Successes and lessons learned in database development for national multi-site cancer care delivery research trials: the Alliance for Clinical Trials in Oncology experience

Zahrieh, David; Hillman, Shauna L.; Tan, Angelina D.; Frank, Jennifer L.; Dockter, Travis; Meyers, Bobbi Jo; Cherevko, Cassie L.; Peil, Elizabeth S.; McCue, Shaylene; Kour, Oudom; Gunn, Heather J.; Neuman, Heather B.; Chang, George J.; Paskett, Electra D.; Mandrekar, Sumithra J.; Dueck, Amylou C.

doi:10.1186/s13063-022-06536-x

Table 1 The alliance NCORP CCDR portfolio

From: Successes and lessons learned in database development for national multi-site cancer care delivery research trials: the Alliance for Clinical Trials in Oncology experience

Alliance #	Title	CT.gov Identifier	Study Design	Multilevel Data Collection			Quantitative Data		Qualitative Data
Alliance #	Title	CT.gov Identifier	Study Design	Levels	BL	FWP	Yes/No	Mechanism	Yes/No	Mechanism
A191402CD	Testing decision aids to improve prostate cancer decisions for minority men	NCT03103321	2x2 factorial cluster randomized trial	Clinics	Yes	No	Yes	Paper	No	-
A191402CD		NCT03103321	2x2 factorial cluster randomized trial	Patients	Yes	Yes	Yes	Paper	No	-
A231601CD	Improving surgical care and outcomes in older cancer patients through implementation of an efficient presurgical toolkit (OPTI-Surg)	NCT03857620	Parallel arms, cluster randomized trial	Clinics	Yes	Yes	Yes	Paper	No	-
				Providers and non-providers	Yes	Yes	Yes	Paper	Yes	Clinic observation / interviews
				Patients	Yes	Yes	Yes	Paper	No	-
A231602CD	Assessing financial difficulty in patients with blood cancers	NCT03870633	Observational	Clinics	Yes	No	Yes	Paper	No	-
A231602CD		NCT03870633	Observational	Patients	Yes	No	Yes	Telephone survey	No	-
A231701CD	Increasing socioeconomically disadvantaged patients’ engagement in breast cancer surgery decision making through a shared decision-making intervention	NCT03766009	Stepped-wedge	Clinics	Yes	No	Yes	Paper	No	Fields notes from observations
				Surgeons	Yes	No	Yes	Paper	Yes	Interviews
				Patients	Yes	Yes	Yes	Paper and Qualtrics survey; audio-recordings of clinic consults	Yes	Interviews/Focus groups
A231901CD	Improving Patient-Centered Communication in Breast Cancer: A RCT of a Shared Decision Engagement System (ShaRES)	NCT04549571	Stepped-wedge, including patientlevel randomization within a wave	Clinics	Yes	No	Yes	Paper	No	-
				Clinicians^b	Yes	Yes	Yes	Paper	Yes	Interviews
				Patients	Yes	Yes	Yes	ePRO^a	Yes	Interviews

BL Baseline, FWP Follow-up occasions.
BL data collection can occur at the time of site-level activation (e.g. baseline clinic surveys) or at the time of patient enrollment (e.g. baseline patient surveys).
A “Provider” is someone who has licensed prescriptive authority and includes Medical Doctor/Doctor of Osteopathy (MD/DO), Physician’s Assistant (PA), and Nurse Practitioner (NP).
^aElectronic patient-reported outcome data capture system.
^bClinicians include the participating surgeons and their designees (providers such as physician assistants and nurse practitioners; and other professional disciplines such as registered nurses and social workers).

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