research Program (NCORP) into community oncology practices.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 2551-2551
Author(s):  
Worta J. McCaskill-Stevens ◽  
Ann M. Geiger
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Care ◽  
Cost Of Care ◽  
Community Practice ◽  
Effective Strategies ◽  
Oncology Research ◽  
Research Activities ◽  
Community Oncology ◽  
Catchment Areas

2551 Background: NCORP is a model program that bridges academic and community oncology practices and research. Over the past decade, community cancer investigators have adopted new technology, encountered new treatment sequalae, and faced rising cost of care with its financial toxicity imposed upon individuals seeking care. Opportunities are abundant for community investigators to assess feasibility and uptake of research advances into community practice settings, yet these opportunities are met with the challenges of dynamic changes in types of organizations delivering cancer care and diversity of populations within their catchment areas. Little information is shared about how and to what extent the health environment influences this partnership and the implementation of a broad cancer research portfolio. Methods: This abstract reports on the continued interest and participation of community oncologists in research which is demonstrated by 987 practices with over 4000 investigators in NCORP. Since 2014, over 30,000 individuals enrolled in symptom management, screening, surveillance, quality of life, and treatment trials. An additional 4500 patients and clinicians have enrolled in care delivery studies. Results: NCORP has been central in evaluating the most effective strategies for investigators to effectively communicate to patients the science of genomically-driven trials. It has also provided ways of bringing the pediatric and AYA patients access to the most up-to-date treatment strategies and new therapies in their community. This creates the least disruption on family structure/dynamics, diminished traveling requirements/costs, and reduced the financial burden. NCORP promotes involvement of treating oncologists in research activities. This also improves care for patients not enrolled in clinical trials. Therefore, NCORP serves as a laboratory to determine the most effective strategies for co-management of cancer patients and survivors. Conclusions: Several questions however remain to be addressed using this clinical trial model. These include: how to continue to reduce disparities in cancer care and clinical trial participation; and, what are the best strategies for fostering implementation of cancer care models in community practice.

Characteristics of adult multiple myeloma patients receiving carfilzomib in a U.S. community oncology setting.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e19517-e19517
Author(s):  
Robert M. Rifkin ◽  
Rohan Medhekar ◽  
Khalid Mezzi ◽  
Kathleen Aguilar ◽  
Thomas Wilson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Real World ◽  
Older Patients ◽  
Patient Characteristics ◽  
Refractory Multiple Myeloma ◽  
Female Patients ◽  
Community Oncology ◽  
The Us ◽  
Baseline Characteristics

e19517 Background: Carfilzomib (K) is indicated for treatment of relapsed or refractory multiple myeloma (MM). We studied the characteristics of patients receiving K in the US Oncology Network’s (USON) EHR database. Methods: Patients ≥18 years who received a K-containing regimen between 11/01/2013-02/29/2016, were not in a clinical trial, and had ≥2 visits at a USON clinic were eligible. Baseline characteristics were compared between patients who received a K-based doublet, triplet or other regimen (monotherapy or >3 treatments). Results: Of the 718 patients who received a K-based regimen during the study period, 219 (30.5%) had doublet regimens, 287 (40.0%) received triplet regimens and 212 (29.5%) received other regimens; 494 (68.8%) received regimens with ≥3 therapies. Mean age was 69.7 and 64.7 years among patients on doublets and triplets, respectively. A higher proportion of female patients received doublets (53.0%) (Table). There were no differences in ISS stage or number of comorbidities across patients receiving doublets, triplets, or other regimens. Conclusions: In this real-world analysis of K-regimens, a majority of patients received triplet regimens. Older patients received doublet regimens more frequently. The influence of regimen on outcomes controlling for patient characteristics and prior treatments among MM patients receiving K-based regimens should be studied. [Table: see text]

Communication about comorbidities among 527 older patients with advanced cancer and their oncologists and caregivers: A multisite cluster-randomized controlled trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12040-12040
Author(s):  
Amber Kleckner ◽  
Nikesha Gilmore ◽  
Elizabeth Belcher ◽  
Allison Magnuson ◽  
Richard Francis Dunne ◽  
...  
Keyword(s):  
Cancer Treatment ◽  
Advanced Cancer ◽  
Older Patients ◽  
Controlled Trial ◽  
Random Effect ◽  
Clinic Visit ◽  
Care Physician ◽  
Older Americans ◽  
Cluster Randomized ◽  
Management Recommendations

12040 Background: Older patients with advanced cancer often have comorbidities that increase the risk of toxicity from neoplastic therapy but are not always considered in treatment planning. We assessed the utility of a geriatric assessment (GA) intervention to increase the number and quality of discussions about comorbidities among oncologists, older patients, and caregivers. Methods: This multi-site trial enrolled patients who were ≥70 years, had advanced solid tumors or lymphoma, had ≥1 GA impairment, and who were considering or receiving cancer treatment. All patients received the GA and completed an Older Americans Resources and Services Comorbidity survey, which evaluated 15 conditions and interference with activities (clinical impairment = ≥3 comorbidities or ≥1 highly interfering). Oncology practices were randomized to intervention (GA with a summary with management recommendations provided to oncologists) or usual care (GA only). The clinic visit after GA was audio-recorded, transcribed, and coded for GA topics including comorbidity. Generalized linear mixed models adjusting for site (random effect) were used to assess the effect of the intervention. Results: Patients (n=527 evaluable, 76.6±5.2 years, 49% female) and oncologists (n=131, 63 in intervention) were enrolled from 31 sites. In total, 94.5% of patients had ≥1 comorbidity with an average of 3.2±1.9; 64% were clinically impaired by comorbidity (p=0.76 between arms). The intervention arm had twice the number of conversations about comorbidities (1.02 vs. 0.52 conversations per patient, difference 0.50, 95% CI 0.18-0.81, p=0.004) and conversations were more likely to be initiated by the oncologist (p<0.001, Table). Moreover, among patients who had conversations about comorbidities, more patients in the intervention arm had discussions specifically addressing comorbidities (e.g., cancer treatment modification, communication with the primary care physician; 24.3% vs. 7.5%, p=0.003). Conclusions: Providing oncologists with a GA summary and recommendations encouraged them to engage in more discussions about their patients’ comorbidities with the goal of addressing interactions between comorbidities, cancer, and its treatments. Funds: PCORI CD4634, NCI UG1CA189961 Clinical trial information: NCT02107443 . [Table: see text]

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