Educational program on cancer cachexia for nurses: a pilot randomized controlled trial

ERCT Criteria Breakdown

• Level 1 Criteria

  • C

    Class-level RCT

    • Randomisation was performed at the individual nurse level within the same facilities rather than by class or school, with contamination explicitly acknowledged.
    • "Given the possibility that participants from the intervention and control groups were allocated within the same facility, the research information sheet clearly stated that participants should refrain from discussing the study content with others until the study had concluded."
    • Relevant Quotes: 1) "Participants were randomly assigned to the intervention and control groups in a 1:1 ratio." (p. 3) 2) "A third person who was not involved in the intervention created a random list on a computer (block size 4) and handled the central allocation." (p. 3) 3) "Given the possibility that participants from the intervention and control groups were allocated within the same facility, the research information sheet clearly stated that participants should refrain from discussing the study content with others until the study had concluded." (p. 3) 4) "Nevertheless, both groups were allocated within the same facility, so informal information sharing may have occurred. Contamination could not be fully prevented." (p. 13) Detailed Analysis: Criterion C requires randomisation at the class level or stronger (school level), unless the intervention is a one-to-one/personal tutoring intervention, in which case student-level randomisation is acceptable. In this study, individual nurses were randomly assigned to the intervention or control group, and participants from both arms were located within the same facilities. The intervention is an asynchronous e-learning program for professional development, not one-to-one tutoring, so the tutoring exception does not straightforwardly apply. Moreover, the authors themselves explicitly recognise the resulting contamination risk, stating that both groups were allocated within the same facility and that "Contamination could not be fully prevented," and they even recommend cluster randomisation for a future trial. Randomisation was therefore at the individual level with acknowledged contamination, not at the class or school level. Criterion C is not met because randomisation was conducted at the individual participant level within shared facilities, with contamination explicitly acknowledged, rather than at the class or school level.
  • E

    Exam-based Assessment

    • Outcomes were measured with researcher-developed tests and questionnaires, not widely recognised standardised exams.
    • "The basic knowledge test used in the previous study [17] and case-based questions were developed by the researchers (validated by the same expert panel)."
    • Relevant Quotes: 1) "The basic knowledge test used in the previous study [17] and case-based questions were developed by the researchers (validated by the same expert panel). The basic knowledge test consisted of eight items, with scores ranging from 0 to 100." (p. 5) 2) "We developed a Japanese version of the COM questionnaire with the permission of the original authors [22]. Two translators performed forward and backward translations." (p. 5) 3) "To assess each component of the Capability, Opportunity, Motivation (COM), Behavior (-B) model, the tests and questionnaires included four outcome measures: the COM questionnaire, the basic knowledge test, case-based questions, and daily practice on cancer cachexia." (p. 4) Detailed Analysis: Criterion E requires the use of a standardised, widely recognised exam-based assessment that was not created specifically for the study. All outcome measures in this study (the basic knowledge test, the two case-based questions, the COM questionnaire, and the daily-practice measure) were developed or adapted by the researchers and validated only by an internal expert panel. They are custom instruments specific to cancer cachexia nursing rather than nationally or internationally standardised exams. No state, national, or otherwise widely recognised standardised test was used. Criterion E is not met because the study relied on custom researcher-developed tests and questionnaires rather than a recognised standardised exam.
  • T

