**4. Discussion**

**Study** Mills et al. T 2014

Butow et al. HE. 2014

Wuensch et al.

Yes

Yes

No

No

Yes

EJoCC. 2011

Wells et al. [47]

Kimmick et al. [38]

Burnett et al. [48]

**Table 3.**

Assessment and improved outcomes.

No

No

No

No

Yes

No

No

No

No

No No

No No

No

Yes

 Yes

Yes

No

No

Yes

Yes

No

No

No

No

Addressing patients'

treatments' preferences;

improvement in informed

190 Clinical Trials in Vulnerable Populations

consent process

Shared decision‐making; high

satisfaction

Acceptance of the training;

relevance of the training;

appreciation of the training

Accrual; knowledge; attitudes

Accrual; accrual per type of

treatment

Knowledge; attitudes;

confidence; format of the

workshop; atmosphere;

usefulness; and quality of the

workshop

**Audio‐taped** 

**Patient simulator** 

**Participants generate** 

**Strategies/key points** 

**Subjective** 

**Outcomes considered**

**assessment/survey**

**document**

**list of optimal points**

**assessment**

**assessment**

This study presents a systematic review of published articles on trainings to improve commu‐ nication about clinical trials with patients. From the review, it appeared that the majority of the trainings followed the format of a workshop, as also observed in a previous review [51]. The duration of the trainings ranged from 3 hours to 3 days. According to literature on communica‐ tion training programs for physicians (not specifically aimed at improving clinical trial commu‐ nication), the optimal length for a training workshop seems to be 3 days [32]. However, currently there are not enough data to confirm these results in a clinical trial communication context.

In the majority of the articles reviewed, the educational materials used in the trainings were developed through the collaborative efforts of several experts with diverse backgrounds, includ‐ ing oncologists, clinical trial coordinators, researchers, and nurses. Having an interdisciplinary team seems to be a common strategy for successfully developing trainings to improve clinical trial communication. In order to further enhance educational materials and messages' effective‐ ness, appeal, and clarity, it may be beneficial to include communication researchers in the team.

The pedagogical materials were quite varied across trainings; despite this, there seemed to be a preference for visual forms of communication such as videos and vignettes, and role‐playing [52, 53]. Many training programs used checklists in order to help both participants and educa‐ tors to assess the outcomes of recruiters‐patient interactions (both when the conversation was reproduced in videos, as well as during role‐playing). These checklists were described as useful educational tools by all the studies and should be included in future training protocols, even if specific details on the content of these checklists are only approximately reported in the articles. Trainings themselves focused on several topics. A portion of this information is consistent with the recommendations provided by the literature on clinical trials accrual [5, 9, 54]. However, the choice of topics differed across the trainings, and not all key areas were reported as having been covered. Research teams generally collected preliminary data to provide better targeted informa‐ tion; this strategy is consistent with recommendations from previous studies focusing on com‐ munication trainings for physicians [55, 56], which encouraged trainers to consider contextual factors and characteristics of the organizations in which participants operate. However, future programs should provide content that is consistent with research on the barriers faced by poten‐ tial participants in order to develop well‐design trainings that are geared toward effective patient education. A first step toward this goal would be establishing an agreement on the outcomes that should be obtained through communication trainings to improve clinical trial accrual. In addition, only few studies reported positive, significant changes in participants' recruiting skills, although all participants reported increased confidence and satisfaction with the training. This is in line with findings from Townsend et al. [51]. Unfortunately, the fact that outcomes differed by study hindered our ability to statistically analyze results from the entire body of literature.

The articles synthetized in this paper represent an important effort toward the improvement of patient education about participation in clinical trials and research studies, and potentially, an increase in accrual rates. However, despite having conducted an extensive literature search, only 22 studies were found as adequate to be included in this systematic review. In our opin‐ ion, this finding alone is sufficient to call for additional studies aimed at evaluating the efficacy of trainings for improving clinical trial communication and subsequently, patient satisfaction with the enrollment/consent process as well as improved accrual rates for clinical trials.

