The Effect of Oncology Nurse Navigation on Mental Health in Patients with Cancer in Taiwan: A Randomized Controlled Clinical Trial

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

-       This is an interesting article, which is clear and well-written overall. However, a few and important points needs improvements.

-       The statistical analysis could be described more schematically and more clearly. For instance, how did the authors assess the normal distribution of values? How did they express the descriptive statistics? Which type of t-test, when applicable? When chi-square or Fisher tests were used, since they have different conditions to be correctly applied? Etc. Please, extensively revise this subsection.

-       I cannot find a clear list of inclusion and exclusion criteria in the methods section.

-       It seems that most patients were affected with breast cancer? Was this a reflection of the inclusion criteria, which are not clear, as commented above? If yes, why specific types of cancer were chosen? Moreover, I think that the authors should list all types of cancers affecting the study participants, since the category “others” is anyway relevant numerically.

-       Accordingly, the definition of “stage” is unclear, since different types of cancer were included.

-       Table 1 – continuous variables: were all distributions normal? Moreover, the p-value should be used. If the distribution is not normal, as declared by the authors, then the descriptive statistics should use median and IQR.

-       Table 2: abbreviations of the columns are not all clear.

-       In figure 3, error/variations bars should be included. Moreover, at each time point, symbols indicating the statistical significance should be included. The graphical aspect could be also improved.  

-       In the discussion, a perspective section could be added, in order to discuss the potential application of this oncology nurse navigation on mental health in patients with cancer could be also applied. For instance, could it be applied even to oncological children and their families due to the recognition of the important role of nurses in pediatric oncology (e.g. PMID: 15125554; 33988484), even if there are still relevant diagnostic barriers that may compromise the survival in these countries, where the problem of the limited access to modern methods of tumor diagnostics and treatment is still present even in academic centers and not low-income countries of Asia (as discussed in: PMID: 36276064). Other perspective points could be included, in addition to the one suggested just above.

-       A conclusion section is missing. Please, add a short paragraph highlighting the novelty and/or practical impact of your research.

-       References to be expanded according to the new discussion points.

Comments on the Quality of English Language

see above

Author Response

Please see the attachment.

Author Response File: Author Response.docx

Reviewer 2 Report

Comments and Suggestions for Authors

This is a well written manuscript of a randomized controlled trial that investigated the effect of oncology nurse navigation (ONN) on the mental health of patients with cancer in Taiwan.

The title, abstract, and the body of the paper are excellently presented. The results show that ONN has statistically significant effect on anxiety and demoralization between usual care and the intervention groups.

I wonder if the intervals between the post-test and follow-up periods were too short from the baseline resulting in the nonsignificant findings within group. If so, this should be mentioned in the discussion and a suggestion be made that the periods be extended for more than three and six months respectively, to achieve possible significant outcomes within group.

In lines 386-387, correct the terms "mild-stage (0, I) or middle-stage diagnoses (II, III) to "early stage (0, 1)" or "intermediate stage (II, III)" respectively.

In line 407, correct the phrase "It is therefore makes sense..." to 'It therefore makes sense".

In line 419, I am not sure if there is a typo. Otherwise correct "Therefore, patient experience depends on the communication about and coordination, continuum, transition, and appropriateness..." to "Therefore, patient experience depends on the communication about the coordination, continuum, transition, and appropriateness..."

Finally, in line 428-429, delete the repetition "These results indicate the potential benefits of an ONN program for improving the mental health and patient experience of patients with cancer" to "These results indicate the potential benefits of an ONN program for improving the mental health and experience of patients with cancer."

Check carefully for other typos and grammar errors that may exist in the manuscript.

It was my pleasure being part of this review process.

Best of luck!

Comments on the Quality of English Language

The quality of English language is very good and requires minor corrections for typos and grammar.

