**3. Results**

From the search for relevant studies, the authors included a total of 22 studies conducted between 1998 and 2016. All of the articles included in the present study were published in peer‐ reviewed journals. The majority of the studies did not report using a theoretical framework as basis for the communication training program. Also, the majority of the studies did not provide exhaustive information about participants' demographics. When these data were available (7 studies out of 22), more participants were reported to be female, for a total of 275 females participating versus 212 total males participating. When data were available about the profes‐ sion of participants (12 studies out of 22), Participants included 658 physicians, 373 nurses, 29 research coordinators, and only 1 person described as a professional recruiter, although all par‐ ticipants in these training programs were responsible for recruiting patients for clinical trials. Half of the studies assessed the effectiveness of training by using quasi‐experimental designs; two of the remaining studies used survey as data collection methodology, and the other two studies used qualitative methodologies. Only 8 studies out of 22 reported whether the inter‐ vention was the first communication raining experience for participants, or not.

#### **3.1. Design of training programs**

With regard to the type of training developed and implemented, 18 studies out of the 22 analyzed employed a workshop format, while 1 training utilized coaching sections and peer‐ reviews [10]. Duration of the trainings varied across studies, ranging from a minimum of 3 hours, to a maximum of three days. Some trainings were spread over 2 days [29–31] or 3 days [46]. In the majority of the studies, participants selfselected into the training programs. Consistent with what has been observed in the literature on communication training in health care environments [32], the duration of the training programs seems to be an indicator of their effectiveness, with the longest trainings having the most positive outcomes. Information about the design of the trainings for each study is presented in **Table 1**.

#### **3.2. Content development and pedagogic tools**

The educational content of the trainings reviewed was varied, as was the source material used. Seventeen studies reported creating original content for their training, using source material that included the team's own original research, and collaborations with experts, such as oncologists, nurses, and clinical trials managers. One study explicitly reported the contributions of patients [30]. Another publication did not describe the process of developing the material, but reported that the training was done by instructors with previous experience in teaching communication skills to physicians. Similarly, the pedagogical tools adopted were varied. There was a general preference for the use of video materials, such as DVDs or videotaped scenarios, which were used in 10 training programs [29, 30, 33–40]. Other formats used included case studies, vignettes, instructional manuals, dummy referral letters, proto‐ cols, and didactic presentations. The majority of the trainings included role‐playing activi‐ ties, and/or review of real‐world discussions among recruiters and patients (whether actual or standardized patients). In many cases, checklists were used to standardize the observation

**Study** **Fallowfield et al.** [29]

**Jenkins et al.** [30]

**Fallowfield et al.** [39]

Experiment

No

Authors

Experiment

N/A

Authors, recruiters

Workshop, interactive

8 h, 2 days

Yes, randomization and

placebo

exercise, didactic

presentations, four DVD‐

based scenarios + handbook

Workshop, exercise and

3 day course

Yes

activities: small groups

critiques, SP\*, video reviews;

videotaped scenarios; case

histories, comprehensive

handbook; papers; annotated

bibliography

**Brown et al.** [37]

**Fallowfield et al.** [40]

Experiment, survey

No

Authors

and conversation

Survey and

Yes

Previous research with

Workshop, strategies

1 day

N/A

document, presentation of

strategies, video model of

ideal behavior, role‐played

(standardized patient)

Workshop, exercise and

3 days or 1.5

No

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

days

activities: small groups

critiques, SP, video reviews;

