Question 1: Does the NCI have a listing of CCDR-related studies from the existing Research Bases?
Question 2: Can one start out only doing core treatment/prevention and then expand into CCDR in subsequent years?
Question 3: How do we budget for CCDR research, not knowing what it may entail until there are protocols/guidelines?
Question 4: How much money can be budgeted for CCDR? Is it 10% or is it 300K or "other" that has been mentioned?
Question 5: Further guidelines on what is considered "enhanced capabilities and/or additional component sites" for CCDR funding of $300,000?
Question 6: For the CCDR budget, the guidelines state that the total cost budget should not exceed $300,000/year. I interpret this to mean that the "total cost" cannot exceed $300,000/year and that this limit includes direct costs and indirect costs. Please confirm this.
Question 7: The term "Cancer Care Delivery Research" – in previous NCORP conversations/documents was defined as non-CT research and so we are seeking clarification if that's so and points to the work that NCCCP was doing, or is this a combination of both CT and other cancer care delivery research? If so, the Cancer Center is unclear which of the CTs fall in this category. Can we get updated definition?
Question 8: Will there be a CCDR research base to develop CCDR protocols?
Question 9: Can one start out only doing core treatment/prevention and then expand into CCDR in subsequent years?
Question 10: Through what channels will CCDR studies be made available?
Question 11: What are the expectations with regard to Cancer Care Delivery Research? The RFA states that during the start-up and initial phase of NCORP, the expected relative balance in the level of effort between clinical trials and cancer care delivery research will be approximately 90% and 10%, respectively for a Research Base. What is the expectation for Community Sites and Minority/Underserved Sites?
Question 12: If the community site applicant already has an established relationship with one or more applicants for the research base, how important is it to outline the possible collaborative CCDR research in the application?
Question 13: RE: Key Personnel. For Section (D) we are planning on including our NCCCP Core Leaders as "Other Significant Contributors" vs. Key Persons. Is that OK? Or would you suggest they be listed as Key Persons?
Question 14: How do we budget for CCDR research, not knowing what it may entail until there are protocols/guidelines?
Question 15: How much money can be budgeted for CCDR? Is it 10% or is it 300K or "other" that has been mentioned?
Question 16: Regarding budget allocation for Community Sites. The RFA is not clear on the $250,000 - $300,000 and what it's to support…..the Clinical Trials budget or the Cancer Care Delivery budget? Or both? But it can't exceed $300,000 Total? And, can the $300,000 be dispersed among the components based on each components expertise?
Question 17: Please provide further guidelines on what is considered "enhanced capabilities and/or additional component sites" for CCDR funding of $300,000.
Question 18: We understand "total costs" but wanted confirmation that this grant also means that the F&A costs are included in the $300,000 cap for Cancer Care Delivery Research.
Question 19: Re: Budget - There will be 2 budgets (1 for CT – prime applicant's budget, and 1 for CCDR). We are unclear how both budgets are presented for the total project. How do we combine for a total bottom line?
Question 20: If we only select one site for CCDR, does that mean if a study comes up in that domain and we think some of the other components can carry out as well they will not be able to enroll/open it as they are not designated as a CCDR site?
Question 21: Table 5 & 6: Can we count accruals from non-CCOP Cancer Care Delivery Research? This would include research studies we feel meet the definition of Cancer Care Delivery funded either internally or by other sources.
Question 22: Table 5—can sites list 'non NCI Research Base' CCDR that they have participated in?
Question 23: Table 5: CCDR Capabilities: is this past/current only or future CCDR activities?
Question 24: How would we complete Table 5 which asks for annual accrual over previous 5 years to CCDR studies when we were not participating in any?
Question 25: What are the examples of NCI protocols that we have participated in that are considered CCDR?
Question 26: I have heard 2 different versions which of these we can count as CCDR? Will we be able to list participation in STAR, SELECT, P5, C70807—as prevention and as CCDR?
Question 27: SWOG S0702 A Prospective Observational Multicenter Cohort Study to Assess The Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment – would this be considered a CCDR study?
Question 28: Cancer Letter Nov. 15, 2013 described 'Master protocol" to rely on biomarkers in testing multiple lung cancer agents (S1400). I guess this study is pending. Would this be considered CCDR study?
Question 29: The precursor for COG-ACCL 1033 was AALL03N1: Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL. We had it open at our site from 04/14/2005 - 09/09/2011. I think that this should be added to the list of CCDR studies.
Question 30: Can the following trials be considered as CCDR? ECOG E2Z02 SOAPP (Symptom Outcomes and Practice Patterns): A Survey of Disease and Treatment-Related Symptoms in Patients with Invasive Cancer of the Breast, Prostate, Lung or Colon/Rectum; ECOG E2Z04 - Quality of Life in Younger Breast Cancer Survivors
Question 31: Would the following trials fall under the category of CCDR? CALGB 366901-Observational Cohort Study: Chemotherapy Decision and Outcomes in Women Age 65 or Older with Operable, Newly Diagnosed Breast Cancer; and GOG 225-Can Diet and Exercise Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival?
Question 32: Clinical trials from non-profit organizations: One of our components asked if the ASCO workload project would fit into this category?
Question 33: We are inquiring as to whether or not the following studies might also be considered as CCDR? ECOG: PACCT-1; MDACC 2006-0198: CAM use and Cancer; MDACC:2009-0288 POWER; and MDACC 01-06: Mindfulness Relaxation.