    Term Duration

    • Outcomes were measured only up to one month after the short intervention, far less than one full academic term.
    • "Data were collected at baseline, immediately after the intervention, and one month later."
    • Relevant Quotes: 1) "Data were collected at baseline, immediately after the intervention, and one month later." (Abstract, p. 1) 2) "The e-learning program took approximately 50 min to complete." (p. 2) 3) "4 weeks after T2, participants completed Post-test and Questionnaire 2 and the Final Questionnaire within 1 week (grace period: +2 weeks)." (Table 1, p. 3) 4) "The enrollment period was from December 11, 2023, to March 31, 2024. The data were collected from April 1 to June 30, 2024." (p. 3) Detailed Analysis: Criterion T requires that outcomes be measured at least one full academic term (approximately 3-4 months) after the intervention begins. Here the intervention itself was a roughly 50-minute e-learning program, and the measurement schedule ran from a pre-test (T1), through the e-learning and an immediate post-test (T2, about two weeks after T1), to a final post-test four weeks after T2 (T3). The longest follow-up from the intervention was therefore about one month. Although the overall data-collection window (April-June 2024) spans a few months, this reflects staggered enrolment of different participants, not term-long tracking of any individual. The one-month follow-up is well short of a full academic term. Criterion T is not met because outcomes were tracked only about one month after the intervention, which is shorter than one academic term.
  • D

    Documented Control Group

    • The control group's demographics, size, baseline scores, and business-as-usual condition are clearly documented.
    • "Table 2 shows the demographic characteristics of participants in the intervention and control groups among those who completed the study."
    • Relevant Quotes: 1) "The control group completed the same test and questionnaires." (Abstract, p. 1) 2) "Participants in the intervention group completed the pre-test and questionnaire, the e-learning program, post-test and questionnaire 1, post-test and questionnaire 2, and the final questionnaire. Participants in the control group completed the same assessments without the e-learning program." (pp. 3-4) 3) "Table 2 shows the demographic characteristics of participants in the intervention and control groups among those who completed the study... participants in the control group were older than those in the intervention group (control group: 37.3 +/- 7.01; intervention group: 31.7 +/- 6.73 years)." (p. 6) 4) Table 5 reports control-group baseline (T1) scores for case-based questions, the basic knowledge test, and each COM-B component. (p. 11) Detailed Analysis: Criterion D requires that the control group be well-documented, including demographic information, baseline performance, and the conditions it received. The paper provides a dedicated column for the control group in Table 2 (age, sex, years of experience, facility type, department, academic degree, certification, prior education), documents its size (n=16 allocated, n=7 completers), reports its baseline scores in Table 5, and states clearly that the control group received the same tests and questionnaires but not the e-learning program (business as usual). This gives a clear basis for comparison at baseline. Criterion D is met because the control group's characteristics, size, baseline scores, and condition are clearly documented.

• Level 2 Criteria

  • S

    School-level RCT

    • Randomisation was at the individual nurse level within facilities, not at the school/facility level.
    • "In a future trial, it may be necessary to consider whether individual randomization within the same facility is appropriate, or whether an alternative design such as cluster randomization at the facility or ward level would be more suitable."
    • Relevant Quotes: 1) "Participants were randomly assigned to the intervention and control groups in a 1:1 ratio." (p. 3) 2) "Given the possibility that participants from the intervention and control groups were allocated within the same facility..." (p. 3) 3) "In a future trial, it may be necessary to consider whether individual randomization within the same facility is appropriate, or whether an alternative design such as cluster randomization at the facility or ward level would be more suitable." (p. 13) Detailed Analysis: Criterion S requires randomisation at the school level, i.e. entire institutions or implementing units randomly assigned to conditions. Although 9 facilities took part, the unit of randomisation was the individual nurse, and participants from both arms were allocated within the same facilities. The authors explicitly note that facility- or ward-level cluster randomisation was not used and would need to be considered in a future trial. Criterion S is not met because randomisation occurred at the individual participant level rather than at the school/facility level.
  • I