videotaped scenarios; case

histories, comprehensive

handbook; papers; annotated

bibliography

**Hietanen et al.** [41]

**Mann et al. JAN.** 

Interviews

Yes

Trial team

**2014**

Survey

No

Experts: oncologist‐

Workshop, lecture, role‐

1 day

Yes, randomization

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

played with real patients

APEX trial protocol and

N/A

Yes, randomization

181

research literature

psychotherapists

experts from different

fields

conversation

physicians, nurses trial

managers, and patients

Experiment

Yes

**Design**

**Control group**

**Content development**

Authors, physicians

and nurses

**Format educational material**

Workshop, five DVD‐based

8 h, 2 days

N/A

scenarios + handbook,

dummy referral letters

outlining patients' histories,

bibliography

**Duration**

**Sensitive words explained**


**3. Results**

180 Clinical Trials in Vulnerable Populations

**3.1. Design of training programs**

From the search for relevant studies, the authors included a total of 22 studies conducted between 1998 and 2016. All of the articles included in the present study were published in peer‐ reviewed journals. The majority of the studies did not report using a theoretical framework as basis for the communication training program. Also, the majority of the studies did not provide exhaustive information about participants' demographics. When these data were available (7 studies out of 22), more participants were reported to be female, for a total of 275 females participating versus 212 total males participating. When data were available about the profes‐ sion of participants (12 studies out of 22), Participants included 658 physicians, 373 nurses, 29 research coordinators, and only 1 person described as a professional recruiter, although all par‐ ticipants in these training programs were responsible for recruiting patients for clinical trials. Half of the studies assessed the effectiveness of training by using quasi‐experimental designs; two of the remaining studies used survey as data collection methodology, and the other two studies used qualitative methodologies. Only 8 studies out of 22 reported whether the inter‐

vention was the first communication raining experience for participants, or not.

about the design of the trainings for each study is presented in **Table 1**.

**3.2. Content development and pedagogic tools**

With regard to the type of training developed and implemented, 18 studies out of the 22 analyzed employed a workshop format, while 1 training utilized coaching sections and peer‐ reviews [10]. Duration of the trainings varied across studies, ranging from a minimum of 3 hours, to a maximum of three days. Some trainings were spread over 2 days [29–31] or 3 days [46]. In the majority of the studies, participants selfselected into the training programs. Consistent with what has been observed in the literature on communication training in health care environments [32], the duration of the training programs seems to be an indicator of their effectiveness, with the longest trainings having the most positive outcomes. Information

The educational content of the trainings reviewed was varied, as was the source material used. Seventeen studies reported creating original content for their training, using source material that included the team's own original research, and collaborations with experts, such as oncologists, nurses, and clinical trials managers. One study explicitly reported the contributions of patients [30]. Another publication did not describe the process of developing the material, but reported that the training was done by instructors with previous experience in teaching communication skills to physicians. Similarly, the pedagogical tools adopted were varied. There was a general preference for the use of video materials, such as DVDs or videotaped scenarios, which were used in 10 training programs [29, 30, 33–40]. Other formats used included case studies, vignettes, instructional manuals, dummy referral letters, proto‐ cols, and didactic presentations. The majority of the trainings included role‐playing activi‐ ties, and/or review of real‐world discussions among recruiters and patients (whether actual or standardized patients). In many cases, checklists were used to standardize the observation


**Study** **Wuensch et al.** 

Survey

No

Authors using

formative research

**EJoCC. 2011**

**Wells et al.** [47]

**Kimmick et al.** [38]

**Burnett et al.** [48]

**Table 1.**

Design and content of the training.

Experiment

No

Authors using

formative research

component

(literature review)

Experiment

Yes

N/A

Educational symposium,

N/A

No

lecture outline, videos,

emails, checklists, case

discussion seminar,

bibliography, slides

Workshop, reflective practice

1 day

Yes, randomization

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

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

183

Quasi‐experiment

Yes

Authors using

formative research

**Design**

**Control group**

**Content development**

**Format educational material**

Workshop, role‐play, pocket

17 h

card, feedback from experts

& colleagues

In‐person and online training

N/A

N/A

**Duration**

**Sensitive words explained**

Yes, randomization


**Study** **Paramasivan et al.** 

Content, thematic,

No

and conversation

analysis

**Larson et al.** [11]

**Cadman et al.** [33]

**Bernhard et al.** [35]

**Yap et al.** [36]

Observation and

Yes

Authors using

Workshop with didactic

N/A

Yes, randomization

presentation, slides, pocket

card, scientific article,

audiotaped examples

Didactic presentation and

N/A

N/A

educational material

materials from

previous projects

interviews with

patients

**Kendall et al.** [43]

**Jenkins et al.** [31]

**Fallowfield et al.** [44]

**Donovan et al.** [45]

**Mills et al. T 2014**

**Butow et al. HE 2015**

Experiment

Yes

Authors using

materials from

previous projects

analysis

Content and thematic

No

N/A

Mixed method

No

Authors based on

Workshop, document,

feedback, role‐playing

Documents, individual and

N/A

Yes, randomization

group discussions, role‐play

Workshop, video, role‐play,

7 h

N/A

individualized feedback

formative research

Experiment

No

Authors

Workshop

1 day

N/A

Yes, randomization

N/A

Experiment

No

Authors

Workshop with didactic

1.5 days

N/A

presentation, trial planning,

team‐building exercise, role‐

playing, open discussion

Quantitative: changes

Yes

Not produced by

authors. The source is

unspecified (US based)