Author Response

Please see the attachment

Author Response File: Author Response.docx

Reviewer 3 Report

Comments and Suggestions for Authors

Thank you for an interesting randomized controlled clinical trial about prevalence of mental health problems among patients with cancer and whether oncology nurse navigation improved their mental health outcomes and medical experience in northern Taiwan.

 

Comments.

 

1.       Consider clarifying the title to your purpose and clarify the context/country.

2.       Clarify the cancer type in the abstract and the manuscript (maybe in the title). The majority have breast cancer, but what do you mean with “others”?

3.       Would it be valuable to add the time (data collection) in the abstract? Participants were outpatients recruited at the cancer centre of a regional teaching hospital in northern Taiwan from January 2019 to July 2020.

4.       Consider revising the specific statistical analysis in the abstract and focus on the result and conclusion instead. Maybe you can write that you performed descriptive and analytical statistical analysis and later in the method-section have all the specific tests you performed.

5.       Please check if your keywords are Mesh. I am not sure that “cancer patient” is correct, consider adding a more person-centred word? Consider adding more words about your topic mental health.

6.       The introduction is well-written and interesting to read.

I think the section on line 75 about the knowledge gap and your rationale can be improved.

Consider clarifying your purpose and research question, and also add your hypothesis.

7.       2.1. The Research design included the similar text as in the end of the introduction, maybe revise and have the design in only one place.

8.       Page 3. You excluded patients who had been diagnosed with psychological problems prior to their cancer diagnosis and those who were receiving palliative or hospice care, how you controlled this before inclusion and in the screening procedure?

9.       Consider move the text in 2.2 “G*Power 103 version 3.1 and pilot study data were used to estimate the required sample size for our study [24]. 104 For this purpose, we used the Distress Thermometer (DT) indicator (α = 0.05; standard 105 deviation = 2.52; effect size = 0.21; navigation group: mean/n = 2.32/19; usual-care group: 106 mean/n = 3.4/15). The estimated minimum required sample size was 118 participants, and 107 the power for post hoc testing was 0.83. A final sample of 128 patients in the study would 108 be necessary to provide the required power of 0.80” to the statistical analysis section.

10.   I find it difficult to understand your intervention, can it be clarified and synthesized further? I also find it difficult to understand how Figure 1 should be interpreted and read in relation to your intervention, can it be clarified? Perhaps Figure 1 will be easier to understand if the flows in the figure are horizontal instead of being read from top to bottom.

11.   2.5. Instruments, do you mean Measurements or Questionnaires? Maybe moved under the data collection instead of intervention.

12.   I don’t understand the numbers in Figure 2. In allocation you have 61 and 76 patients, and you have dropouts in the follow up (died, lost of follow up), and in the analysis you have the same number as in the allocation? I think it would be valuable to clarify all sample sizes in all measurement points and be open about writing that there are external non-responses and the reason for each measurement point.

13.   3.1. Demographic and instrument can be revised according to the information in Figure 2, and only be presented in one place. You have the same information twice. Please clarify how you calculate “The completion rate was 85.9%” or write your response rate. I suggest that the response rate was changed during the study period (The reasons for loss to follow-up were that 14 patients died, three patients withdrew from the study, and one was not physically able to fill out the questionnaires).

14.   The Table 1 is nice to illustrate your sample, especially to generalizability to other countries/contexts of your findings. Household monthly income, can it be converted to an international income? It is Employment status= Yes, that the patients have an employment? Sick leave? I don’t understand the follow: religion, smoking, exercise, drinking, Areca (betel nut) use, life dependence- and the answer yes. What is “yes”? Please clarify. The same with comorbidities and yes, and what kind of comorbidities? Clarify other cancer diagnosis. It is the cancer stage related to classification of tumours.

15.   Not sure if the Variable list is part of the table 1, or is it a separate table?

16.   Results the presentation is a bit difficult to read, it is possible to make the content more visible in relation to your purpose and hypothesis.

17.   Discussion. Consider relating your results to the care context more and findings more.  

18.   Discussion. It would be of value to include references in relation to your discussion of strengths and limitation of your review and methodology, validity/reliability.  

