AOCNP Clinical Trials and Evidence-Based Oncology Practice 2

Question 1

Evidence-based practice (EBP) in oncology nursing requires integrating which three components?

Accepted Answer

Best research evidence, clinical expertise, and patient values/preferences

Answer

The Sackett model of EBP integrates three equally important elements: (1) best available research evidence (systematic reviews, RCTs, clinical guidelines), (2) clinician expertise and judgment, and (3) patient values, preferences, and individual circumstances. All three must be balanced in clinical decision-making.

Question 2

An umbrella trial design in oncology differs from a basket trial in that an umbrella trial:

Accepted Answer

Tests multiple targeted therapies within one cancer type based on molecular subtype

Answer

Umbrella trials test multiple targeted drugs within a single cancer histology, with patients assigned to treatment arms based on their tumor's molecular profile (e.g., NCI-MATCH, LUNG-MAP). This is the opposite of basket trials (one drug, multiple cancer types). Umbrella trials efficiently match patients to therapies without running separate trials.

Question 3

Statistical significance (p < 0.05) in an oncology trial means:

Accepted Answer

The probability that the observed result occurred by chance alone is less than 5%

Answer

A p-value <0.05 indicates that if the null hypothesis (no treatment difference) were true, the probability of observing results as extreme or more extreme is <5% — a conventional threshold for rejecting the null hypothesis. Statistical significance does NOT equate to clinical significance; effect size and clinical context must also be evaluated.

Question 4

The Data Safety Monitoring Board (DSMB) in a clinical trial has authority to:

Accepted Answer

Recommend early trial termination for benefit, harm, or futility based on interim analyses

Answer

The DSMB (or DSMB/IDMC) is an independent committee that reviews unblinded accumulating data at pre-specified interim analyses. It can recommend early stopping for overwhelming efficacy, unexpected harm, or futility (low probability of showing benefit if continued), protecting trial integrity and participant safety.

Question 5

Number needed to treat (NNT) in an oncology trial communicates which concept?

Accepted Answer

The number of patients who must receive the treatment for one additional patient to benefit compared to control

Answer

NNT is the reciprocal of the absolute risk reduction (NNT = 1/ARR). It represents the number of patients who need to be treated with the experimental therapy (versus control) to prevent one additional adverse event or achieve one additional positive outcome. Smaller NNT values indicate greater treatment efficiency.

AOCNP - Advanced Oncology Certified Nurse Practitioner Practice Test

AOCNP - Advanced Oncology Certified Nurse Practitioner Practice Test

AOCNP Clinical Trials and Evidence-Based Oncology Practice 2