**References**

cct.2014.05.004

DOI: 10.1200/JCO.2007.14.8114

jan.12254

[1] Friedman DB, Kim SH, Tanner A, Bergeron CD, Foster C, General K. How are we communicating about clinical trials? An assessment of the content and readability of recruitment resources. Contemporary Clinical Trials. 2014;**38**:275‐283. DOI: 10.1016/j.

Training Programs for Improving Communication about Medical Research and Clinical Trials...

http://dx.doi.org/10.5772/intechopen.70188

193

[2] Quinn GP, McIntyre J, Gonzalez LE, Antonia TM, Antolino P, Wells KJ. Improving awareness of cancer clinical trials among Hispanic patients and families: Audience segmentation decisions for a media intervention. Journal of Health Communication.

[3] Langford A, Resnicow K, An L. Clinical trial awareness among racial/ethnic minorities in HINTS 2007: Sociodemographic, attitudinal, and knowledge correlates. Journal of

[4] Haddad RI, Chan ATC, Vermorken JB. Barriers to clinical trial recruitment in head and neck cancer. Oral Oncology. 2015;**51**:203‐211. DOI: 10.1016/j.oraloncology.2014.12.007 [5] Albrecht TL, Eggly SS, Gleason MEJ, Harper FWK, Foster TS, Peterson AM, Orom H, Penner LA, Ruckdeschel JC. Influence of clinical communication on patients' decision making on participation in clinical trials. Journal of Clinical Oncology. 2008;**26**:2666‐2673.

[6] Carter RE, Sonny SC, Brady KT. Practical considerations for estimating clinical trial accrual periods: Application to a multi‐center effectiveness study. BMC Medical research

[7] Kaplan CP, Nápoles AM, Dohan D, Hwang ES, Melisko M, Nickleach D, Quinn JA, Haas J. Clinical trial discussion, referral, and recruitment: Physician, patient, and system fac‐

[8] Foley JF, Moertel CG. Improving accrual into cancer clinical trials. Journal of Cancer

[9] Parreco LK, DeJoice RW, Massett HA, Padberg RM, Thakkar SS. Power of an effec‐ tive clinical conversation: Improving accrual onto clinical trials. Journal of Oncology

[10] Mann C, Delgado D, Horwood J. Evaluation of internal peer‐review to train nurses recruiting to a randomized controlled trial–Internal Peer‐review for Recruitment Training in Trials (InterPReTiT). Journal of Advanced Nursing. 2014;**70**:777‐790. DOI: 10.1111/

[11] Larson EL, Cohn EG, Meyer DD, Boden‐Albala B. Consent administrator train‐ ing to reduce disparities in research participation. Journal of Nursing Scholarship.

[12] Krieger JL, Palmer‐Wackerly A, Dailey PM, Krok‐Schoen JL, Schoenberg NE, Paskett ED. Comprehension of randomization and uncertainty in cancer clinical trials decision making

tors. Cancer Causes & Control. 2013;**24**:979‐988. DOI: 10.1007/s10552‐013‐0173‐5

Health Communication. 2010;**15**:92‐101. DOI: 10.1080/10810730.2010.525296

2013;**18**:1131‐1147. DOI: 10.1080/10810730.2013.768723

Methodology. 2005;**5**:1‐5. DOI: 10.1186/1471‐2288‐5‐11

Education. 1991;**6**:165‐173. DOI: 10.1080/08858199109528114

Practice. 2012;**8**:282‐286. DOI: 10.1200/JOP.2011.000478

2009;**41**:95‐103. DOI: 10.1111/j.1547‐5069.2009.01256.x

This study contributes to the emerging literature on clinical trial communication, and to the litera‐ ture addressing clinical trials planning processes. Despite its contributions, this systematic review presents certain limitations. Only peer‐reviewed studies were included; there is the possibility that other teams have conducted training programs to improve clinical trial communication and have disseminated findings in formats other than peer‐reviewed journals. Future reviews should search for such materials and include them in their analysis. In addition, only materials in English were included, but it is possible that studies have been published in other languages.