19.   Any limitations regarding your chosen methodology, or data collection that might need to be discussed? Findings in relation to the context and generalizability to an international audience.

20.   Should future studies/directions/clinical implications be presented in a separate headings and the conclusion in a separate heading and be clarified.

Author Response

Please see the attachment.

Author Response File: Author Response.docx

Round 2

Reviewer 1 Report

Comments and Suggestions for Authors

- For chi-square test, the number of observations is important and, in this case, are relatively low. I think Fisher's test would be more appropriate. 

- Overall, the statistical description is dispersive: it can be shorter and more schematic. Moreover, it is not clear why explanations about the staging were included here. Moreover, statistical analysis does not correspond exactly to data analysis.

- The prevalence of breast cancer, even if the two study groups do not seem to significantly differ in the ratio breast cancer/others, should be commented in the discussion, also in terms of impact of the two nursing approaches, I mean, if there were different results according to these two cancer groups (breast cancer vs.others).

- Table 1: X2 and t7Z column should be removed. Only p-values coming from Fisher exact test should be displayed. Probably, table 1 should be splitted.

- In the discussion the perspective and diagnostic limitations in Asia, also related to the pediatric field, should be supported by specific references from Asia were this aspect are discussed, as previously suggested. I am not sure that the WHO GBD and national cancer institute references specifically discuss this aspects. More specific discussion and also examples could be helpful to enrich this section.

- Novelty and practical impact section should be included in the perspective section and the conclusion should be the final section of the paper. 

Comments on the Quality of English Language

See above

Author Response

Please see the attachment.

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

The authors have responded adequately to my comments from the initial review, and I believe that the current revised draft is a better version of the manuscript.

Best of luck!

Comments on the Quality of English Language

The quality of English Language is good and requires just a little correction.

Author Response

Thank you for your positive feedback on the quality of the English language in our manuscript. While we appreciate your kind words, we have also taken into account the extensive feedback from other reviewers and made significant revisions to improve the overall clarity, accuracy, and readability of our manuscript. These changes aim to address all comments comprehensively and enhance the presentation of our findings.

Thank you once again for your valuable feedback and for helping us improve our manuscript.

Reviewer 3 Report

Comments and Suggestions for Authors

The manuscript is clearer, and several parts have been improved that strengthen the scientific quality. I have some comments that remain even after the revision.

Comments.

1.       Consider clarifying Figure 1 or delete and add/highlight in the text. Perhaps Figure 1 will be easier to understand if the flows in the figure are horizontal instead of being read from top to bottom.

2.       Instruments and your Measurements/Questionnaires is your data collection. Consider clarifying the primary and secondary outcomes if they will be presented in the heading “Intervention”.  

3.       I don’t still understand the numbers in Figure 2. In allocation you have 61 and 76 patients, and you have dropouts in the follow up (died, loss of follow up), and in the analysis you have still the same number as in the allocation? I still think it would be valuable to clarify all sample sizes in all measurement points and be open about writing that there are external non-responses and the reason for each measurement point. It is not true that it is the same sample size through all the measuring points as the figure shows, is it?

4.       Table 1 still have a challenge to read (effect on generalizability). The yes/no without explanation is little bit confusing, and what kind of information is necessary if not clarify what you mean with yes/no (religion, smoking, exercise, drinking, Areca (betel nut) use, life dependence). The same with comorbidities and yes, and what kind of comorbidities? It is the cancer stage related to TNM-classification of tumours? If yes, please add this information.  

 

Author Response

Please see the attachment.

Author Response File: Author Response.pdf

Round 3

Reviewer 1 Report

Comments and Suggestions for Authors

No additional major comments

Comments on the Quality of English Language

see above. Editing is needed.

Reviewer 3 Report

Comments and Suggestions for Authors

Many thanks, and I think the manuscript is clearer after revision. Good luck with your research!