The effect of cooperative learning approach with concept maps on nursing students’ knowledge acquisition on symptom management in cancer patients: a randomized controlled trial

ERCT Criteria Breakdown

• Level 1 Criteria

  • C

    Class-level RCT

    • Students (not whole classes or schools) were randomized, so the unit of randomization was below the class level and risks contamination.
    • "Students who met the inclusion criteria were randomly assigned to the intervention and control groups using simple randomization based on computer-generated random numbers." (p. 5)
    • Relevant Quotes: 1) "This randomized controlled trial with a pretest-posttest design was planned to examine the effect of the cooperative learning approach using concept maps on nursing students' knowledge acquisition and self-directed learning regarding symptom management in cancer patients." (p. 4) 2) "Students who met the inclusion criteria were randomly assigned to the intervention and control groups using simple randomization based on computer-generated random numbers." (p. 5) 3) "To further ensure the integrity of the intervention and comparability between groups, the intervention and control sessions were conducted separately and at different times." (p. 7) Detailed Analysis: Criterion C requires randomization at the class level (or stronger), unless the intervention is explicitly one-to-one tutoring/personal teaching. The paper states that individual students were randomly assigned to intervention and control groups using computer-generated random numbers. It does not state that intact classes (or schools/sites) were randomized. The authors note scheduling and anti-contamination measures, but these do not change the unit of randomization. Because student-level randomization is below the class level and the intervention is not described as one-to-one tutoring, the ERCT class-level RCT requirement is not met. This criterion is not met because randomization was at the student level, not at the class (or school) level.
  • E

    Exam-based Assessment

    • The primary educational outcome used a researcher-developed knowledge test rather than a widely recognized standardized exam.
    • "This test developed by the researchers according to the literature was created in two stages (16,17)." (p. 5)
    • Relevant Quotes: 1) "The study data were collected using the "Personal Information Form", the "Knowledge Test on Symptom Management in Cancer Patients", and the "Self-Directed Learning Scale"." (p. 5) 2) "This test developed by the researchers according to the literature was created in two stages (16,17)." (p. 5) 3) "In the first stage, 20 questions were created by the researchers based on the expected course outcomes related to the oncological symptoms covered in the internal medicine nursing course and the resources used in the course." (p. 5) Detailed Analysis: Criterion E requires a standardized exam-based assessment (i.e., a widely recognized external exam, not created for this particular study). The paper’s primary knowledge outcome is measured by a "Knowledge Test on Symptom Management in Cancer Patients" that was created by the researchers, based on course outcomes, and then evaluated for content validity and reliability. While these psychometric steps support internal quality, the instrument is still a researcher-developed test rather than a standardized, externally administered exam used broadly beyond this study context. The Self-Directed Learning Scale is not an exam-based achievement measure and does not satisfy the exam-based requirement for academic outcomes. This criterion is not met because the study uses a researcher-developed knowledge test rather than a standardized exam.
  • T

    Term Duration

    • Outcomes were assessed after a short intervention with only a 4-week follow-up, and the stated study period spans far less than an academic term.
    • "To measure the retention of knowledge, the same test was administered again 4 weeks after the post-test." (p. 7)
    • Relevant Quotes: 1) "The research was carried out between 11.25.2024 and 01.03.2025 in the nursing department of the faculty of health sciences of a university." (p. 4) 2) "A three-session plan was implemented with the experimental group students." (p. 6) 3) "To measure the retention of knowledge, the same test was administered again 4 weeks after the post-test." (p. 7) Detailed Analysis: Criterion T requires that outcomes be measured at least one full academic term (typically about 3–4 months) after the intervention begins. The paper describes a three-session intervention and a follow-up assessment "4 weeks after the post-test." The reported overall study window is "between 11.25.2024 and 01.03.2025". Interpreting these as month.day.year dates (as written), this spans from November 25, 2024 to January 3, 2025 (about 5–6 weeks), which is shorter than a full academic term. The last described follow-up point is only four weeks after post-test, reinforcing the short time horizon. This criterion is not met because the study’s follow-up period is far shorter than a full academic term.
  • D

    Documented Control Group

    • The control condition is clearly described (standard instruction), and baseline demographic comparability between groups is documented.
    • "The control group students received standard instruction (four hours of theoretical training on symptom management in cancer patients)." (p. 7)
    • Relevant Quotes: 1) "The control group students received standard instruction (four hours of theoretical training on symptom management in cancer patients)." (p. 7) 2) "Students were not given any additional resources for preparation or practice." (p. 7) 3) "There was no statistically significant relationship between the experimental and control groups when the distribution of age (p=0.341), gender (p=0.063), marital status (p=0.240), history of chronic disease (p=1.000), and family history of oncological disease (p=0.667) was compared (Table 1)." (p. 8) Detailed Analysis: Criterion D requires a well-documented control group, including what the control group received and baseline information enabling comparison. The paper specifies the control condition as standard instruction with four hours of theoretical training and explicitly notes that control students were not given additional preparation/practice resources during the study. The paper also provides baseline demographic comparisons (Table 1 and its narrative) indicating no statistically significant differences between groups on several listed characteristics. This is sufficient to understand the control condition and baseline comparability. This criterion is met because the control condition and baseline group characteristics are clearly documented.