    Independent Conduct

    • The same authors developed the intervention and also designed, ran, and analysed the study, with no independent evaluator.
    • "RS: Conceptualization, methodology, investigation, data curation, and writing of the original draft. NH: Conceptualization, methodology, writing - review and editing, and funding acquisition."
    • Relevant Quotes: 1) "We developed the Comprehensive Cancer Cachexia Assessment Tool [19]." (p. 2) 2) "We developed an e-learning program for nurses to gain a basic understanding of cancer cachexia and learn how to use the Comprehensive Cancer Cachexia Assessment Tool [19]." (p. 2) 3) "A third person who was not involved in the intervention created a random list on a computer (block size 4) and handled the central allocation." (p. 3) 4) "RS: Conceptualization, methodology, investigation, data curation, and writing of the original draft. NH: Conceptualization, methodology, writing - review and editing, and funding acquisition." (p. 13) Detailed Analysis: Criterion I requires that the study be conducted independently of those who designed the intervention. Here, the two authors developed both the Comprehensive Cancer Cachexia Assessment Tool and the e-learning program, and the same authors conducted the investigation, data curation, and analysis. The only element of independence is a third person who created the randomisation list and handled central allocation; this is limited to allocation and does not extend to independent conduct of the intervention, data collection, or analysis. There is no external evaluation team overseeing implementation or analysis. Criterion I is not met because the intervention designers also conducted and analysed the study, with independence limited to random allocation only.
  • Y

    Year Duration

    • Follow-up was only about one month, far short of a full academic year, and criterion T is not met.
    • "Data were collected at baseline, immediately after the intervention, and one month later."
    • Relevant Quotes: 1) "Data were collected at baseline, immediately after the intervention, and one month later." (Abstract, p. 1) 2) "4 weeks after T2, participants completed Post-test and Questionnaire 2 and the Final Questionnaire within 1 week (grace period: +2 weeks)." (Table 1, p. 3) Detailed Analysis: Criterion Y requires tracking of outcomes for at least 75% of a full academic year (roughly 9-10 months). The longest follow-up here was about one month after the intervention. In addition, criterion T (Term Duration) is not met, and per the standard, if T is not met then Y cannot be met. Criterion Y is not met because the study tracked outcomes for only about one month, and the weaker term-duration criterion T was also not met.
  • B

    Balanced Control Group

    • The extra resource given to the intervention group (the e-learning program) is itself the treatment variable being tested against a business-as-usual control.
    • "Participants in the control group completed the same assessments without the e-learning program."
    • Relevant Quotes: 1) "We recruited nurses to care for patients with cancer and randomly assigned them to an intervention or control group. The intervention group completed an e-learning program and tests and questionnaires... The control group completed the same test and questionnaires." (Abstract, p. 1) 2) "Participants in the intervention group completed the pre-test and questionnaire, the e-learning program, post-test and questionnaire 1, post-test and questionnaire 2, and the final questionnaire. Participants in the control group completed the same assessments without the e-learning program." (pp. 3-4) 3) "The e-learning program took approximately 50 min to complete." (p. 2) 4) "this study aimed to evaluate the feasibility and acceptability of this nursing education program." (p. 2) Detailed Analysis: Applying the criterion B decision tree: the intervention group received an additional resource that the control group did not, namely the roughly 50-minute e-learning program (both groups otherwise completed the identical tests and questionnaires). The next question is whether this additional resource is the treatment variable being tested. It is: the e-learning program is precisely the educational intervention whose feasibility and acceptability the study set out to evaluate. The control condition ("the same assessments without the e-learning program") represents the business-as-usual comparison required to isolate the effect of adding the program. Because the extra resource is integral to and is the explicit treatment being tested, a business-as-usual control is appropriate and does not violate the balance requirement. The only extra input beyond the program is about 50 minutes of learning time, which is modest and inseparable from the intervention itself. Criterion B is met because the additional resource (the e-learning program) is the explicit treatment variable being tested against a business-as-usual control that received identical assessments.

