Facilitation of Enrollment onto Cancer Clinical Trials Using a Novel Navigator-Assisted Program: A Cross-Sectional Study

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

From a biostats and clinical epidemiology point of view, here are some comments for the Authors

- the manuscript covers a neglected area in public health and CTN appears to be a very interesting solution for cancer pts seeking for clinical/experimental infos about their disease

- I'm a bit surprised that the rate of trial participation in Canada is 5%, despite the very high level of Canadian health system! In that sense, CTN is an encouraging idea!

- line 52 CTN was established in Canada in 2019, by which institution!? please, specify it

- line 54, reference lacking

- line 77 Navigators, please give more details about them

- line 115, I do suggest to use Fisher' exact test only

- table 1 and everywhere, continuous covariates have to be reported as median/IQR, the same for median follow-up

 

Author Response

Current Oncology Manuscript 3246122

Nov 9, 2024

 

Reviewer One :

From a biostats and clinical epidemiology point of view, here are some comments for the Authors

- the manuscript covers a neglected area in public health and CTN appears to be a very interesting solution for cancer pts seeking for clinical/experimental infos about their disease

- I'm a bit surprised that the rate of trial participation in Canada is 5%, despite the very high level of Canadian health system! In that sense, CTN is an encouraging idea!

1. - line 52 CTN was established in Canada in 2019, by which institution!? please, specify it

Response The following was added to line 54.

The CTN program was established in 2019 in collaboration with the Canadian Cancer Clinical Trials Network (3CTN). 

2. - line 54, reference lacking

Response

 

Reference added Line 55   : 28.    Hamm C, Cavallo-Medved D, Moudgil D, McGrath L, Huang J, Li Y, et al. Addressing the Barriers to Clinical Trials Accrual in Community Cancer Centres Using a National Clinical Trials Navigator:A Cross-Sectional Analysis. Cancer Control. 2022;29:10732748221130164.

 

3. - line 77 Navigators, please give more details about them

Response The following was added starting at line 83

The Clinical Trials Navigators require a university degree or are placement students in their Master’s or clinical trials management placement courses. They are required to have a proficiency in reading scientific literature as this is an understood need to interpret the clinicaltrials.gov website.  They undergo a comprehensive onboarding program led by team staff, and have weekly quality improvement sessions regarding their clinical trials searches.  Each navigator leads a maximum of three disease sites to allow development of expertise.

4. - line 115, I do suggest to use Fisher' exact test only

Response

Thank you. Pearson Chi square test was removed

5. - table 1 and everywhere table 1 and everywhere, continuous covariates have to be reported as median/IQR, the same for median follow-up

Response:

Table 1 : median reported ; Range reported for continuous covariates

Table 2: median and range reported

Table 3 : not applicable

              

Reviewer 2 Report

Comments and Suggestions for Authors

Increasing access to patients for clinical trials is a global issue - in this study a search engine is used to assess potential trials for patients resulting in an almost 4 fold increase in accrual compared to historical norms. The study is clearly presented and well referenced and written. Minor suggestions

1. in the methods section the tenses are mixed "is" and "was" - the section should be entirely in the past tense for consistency

2. it would help the reader if context of Windsor Hospital was provided - what is its hinterland, what is the average distance for patients to the hospital - these data would help others extrapolate the findings of the study to their hospitals.

3. the study was conducted during the pandemic - this is mentioned in the discussion but no data is provided - it would help to have a time graph of accrual in the paper to demonstrate this impact as would some reflection on what was done during this time 

4. no data is provided on ethnicity -given the concerns about the need for diversity in trials some reference to this issue and why it wasnt included would be of interest 

Author Response

Please see the uploaded response.  

 

Current oncology Manuscript  3246122
Nov 9, 2024

Reviewer 2 Responses
Comments and Suggestions for Authors
1. in the methods section the tenses are mixed "is" and "was" - the section should be entirely in the past tense for consistency
Response: Methods converted to past tense.
2. it would help the reader if context of Windsor Hospital was provided - what is its hinterland, what is the average distance for patients to the hospital - these data would help others extrapolate the findings of the study to their hospitals.
Response
The following was added to line 66.
The Windsor Cancer Program is located 200 kilometers from the closest cancer program, and 400 kilometers to the leading cancer program in the province.

3. the study was conducted during the pandemic - this is mentioned in the discussion but no data is provided - it would help to have a time graph of accrual in the paper to demonstrate this impact as would some reflection on what was done during this time 
Response : The following was added starting on line 187
The effect of the pandemic is demonstrated in Figure 2.  A dramatic drop in applicants to the program was demonstrated starting with the onset of the covid pandemic in the spring of 2020.  Recovery was delayed and required a restructuring effort to realize recovery.

Figure 2: Applicants to the CTN Program per month - figure added to manuscript.

 

4. no data is provided on ethnicity -given the concerns about the need for diversity in trials some reference to this issue and why it wasn’t included would be of interest 
The following was added at line 152
We have ethnicity data on 234 applicants where we identified the following: Caucasian 183 [78.2%], American Indian 1[0.4%], Middle Eastern 8 [3.4%}, Asian 18 [7.7%], Black/ African American 4 [1.7%], Latino/Spanish 3 [1.3%], Other (which included Indigenous) 15 [6.4%], Prefer not to answer 6 [2.6%]