in recruitment rates

Experiment

Yes

Authors based on the

Workshop with didactic

7 h

No

presentation and video,

strategies document,

feedback

available literature

Experiment

No

Experiment

No

Authors and

Workshop, lecture, vignettes,

3 h

N/A

182 Clinical Trials in Vulnerable Populations

administrative offices

NIMH—no info on the

Workshop, video, didactic

N/A

No

lecture

development

role‐played

**T. 2011**

**Design**

**Control group**

**Content development**

Previous research from

the team

**Format educational material**

Workshop, lecture (face to

N/A

face and teleconference)

**Duration**

**Sensitive words explained**

Yes, randomization

**Table 1.** Design and content of the training. and analysis of such discussions. **Table 1** reports the role and profession of the people who developed the content and materials used in the trainings, as well as the formats used in each training.

**Study Key information offered Scenarios Patient is** 

Stressed person communication demands; talking about innovativeness of the treatment; interacting with family members; communication difficulties when dealing with failing tests; communication for Phase II; study retention

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

(1) Introduction to trials, concept of randomization, difficulties associated with trials (use of different perspectives); (2) adjuvant treatment and uncertainty; (3) distressed patients, dealing with questions; (4) dealing with patients with preference for a specific study arm

Patient with stage II breast

Interviews considered

effective

cancer

N/A No Yes

N/A N/A N/A

N/A No Yes

N/A Yes Yes

N/A No No

different trials, tumor sites, and patient characteristics; communicating risks; checking

structure trial discussions; how to describe treatments available; process of randomization; checking for

knowledge acquisition; personal awareness

shared decision making; structuring consultations, risks & benefits; checking for understanding; providing clear & comprehensive information;

therapeutic options; informed consent; talking with relatives; psychosocial concerns

published on information about CT and informed

Lecture (face‐to‐face and teleconference); checking for

principles of ethical conduct; key elements of consent process; risks and benefits of participation; voluntary nature of research; purpose of research

research literature; checking for

avoiding coercion

Fallowfield et al. [40] Breaking bad news; discussing

consent

understanding

understanding

Hietanen et al. [41] Articles and checklist

Mann et al. JAN. 2014 APEX trial protocol and

Larson et al. [11] Personal experience;

Paramavisan et al.

T 2011

for understanding

understanding

Fallowfield et al. [29] Scenarios portraying

Jenkins et al. [30] Scenarios portraying how to

Fallowfield et al. [39] Skills development;

Brown et al. [37] Scenarios informing on

**suitable**

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

Yes Yes

No Yes

N/A Yes

Yes Yes

**Participation offered**

185

#### **3.3. Information conveyed**

Several areas of focus for the trainings were reported. Six studies [10, 13, 29, 38, 42, 46], reported training participants on the importance of assessing the eligibility of patients for the clinical trials. Authors reported assessing participants' performance on how to offer the opportunity to participate in clinical trials (with the exception of [40], which does not explic‐ itly mention it). Only six studies instructed participants how to address possible benefits and side effects associated with clinical trials participation [11, 29, 35, 37, 45, 46]. Generally, authors did not recommend different communication strategies for different phases of clinical trials. Seven trainings out of the 22 analyzed in this review instructed participants on how to check for patients' understanding of the information provided [10, 13, 29, 30, 34, 37, 42]. In this regard, Mann et al. [10] and Brown et al. [37] reported "summarizing" as a useful tech‐ nique to check for patients' understanding. Other topics specifically addressed by the training programs included how to explain the aims of clinical trials [10, 13, 29, 30, 39, 41], the impor‐ tance of informing patients about the voluntariness of their potential enrollment [10, 11, 29, 30, 33], or the importance of avoiding coercive behaviors and/or the importance of adopting a shared decision making process [34, 35, 37]. In some training, participants were instructed on strategies for clarifying key terms such as "randomization" and "placebo," which tend to be difficult for a large proportion of patients to understand or accept [10, 13, 30, 36, 39, 41, 42, 45, 46, 48]. Few studies explicitly addressed concerns and strategies to successfully deal with potential participants' struggle to manage uncertainty [29, 30, 36, 37, 42]. Ultimately, only 3 studies out of 22 specifically discussed the role that family members play in influencing patients' decisions on whether to enroll or not in clinical trials or provided training on how to better address family members' concerns [29, 30, 36, 40, 47]. A summary of the main informa‐ tion conveyed is shown in **Table 2**.