• Level 2 Criteria

  • S

    School-level RCT

    • Randomization occurred at the student level within one university program, not by random assignment of schools or sites.
    • "Students who met the inclusion criteria were randomly assigned to the intervention and control groups using simple randomization based on computer-generated random numbers." (p. 5)
    • Relevant Quotes: 1) "The research was carried out between 11.25.2024 and 01.03.2025 in the nursing department of the faculty of health sciences of a university." (p. 4) 2) "Students who met the inclusion criteria were randomly assigned to the intervention and control groups using simple randomization based on computer-generated random numbers." (p. 5) Detailed Analysis: Criterion S requires school-level (institution/site-level) randomization. The study was conducted within a single university department and explicitly states that students were randomized. There is no indication that multiple schools, sites, or equivalent institutions were randomized. This criterion is not met because randomization was not performed at the school (site) level.
  • I

    Independent Conduct

    • The study does not report an independent third-party evaluation; key study elements were developed and analyzed by the author team.
    • "Author’s contributions Conceptualization: B.B.K., Methodology: B.B.K, A.A., Validation: A.A. B.B.K., Formal analysis: A.A. B.B.K, Investigation: A.A., S.B., ..." (p. 14)
    • Relevant Quotes: 1) "This test developed by the researchers according to the literature was created in two stages (16,17)." (p. 5) 2) "Researchers created six concept maps based on the literature and course outcomes (16,17)." (p. 6) 3) "Author’s contributions Conceptualization: B.B.K., Methodology: B.B.K, A.A., Validation: A.A. B.B.K., Formal analysis: A.A. B.B.K, Investigation: A.A., S.B., Resources: A.A., S.B., Software: S.B., Data Curation: A.A. S.B, Writing - original draft: A.A., B.B.K, Writing - review & editing: A.A. B.B.K." (p. 14) Detailed Analysis: Criterion I requires evidence that the study was conducted independently from the intervention designers/authors (e.g., external evaluators, independent data collection/analysis teams). The paper describes that the researchers developed key study materials (the knowledge test and concept maps). The author contribution statement indicates the author team performed core study functions, including methodology, formal analysis, and investigation. The paper does not include a statement indicating that an independent third party conducted implementation, data collection, or analysis. This criterion is not met because independent conduct by a third party is not demonstrated.
  • Y

    Year Duration

    • The study duration and follow-up are far shorter than 75% of an academic year, and ERCT rules also imply Y is not met when T is not met.
    • "The research was carried out between 11.25.2024 and 01.03.2025 ..." (p. 4)
    • Relevant Quotes: 1) "The research was carried out between 11.25.2024 and 01.03.2025 in the nursing department of the faculty of health sciences of a university." (p. 4) 2) "To measure the retention of knowledge, the same test was administered again 4 weeks after the post-test." (p. 7) Detailed Analysis: Criterion Y requires outcomes measured at least 75% of an academic year after the intervention begins. The reported study period is only several weeks (late November 2024 to early January 2025), and the final outcome assessment described is a four-week follow-up after post-test. This is substantially shorter than an academic year. Additionally, ERCT rules specify that if criterion T is not met, then criterion Y is not met. Since T is not met for this paper, Y is also not met. This criterion is not met because the study does not track outcomes for a year-like duration (and T is not met).
  • B

    Balanced Control Group

    • The paper reports equal instructional session duration across groups, and the main resource difference (concept maps/cooperative structure) is the intervention being tested rather than an unmatched time or budget boost.
    • "The duration allocated for the educational sessions was equal across groups." (p. 7)
    • Relevant Quotes: 1) "A three-session plan was implemented with the experimental group students." (p. 6) 2) "Each group was given a concept map prepared under the relevant heading." (p. 7) 3) "In the first session, each group member was asked to make individual preparations within the topics and concept map." (p. 7) 4) "The control group students received standard instruction (four hours of theoretical training on symptom management in cancer patients)." (p. 7) 5) "Students were not given any additional resources for preparation or practice." (p. 7) 6) "The training content was standardized using a structured presentation, and the same topic content was provided to both the experimental and control groups." (p. 7) 7) "The duration allocated for the educational sessions was equal across groups." (p. 7) Detailed Analysis: Criterion B evaluates whether the intervention group received additional time/budget/resources not matched in the control group, unless those additional resources are explicitly integral to what is being tested. The paper explicitly states that "The duration allocated for the educational sessions was equal across groups" and that content was standardized, which supports time balance during scheduled sessions. The experimental group used concept maps and cooperative learning. The control group received standard instruction and was not given additional preparation/practice resources. The experimental group was asked to make individual preparations in the first session; this likely implies additional student effort outside the cooperative sessions. However, that preparation appears to be a core component of the cooperative learning approach as implemented (i.e., integral to the treatment definition), rather than an optional add-on like extra tutoring hours or extra funded support. The paper does not describe additional paid staffing, extra class hours, or additional budget exclusive to the intervention. This criterion is met because scheduled instructional time is explicitly equal across groups and the primary resource difference is integral to the pedagogical intervention being tested.

