Feasibility Randomised Control Trial of OptiMal: A Self-Management Intervention for Cancer Survivors
Round 1
Reviewer 1 Report
Comments and Suggestions for Authors
This is important research to improve the quality of life and self-care of cancer patients. It was very interesting, but improvements are needed in research methods and reporting of results.
In Table 1, I think a psychiatrist should be present during the ‘Mental Health and Cancer-related Cognitive Impairments’ sessions in week 4 rather than ‘Exercise and Physical Activity’ in week 3.
Is it correct?
In Table 1, I would like to advise adding information such as how the intervention was applied to the subjects and how many minutes each session lasted.
Remove the comma from line 114.
'Randomisation was carried out following completion of baseline questionnaires using a computer-generated randomization sequence [16].'
Random assignment after a preliminary survey may allow the researcher's bias to intervene in deciding which group to assign based on the responses reported by the subjects. Therefore, I would like to request to describe the random allocation method in detail.
Was allocation to treatment groups concealed?
Were participants blind to treatment assignment?
Were those delivering the treatment blind to treatment assignment?
Were outcome assessors blind to treatment assignment?
The selection criteria and exclusion criteria must state that only those who completed the follow-up survey after group assignment were targeted. Alternatively, all initially assigned subjects should be included in the analysis to avoid reporting bias.
Table 2 states that there is no difference in the characteristics of the two groups, but it would be better to report it more clearly. Please provide the statistic and p-value using chi-square or independent t-test.
In Table 3, please present statistical values instead of effect sizes. It was analyzed using a two-way analysis of variance. Differences between groups, differences over time, and interactions between time and groups should be shown in table 3.
There is confusion as to whether the quality of life variables that showed significant differences in Table 4 are the results of a two-way analysis of variance or a non-parametric test. It would be good to present statistics clearly and include quality of life in Table 3.
Comments on the Quality of English Language
Please correct the typo in the sentence.
Author Response
Dear Reviewer,
Many thanks for taking the time to review our article and for providing very helpful feedback to improve the standard of our paper. Please see attachment for our responses to your feedback.
Deirdre Connolly
Author Response File: 
Author Response.pdf
Reviewer 2 Report
Comments and Suggestions for Authors
The abstract briefly overviews the study's purpose, methods, results, and conclusion. However, here are some suggestions for improvement that could enhance clarity and comprehensiveness:
- Contextual Clarity: The abstract jumps into self-management without providing a brief context for readers unfamiliar with cancer survivorship issues. A single introductory sentence about the common post-treatment challenges could be beneficial.
- Intervention Description: While the name "OptiMal" is catchy, the abstract does not explain what the intervention involves. Even a brief phrase summarizing its components (e.g., "comprising weekly sessions on X, Y, and Z") would provide valuable insight into what the intervention entails.
- Diversity of Cancer Types: The majority of participants having breast cancer may skew the results. Mentioning how the findings might apply to other types of cancer or noting this as a limitation would be helpful.
Overall, the introduction is comprehensive and establishes a clear rationale for the research. It effectively conveys the significance of the problem, what is known from existing research, and the gap that the current study aims to fill. The current and relevant references provide a solid academic foundation for the study. It successfully conveys why OptiMal could be a promising intervention for cancer survivors and justifies the need for the study. Further improvement could involve refining the connection between the limitations of previous research and the current study's approach, possibly elucidating how OptiMal is uniquely positioned to address these gaps.
- The study used a randomized control trial (RCT), a robust design for testing the feasibility and examining the potential effectiveness of interventions like OptiMal. It was guided by the CONSORT extension guidelines for feasibility and pilot studies, which adds to its appropriateness.
While the methods are described to a certain extent, details on the randomization process, how adherence was encouraged and measured, and the specifics of the control group's "usual care" could be elaborated on for more precise understanding and reproducibility.
The procedure for recruiting patients is somewhat detailed, but additional clarity on how the randomization was concealed would improve this section. Additionally, more details on the procedure after recruitment, such as the specifics of the consent meeting and baseline measure collection, would be beneficial.
The flow of the results section could be improved by grouping related outcomes and using subheadings for different components of the study results, such as recruitment rates, retention rates, intervention adherence, and intervention outcomes compared to control.
The study set out to test the feasibility of the OptiMal intervention for individuals post-cancer treatment and found high adherence rates and low attrition, indicating feasibility.
Statistically significant improvements were reported in anxiety and quality of life for intervention participants, which supports the positive discussion regarding these aspects. Aspects that could be improved:
- The discussion could further address why some outcomes did not reach statistical significance and what this means for interpreting the results. It would be beneficial to explore the reasons behind the lack of significance and consider the study's statistical power.
- Although the study reports on feasibility, with high attendance and retention rates, the discussion would benefit from a deeper analysis of the demographics and characteristics of participants who completed the study versus those lost to follow-up.
- The text does not delve into the implications of the findings for the larger cancer survivor population, especially considering that the majority of study participants were women with breast cancer. There's an opportunity to improve the discussion by considering the generalizability of the results.
- The conclusion could benefit from a more critical reflection on the non-significant improvements in daily activities and what these findings imply for the efficacy of the intervention.
- The discussion should consider addressing the challenges faced by those with chronic conditions and how this subgroup might require tailored approaches within the OptiMal intervention.
Author Response
Dear Reviewer,
Many thanks for taking the time to review our article and for providing very helpful feedback to improve the standard of our paper. Please see attachment for our responses to your feedback.
Deirdre Connolly
Author Response File: Author Response.pdf
Round 2
Reviewer 1 Report
Comments and Suggestions for Authors
Overall, I think the revisions were done well according to the reviewer's opinion, and made it easy for readers of this journal to understand.
1. I believe that randomization should be done before pre-test data collection. I believe that the participant's tendencies and characteristics have been exposed through pre-test analysis. Why didn't the author randomize before collecting pre-test data?
2. From when to when is the data collection period for this study? Please describe the data collection period in the data collection procedure.
Comments on the Quality of English Language
Please correct any grammatical errors or typos in the sentences.
Author Response
Thank you for taking the time to review the changes we made to our paper. Please see attached document for details of our response to your second review
Author Response File: Author Response.pdf
Reviewer 2 Report
Comments and Suggestions for Authors
Thank you for your comprehensive responses to the feedback provided. It is evident from your detailed revisions that you have thoroughly addressed the concerns and suggestions raised. Adding context to the abstract, elaborating on the OptiMal intervention, and acknowledging the study's limitations regarding participant diversity significantly enhance the clarity and comprehensiveness of your paper.
Your efforts in expanding the introduction to connect previous research limitations with OptiMal's unique approach are commendable. This strengthens the rationale for your study and highlights its potential contribution to the field.
The enhancements to the methods section, including detailed descriptions of the randomization process, adherence encouragement, and control group specifics, significantly improve the paper's precision and reproducibility.
Furthermore, the added discussion on participant demographics and characteristics, as well as the limitations in generalizing the study's findings, demonstrates a thoughtful consideration of your study's scope and applicability.
The changes have addressed the initial concerns and added depth and robustness to the study, making it a valuable contribution to the field of cancer survivorship research.
Author Response
Many thanks for taking the time to review the revisions we made to our paper.
Author Response File: Author Response.pdf