Question 34: We are a health system with two major components and over 30+ sub-component sites. How do we structure and complete Tables 5 & 6? More detailed instruction would be appreciated.
Question 35: Table 5: Genetics/Biorepositories: To what extent/capabilities are you looking for sites to perform this capacity as the CCDR location?
Question 36: In Table 5 NCORP Community Site Cancer Care Delivery Research Study (CCDR) Capabilities there is a row for insurance breakdown. You are asking for the insurance breakdown for each subcomponent site, not by each type of study, correct?
Question 37: I have a question about table 5—The table asks us to: "Indicate patient insurance coverage type and percentage: 1=Group, 2=Individual, 3=Medicaid, 4=Medicare, 5= Other public". This is listed right below: "Indicate average annual accrual over previous 5 calendar years to CCDR studies". Does the insurance question mean insurance for patients enrolled in CCDR studies? or insurance for all patients in area? I'm not sure what you are asking.
Question 38: Table 5 Community Site CCDR Capabilities: On item 2 of the table it asks for insurance coverage by component and a percentage. Is this referring to coverage of the catchment area, or of the prior 5 year's accruals?
Question 39: Table 5 – regarding the question about pharmacy: You are asking us to categorize: "1 = On-site pharmacy, 2 = Clinical trials pharmacy, 3 = Patient education". I do not understand the "patient education" category..... does this mean "dedicated" patient education staff? Many pharmacies and offices use regular physicians (oncologist), pharmacists, or nursing staff to do patient education regarding medications.... does this count?
Question 40: In Sub-Section D. Cancer Care Delivery Research Program (12 Pages, it says: NOTE: Information on the capabilities of the component(s) designated for participation in cancer care delivery research in genetic counseling, multidisciplinary care, care coordination/navigation processes supportive/palliative care and outreach programs for minority/underserved populations may be summarized in a table as described in the Resources section above. Is this table 5?
Question 41: Table 6: In Sub-Section D. Cancer Care Delivery Research Program (12 Pages) it says: NOTE: Information on the past experience of the component(s) designated for participation in cancer care delivery research may be summarized in a table as described in the Resources Section above. By this do you mean table 6?
Question 42: Am I correct in this statement? The instructions state that it is recognized for community sites the CCDR initiative may be a new initiation. Will clinical research protocols be provided by the research bases, as well as the expectation that community sites will develop and write their own research? If the sites have to write their own research, what is the expected percentage of research base vs. community site research expected, and what year will we be expected to do our own research?
Question 43: Can we report prior studies of the medical care costs of cancer treatment and survivorship that use only secondary data, such as electronic medical records data and health insurance claims, as Cancer Care Delivery Research?
Question 44: Would accruals for CCDR studies funded by the Department of Defense, the Center for Disease Control, and the NCI SEER Patterns of Care count towards our NCORP accruals to determine eligibility for the higher ($4,000) payment?
Question 45: In addition to clinical trials, we have observational CCDR studies that involve accrual (patient interviews, surveys, clinic visits) and studies that do not involve patient contact (ie, use only clinical and administrative data). Can accrual numbers in Tables 5 and 6 include all 3 (clinical trials, observation with patient contact, observation without patient contact)?
Question 46: We are working on our NCORP application and want to know how should we categorize the Patient Reported Outcome Symptom and Side Effect Study (PROSSES) that we participated in through the NCCCP? My thoughts are Cancer Care Delivery because of the method of surveying pts is being studied, coupled with Quality of Life and/or Patient Reported Outcomes? We categorize it as a "registry" study but that is not specific enough.
Question 47: Can research performed within the Community Networks Program Centers (CNPC) be considered CCDR?
Question 48: Would E1Z11: A Cohort Study to Evaluate Genetic Predictors for Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS) be considered CCDR?
Question 49: Are grantees expected to develop their own CCDR studies? Will CCDR studies be made available through the Research Bases/CTSU?
Question 50: The guidelines for CCDR budget indicate that year 1 funding will primarily be for evaluating and enhancing informatics and data collection/reporting and for training of staff. For years 2-5, guidelines indicate that the budget should provide for supporting participation in specific studies (including study coordination, data management, and scientific services). We assume this includes the time and effort necessary for determining which studies to participate in and feasibility/prep to research activities. The 300 K cap is a small amount of funding for studies that would involve significant data collection, which is a strength of our site, such as accrual of a large number of patients, or a study involving significant pulling and processing of clinical and administrative data (i.e., no patient contact). Should we assume that additional funds will be made available when this is the case?
Question 51: Is the up to 300k per year for CCDR also available in the period/year 1 or only the 250k-300k Infrastructure payment?
Question 52: Are any of the following studies CCDR trials:
ALLIANCE NCCTG GLNE 010- Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma
SWOG S1008 (CURVES)- Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention in Breast and Colorectal Cancer Survivors, Phase II
ECOG E1Z11 - A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)
Question 53: Will we be penalized for requesting more than 300,000 (such as 400,000) for CCDR budget. Our ability to assist the research bases may be compromised due to lack of funding.
Question 54: Could you please provide clarification on Table 5: Patient Insurance Coverage? What is meant by Other Public? Examples of insurance types which would fall into this category?
Would it be acceptable to report Group and Individual insurance coverage categories together at this time?