#### **3.4. Assessments**

Whether training programs had a concrete impact on the communication skills of the par‐ ticipants was assessed through several means. Consistent with the literature on trainings to improve physician‐patient communication [27, 49, 50], one of the most widely adopted strategies (13 studies out of 22) consisted of an evaluation of audio recorded interactions of participants in the training programs with either real‐world patients or standardized patients. Similarly, 16 studies reported having used self‐assessments, although specific mea‐ sures differed across studies. In one study [41], the self‐assessment consisted in a qualitative description of the experience participants in the training program had when interacting with patients. Only three studies did not explicitly report any assessment of the outcomes [11, 38, 43]. Although similar methodologies were used, the outcomes of the trainings tended to dif‐ fer significantly across studies. The strategies used to assess the communication trainings are shown in **Table 3**.


and analysis of such discussions. **Table 1** reports the role and profession of the people who developed the content and materials used in the trainings, as well as the formats used in each

Several areas of focus for the trainings were reported. Six studies [10, 13, 29, 38, 42, 46], reported training participants on the importance of assessing the eligibility of patients for the clinical trials. Authors reported assessing participants' performance on how to offer the opportunity to participate in clinical trials (with the exception of [40], which does not explic‐ itly mention it). Only six studies instructed participants how to address possible benefits and side effects associated with clinical trials participation [11, 29, 35, 37, 45, 46]. Generally, authors did not recommend different communication strategies for different phases of clinical trials. Seven trainings out of the 22 analyzed in this review instructed participants on how to check for patients' understanding of the information provided [10, 13, 29, 30, 34, 37, 42]. In this regard, Mann et al. [10] and Brown et al. [37] reported "summarizing" as a useful tech‐ nique to check for patients' understanding. Other topics specifically addressed by the training programs included how to explain the aims of clinical trials [10, 13, 29, 30, 39, 41], the impor‐ tance of informing patients about the voluntariness of their potential enrollment [10, 11, 29, 30, 33], or the importance of avoiding coercive behaviors and/or the importance of adopting a shared decision making process [34, 35, 37]. In some training, participants were instructed on strategies for clarifying key terms such as "randomization" and "placebo," which tend to be difficult for a large proportion of patients to understand or accept [10, 13, 30, 36, 39, 41, 42, 45, 46, 48]. Few studies explicitly addressed concerns and strategies to successfully deal with potential participants' struggle to manage uncertainty [29, 30, 36, 37, 42]. Ultimately, only 3 studies out of 22 specifically discussed the role that family members play in influencing patients' decisions on whether to enroll or not in clinical trials or provided training on how to better address family members' concerns [29, 30, 36, 40, 47]. A summary of the main informa‐

Whether training programs had a concrete impact on the communication skills of the par‐ ticipants was assessed through several means. Consistent with the literature on trainings to improve physician‐patient communication [27, 49, 50], one of the most widely adopted strategies (13 studies out of 22) consisted of an evaluation of audio recorded interactions of participants in the training programs with either real‐world patients or standardized patients. Similarly, 16 studies reported having used self‐assessments, although specific mea‐ sures differed across studies. In one study [41], the self‐assessment consisted in a qualitative description of the experience participants in the training program had when interacting with patients. Only three studies did not explicitly report any assessment of the outcomes [11, 38, 43]. Although similar methodologies were used, the outcomes of the trainings tended to dif‐ fer significantly across studies. The strategies used to assess the communication trainings are

training.