• Level 3 Criteria

  • R

    Reproduced

    • No independent replication by a different research team was found for this specific study/intervention as of the ERCT check date.
    • Relevant Quotes: (No relevant quotes about independent replication were found in the paper.) Detailed Analysis: Criterion R requires evidence that a different research team independently replicated this specific study (or a clearly equivalent intervention and evaluation) in a different context, published in a peer-reviewed journal. The paper itself does not describe being a replication, and it does not cite any external replication of this exact study. An internet search was conducted (including queries by DOI, title, and NCT ID) to identify independent replication studies by other authors, and no such peer- reviewed replication publications were found. This criterion is not met because independent replication evidence for this specific study was not identified.
  • A

    All-subject Exams

    • The study does not use standardized exams across all core subjects, and because E is not met, A is not met as well.
    • "The study data were collected using the "Personal Information Form", the "Knowledge Test on Symptom Management in Cancer Patients", and the "Self-Directed Learning Scale"." (p. 5)
    • Relevant Quotes: 1) "The study data were collected using the "Personal Information Form", the "Knowledge Test on Symptom Management in Cancer Patients", and the "Self-Directed Learning Scale"." (p. 5) 2) "This test developed by the researchers according to the literature was created in two stages (16,17)." (p. 5) Detailed Analysis: Criterion A requires standardized exam-based assessment across all main subjects, and ERCT rules specify that if criterion E is not met then criterion A is not met. The study’s assessments include a researcher- developed knowledge test focused on symptom management and a self-directed learning scale; these are not standardized exams across a broad set of core subjects. This criterion is not met because standardized all-subject exams are not used and criterion E is not met.
  • G

    Graduation Tracking

    • The study does not track participants until graduation, and because Y is not met, G is not met as well.
    • Relevant Quotes: 1) "To measure the retention of knowledge, the same test was administered again 4 weeks after the post-test." (p. 7) Detailed Analysis: Criterion G requires tracking participants until graduation from the relevant educational stage. The paper reports only post-test assessment and a single follow-up "4 weeks after the post-test," with no mention of graduation outcomes or long-term follow-up. Per ERCT rules, if criterion Y is not met then criterion G is not met. Y is not met for this study, so G cannot be met. An internet search was also conducted for follow-up publications by the same authors on this cohort (using the paper title, DOI, author names, and the NCT identifier), and no graduation-tracking follow-up papers were identified. This criterion is not met because there is no graduation tracking (and Y is not met).
  • P

    Pre-Registered

    • Trial registration information indicates the study was registered on ClinicalTrials.gov before the study start date.
    • "Study Start (Actual) November 15, 2024" (ClinicalTrials.gov record as mirrored by ICHGCP) and "First Submitted November 14, 2024" (ClinicalTrials.gov record as mirrored by ICHGCP)
    • Relevant Quotes: 1) "Clinical trial number: NCT06695702, date of the registration: November 11, 2024" (p. 2) 2) "Trial Registration The study was prospectively registered at ClinicalTrials.gov prior to participant recruitment. The registration number is NCT06695702." (p. 13) 3) "Study Start (Actual) November 15, 2024" (ClinicalTrials.gov record as mirrored by ICHGCP) 4) "First Submitted November 14, 2024" (ClinicalTrials.gov record as mirrored by ICHGCP) 5) "First Posted (Actual) November 19, 2024" (ClinicalTrials.gov record as mirrored by ICHGCP) Detailed Analysis: Criterion P requires that the protocol be pre-registered before the study begins (before data collection/participant recruitment). The paper provides a ClinicalTrials.gov identifier (NCT06695702) and explicitly states that registration was prospective and occurred prior to recruitment. It also provides a registration date (November 11, 2024). The ClinicalTrials.gov record (accessed via the ICHGCP mirror, which states it retrieves information from ClinicalTrials.gov) lists "First Submitted November 14, 2024" and "Study Start (Actual) November 15, 2024", indicating the record was submitted before the study start date. This criterion is met because registry dates indicate registration occurred before the recorded study start date.