• Level 3 Criteria

  • R

    Reproduced

    • This is described as the first study of its kind and has no independent replication.
    • "This study was the first to examine the feasibility and acceptability of cancer cachexia education for nurses."
    • Relevant Quotes: 1) "This study was the first to examine the feasibility and acceptability of cancer cachexia education for nurses." (p. 8) 2) "Before evaluating the effectiveness of the program, the potential challenges associated with its implementation needed to be identified." (p. 2) Detailed Analysis: Criterion R requires independent replication of the study by a different research team, published in a peer-reviewed journal. The authors describe this as the first study of its kind, and it is a pilot/feasibility trial whose full effectiveness evaluation has not yet been conducted. No independent replication is reported in the paper, and an internet search (BMC/PubMed and general web) found no other authors reproducing this specific cancer-cachexia nursing e-learning trial; only the authors' own related survey and scoping-review work was identified. Criterion R is not met because the study is the first of its kind and has not been independently replicated.
  • A

    All-subject Exams

    • Only cancer-cachexia nursing knowledge was assessed, and criterion E (standardised exam) is not met, so A cannot be met.
    • "To assess each component of the Capability, Opportunity, Motivation (COM), Behavior (-B) model, the tests and questionnaires included four outcome measures: the COM questionnaire, the basic knowledge test, case-based questions, and daily practice on cancer cachexia."
    • Relevant Quotes: 1) "To assess each component of the Capability, Opportunity, Motivation (COM), Behavior (-B) model, the tests and questionnaires included four outcome measures: the COM questionnaire, the basic knowledge test, case-based questions, and daily practice on cancer cachexia." (p. 4) 2) "The basic knowledge test used in the previous study [17] and case-based questions were developed by the researchers." (p. 5) Detailed Analysis: Criterion A requires that impact be measured across all main subjects using standardised exam-based assessments, and it explicitly depends on criterion E. Criterion E is not met here because only custom researcher-developed instruments were used. Furthermore, all outcomes are confined to a single narrow domain (cancer cachexia knowledge and practice for nurses), not a range of core subjects. Both because E is not met and because only one specialised domain was assessed, criterion A fails. Criterion A is not met because criterion E is not satisfied and only a single specialised domain was assessed.
  • G

    Graduation Tracking

    • There was no tracking to graduation; follow-up was one month, and criterion Y is not met.
    • "Data were collected at baseline, immediately after the intervention, and one month later."
    • Relevant Quotes: 1) "Data were collected at baseline, immediately after the intervention, and one month later." (Abstract, p. 1) 2) "4 weeks after T2, participants completed Post-test and Questionnaire 2 and the Final Questionnaire." (Table 1, p. 3) Detailed Analysis: Criterion G requires following participants through to graduation to assess long-term impact. The participants here are working nurses, not students progressing to a graduation milestone, and follow-up ended about one month after the intervention with no long-term tracking. An internet search for subsequent papers by the same authors tracking this cohort found none, and no graduation milestone applies to practising nurses. In addition, criterion Y is not met, and per the standard, if Y is not met then G cannot be met. Criterion G is not met because there was no long-term or graduation tracking and criterion Y was also not met.
  • P

    Pre-Registered

    • The trial was registered on UMIN-CTR on 27 November 2023, before enrolment (11 December 2023) and data collection (April 2024) began.
    • "Trial registration UMIN Clinical Trials Registry (UMIN-CTR), UMIN000052812. Registered on 27 November 2023."
    • Relevant Quotes: 1) "Trial registration UMIN Clinical Trials Registry (UMIN-CTR), UMIN000052812. Registered on 27 November 2023." (p. 2) 2) "The enrollment period was from December 11, 2023, to March 31, 2024. The data were collected from April 1 to June 30, 2024." (p. 3) 3) "This study was reported in accordance with the CONSORT guidelines (Additional file 2)." (p. 3) Detailed Analysis: Criterion P requires the study protocol to be pre-registered before data collection began. The paper states the trial was registered on the UMIN Clinical Trials Registry (UMIN000052812) on 27 November 2023. The enrolment period began on 11 December 2023 and data collection ran from 1 April to 30 June 2024, both of which are after the registration date. The registry ID is a valid UMIN-CTR identifier and the reported dates are internally consistent, so registration in a recognised public registry clearly preceded the start of enrolment and data collection. Criterion P is met because the trial was pre-registered on UMIN-CTR on 27 November 2023, before enrolment and data collection began.