**3.3. Information conveyed**

184 Clinical Trials in Vulnerable Populations

tion conveyed is shown in **Table 2**.

**3.4. Assessments**

shown in **Table 3**.


**3.5. Improved outcomes**

**Table 2.** Information conveyed.

training participation are shown in **Table 3**.

Clinical trial communication training programs influenced several outcomes. In seven stud‐ ies, participants reported increased confidence in their ability to better interact with and educate patients. However, in terms of better communication of clinical trials, only a few studies reported strong effects [29, 30, 33, 36, 41], with only one article reporting modest but significant changes [39]. A study by Brown et al. [37] reported no significant improvement in participants' ability to provide clinical information, nor did they report differences in the way participants structured their consultations. However, the authors reported improve‐ ments in shared‐decision making behaviors, and in refraining from using coercive behaviors [37]. Fallowfield et al. [40] demonstrated improvements in participants' communication and information provision skills as a result of the training, even if communication about clinical trials specifically was not significantly affected by training. In one study [10], participants reported increased knowledge of trial design, and an improved ability to adhere to the study protocol after receiving the training. Mills et al. [13] observed that after the training partici‐ pants improved in their ability to address patients' preferences. Only three studies assessed and obtained improvements in accrual rates [38, 43, 47]. The positive changes associated with

**Study Key information offered Scenarios Patient is** 

framework; correctly sequence information; ensure clarity;

Butow et al. HE 2015 Shared decision making

Wuensch et al. EJoCC

2011

avoid coercion

Wells et al. [47] Barriers, beliefs, social norms,

Kimmick et al. [38] Importance of mental

trial enrollment

comorbidity

Burnett et al. [48] Importance of clinical trials;

barriers

Opening of discussion; disclosing risks and benefits; offering participation; clarifying meaning of randomization

myths of African Americans and Hispanics about clinical

status assessment; assess depression, cognition,

types of clinical trials; benefits; randomization; answer questions; provide screening recommendations, **suitable**

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

Yes No

N/A N/A

Breast cancer trials N/A Yes

Oncology clinical trials Yes Yes

Radiation therapy No No

Geriatric oncology clinical

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

Nursing oncology clinical

trials

trials

**Participation offered**

187


**Table 2.** Information conveyed.

**Study Key information offered Scenarios Patient is** 

Mental health, but authors suggest that the video can be used to improve informed consent in general; study presentation; risks & benefits; alternative treatments; confidentiality & patients' rights; voluntariness of

Children and their family

Breast cancer patients N/A N/A

N/A N/A N/A

Cancer teams in UK N/A Yes

Breast cancer teams N/A Yes (actual

N/A N/A Yes

N/A Yes Yes

recruitment)

participation

members

Cadman et al. [33] Communication skills (style,

186 Clinical Trials in Vulnerable Populations

building

Bernhard et al. [35] Shared decision making;

Yap et al. [36] Communication skills

Kendall et al. [43] Specifically tailored to the

Jenkins et al. [31] Team‐specific involvement in

Fallowfield et al. [44] Tailored to the needs of the

Donovan et al. [45] Tips for recruitment; case

Mills et al. T 2014 Importance of eliciting

use of plain language, body language, tone of voice, eye‐ contact); contextual elements (environment); relevant elements of informed consent; importance of relationship

sequential information disclosure; clarity; disclosing controversial information; avoiding coercive communication

(positive and negative examples); importance of considering emotional preparedness of patients & family members; metaphors to explain randomization;

stressed person

communication demands; literacy concerns

needs of the recruitment site

research; patients' attitudes; problematic trials; interpersonal communication with team members; planning strategies; identification of potential issues

site; trials planning; quality of patient sheet; interpersonal communication; time management

studies; informed consent process; risks/benefits; importance of randomization

and exploring treatments preferences; strategies to explain randomization; importance of balance of arms

in the patient sheet

**suitable**

No N/A

N/A Yes

**Participation offered**

#### **3.5. Improved outcomes**

Clinical trial communication training programs influenced several outcomes. In seven stud‐ ies, participants reported increased confidence in their ability to better interact with and educate patients. However, in terms of better communication of clinical trials, only a few studies reported strong effects [29, 30, 33, 36, 41], with only one article reporting modest but significant changes [39]. A study by Brown et al. [37] reported no significant improvement in participants' ability to provide clinical information, nor did they report differences in the way participants structured their consultations. However, the authors reported improve‐ ments in shared‐decision making behaviors, and in refraining from using coercive behaviors [37]. Fallowfield et al. [40] demonstrated improvements in participants' communication and information provision skills as a result of the training, even if communication about clinical trials specifically was not significantly affected by training. In one study [10], participants reported increased knowledge of trial design, and an improved ability to adhere to the study protocol after receiving the training. Mills et al. [13] observed that after the training partici‐ pants improved in their ability to address patients' preferences. Only three studies assessed and obtained improvements in accrual rates [38, 43, 47]. The positive changes associated with training participation are shown in **Table 3**.


**Study** Paramavisan et al.

No

No

N/A

T 2011

Larson et al. [11]

Cadman et al. [33]

Bernhard et al. [35]

Yap et al. [36] Kendall et al. [43]

Jenkins et al. [31]

Fallowfield et al. [44]

Donovan et al. [45]

Yes

Yes

No

No

No

 No

No but used role‐play

 No

No

Yes

No

No

No

No

No No

No No

No Yes

Accrual

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

N\* of patients approached;

professionals' involvement

with the trial; awareness;

confidence

Awareness of other members'

roles; confidence; facilitation

of the workshop; role‐play;

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

planning

Use of right documents;

completion of informed

consent; accrual

189

Yes

No

No

No

Yes, completed by

Adoption of a sequence

approach; eliciting questions;

clarifying concepts

patients

Yes

No

No

Yes

Yes

No

No

No

No

Yes

N/A

Yes

N/A

N/A

N/A

**Audio‐taped** 

**Patient simulator** 

**Participants generate** 

**Strategies/key points** 

**Subjective** 

**Outcomes considered**

**assessment/survey**

**document**

Yes (tips)

Yes (from

Confidence; addressing

patients' preferences/

concerns; knowledge of

informed consent elements

Enthusiasm and surprise

about the perceived

improvement

Knowledge of informed

consent elements;

communication; contextual

factors

Reduction of patients'

decisional conflict; patients'

involvement; reduction of

patients' anxiety

interviews)

**list of optimal points**

**assessment**

**assessment**


**Study**

**Audio‐taped** 

**Patient simulator** 

**Participants generate** 

**Strategies/key points** 

**Subjective** 

**Outcomes considered**

**assessment/survey**

**document**

**list of optimal points**

**assessment**

Yes

Yes

Yes

Yes

Self‐confidence;

communication of trial entry;

voluntariness; questions

188 Clinical Trials in Vulnerable Populations

asking; discussion of

symptom control; permit time

for consideration; discussion

of aims

Communication of trials;

use of key words; check

patient understanding;

self‐confidence

Quality of the course

material; expression of

empathy; communication

skills

**assessment**

Fallowfield et al. [29]

Jenkins et al. [30]

Fallowfield et al. [39]

Brown et al. [37]

Fallowfield et al. [40]

Hietanen et al. [41]

Mann et al. JAN 2014

 Yes

No

No

No

Yes

No but voice

Yes

No

No

No but description

Psychosocial reaction;

interviewing techniques;

patients' needs when

receiving info about CT

Protocol adherence;

knowledge of trial design;

acceptability of the training;

communication skills

of personal

experience

feedback

 Yes

Yes

No

No

Yes

Yes

Yes

No

Yes

Yes

Shared decision‐making

behavior; reduction of

coercive behaviors. Patients'

attitudes; Physicians'

behavior

Confidence; discussion of

clinical trials; communication

skills; self‐awareness;

improvement in the consent

process

 Yes

Yes

N/A

N/A

Yes

Yes

Yes

Yes

Yes

Yes

 Yes


**Table 3.** Assessment and improved outcomes. **4. Discussion**

This study presents a systematic review of published articles on trainings to improve commu

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

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

the recommendations provided by the literature on clinical trials accrual [

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

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

‐

191

‐

‐

‐

‐

‐

‐

‐

‐

5,

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

9, 54]. However, the
