Literature Review On Clinical Cancer Trials For Yoga

Factors Influencing Underrepresented Populations Recruitment of Clinical Cancer Trials for Yoga

Yoga is a commonly used complementary and alternative medicine (CAM) therapies among cancer patients, especially within breast cancer patients. However, the characteristics of breast cancer yoga user are predominantly white and those with lower body mass index (BMI) and higher education levels (Desai et al., 2010). Non-white, those with higher BMI and lower education are underrepresented in yoga for cancer studies. This literature review was conducted to explore factors influencing underrepresented populations recruitment of clinical cancer trials for yoga.

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It appears that there is only a small percentage of minority populations to participate in clinical trials (Desai et al. 2010). In fact, this seems to be due to a lack of recruitment of non-white (minority) participation in clinical trials, due to factors such as: a lack of trust in research, unmet transportation needs, the negative connotation of clinical trials and a lack awareness of opportunities for participation. Durant, Wenzel, Scarinci, Paterniti, Fouad, Hurd, and Martin (2014) assessed the perspectives of cancer center clinical and research personnel (principal investigators, research staff, referring clinicians, and cancer center leaders) on the barriers and facilitators to minority recruitment. Interviews concluded that some barriers (distrust in research, unmet transportation needs, and the negative connotation of clinical trials) and facilitators (e.g. increasing awareness of opportunities for participation) were highly mentioned in all four groups. The interviewees perceive that there was apprehensions for racial and ethnic minorities to participate in clinical trials because of “distrust” based on historical research abuse, as well as minority population’s experiences with discrimination at interviewees respective sites. Other barriers for minority recruitment were lack of insurance and language discordance with providers, which make providers less likely to offer opportunities to participate in clinical trials. Additionally, interviewees expressed that there was a need to form partnerships with minority communities and gain their trust, to enhance minority recruitment. Afterward, to gain retention of potential participants for clinical trials, facilitators need to accommodate to the minorities cultural needs, stated desires, and stated biases. As well as addressing more practical needs such as transportation or lodging. Interviewees mentioned that internal referrals such as talking and educating patients in cancer centers would increase potential minority recruitment, however, the benefits to this approach may be limited by the small number of minority patients that have access to said cancer sites. Establishing relationships with individual, external physicians that have large minority client bases would improve minority recruitment. Therefore, according to Durant et al. (2014) factors influencing a lack of minority recruitment consist of: distrust in research, unmet transportation needs, negative connotation of clinical trials and a lack of awareness of opportunity for participation.

Specifically within the minority population, Rivers, August, Sehovic, Green, and Quinn (2013) found that African Americans (AAs) were less willing to participate in clinical trials, compared to their white counterparts. Factors that influence AA recruitment in clinical trials were explored. Results showed that, similarly to the previously mentioned research of Durant et al. (2014): AAs generally have negative connotation towards clinical trials; and AAs were more likely to participate in clinical trials if they trusted the people recommending the clinical trial (physicians, researcher, friend, or relative). In addition to these factors, the results showed that there AAs had a lack of knowledge regarding clinical trials, specifically because AA patients were not aware or informed of ongoing clinical cancer trials. Therefore, the recruitment of AA’s relies on informing and educating patients on the components of clinical trials. Another factor that limits AA recruitment is faith; some AAs believed that the outcome of their diseases progression were determined by God, and they had no control of it. Hence, with the previously mentioned factors of minority recruitment of Durant et al. (2014), specifically within AAs, a lack of knowledge of clinical trials and the influence of faith in participation, factor into the enrollment of minority recruitment into clinical trials.

To overcome some of the factors influencing minority recruitment Middleton, Lopez, Moonaz, Tataw-Ayuketah, Ward, and Wallen (2017) conducted a research yoga protocol that was design to accommodate these factors within arthritis patients. The cultural infrastructure of this study design consisted of a multicultural research team, translators, and bilingual materials and classes. In addition, the researchers decorated the protocol location with minorities doing yoga and decided to decrease what might be deemed as ‘spiritual’ aspects of yoga, during the creation of the protocol design. As a result, 93% of the participants recruited were female, the majority of participants were Hispanic (70%) or Black/African American (17%), and 69% were Spanish speaking. In journal entries and interviews, Most of the participants were satisfied with the yoga classes (94%), agree that yoga classes should be bilingual (93%), and would recommend yoga classes to friends with arthritis (94%). Half of the participants were more comfortable taking yoga classes from teachers with diverse racial/ethnic backgrounds (58%), and with others who have arthritis (62%). Thus Middleton et al. (2017) demonstrate that tailoring the recruitment process protocol to meet the cultural and language barriers, will increase recruitment of minority populations. However, because this yoga study was conducted for patients with arthritis, we cannot know if recruitment of minorities will increase recruitment for cancer patients.

In the same fashion, Dignan, Evans, Kratt, Pollack, Pisu, Smith, Prayor-Patterson, Houston, Watson, Hullett, Martin (2011) altered the recruitment process of minority populations as well as took into consideration other factors, such as access to transportation and lower socioeconomic status. Medically underserved and minority population cancer survivors, in public hospital that provided essential health services to underinsured and the uninsured living in metropolitan county was the population. Recruitment, into a Survivor Education and Evaluation (SURE) project, was done face-to-face, with a team that had similar racial characteristics. Not to mention they were under the supervision and with the cooperation and support of the clinical staff. Transportation was also provided to participants as needed. Of the patients that were approached, eligible, and consented, only 37.5% participated in the study. Participants that were recruited, were mostly African American (79.3%), female (65.7%), and 79.3% had a lower education (at least a high school diploma or less). During the screening process, eligibility barriers for potential participants included access to a working telephone, schedule conflictions, and a caregiver role. Lastly noted, the largest demographic loss throughout this study was among males (32.3%). Therefore, Dignan et al. (2011) states that recruitment of lower socioeconomic and lower educated minority populations in metropolitan areas can be obtained by providing transportation, working with venues clinical staff and conducting face-to-face recruitment. However, because this study was conducted for a Survivor Education and Evaluation (SURE) project, we cannot know if recruitment of lower socioeconomic and lower educated minorities for yoga will increase recruitment.

Equally important, we must acknowledge that the majority of patients that participate in yoga cancer clinical trials are females (Desai et al., 2010). There is a limited amount of research done on these factors, however one study conducted by Bock, Thind, Dunsiger, Fava, Jennings, Becker, Marcus, Rosen, and Sillice examined the characteristics of participants enrolling in randomized control trial (RCT) testing yoga as a complementary treatment paired with cognitive behavioral therapy (CBT) for smoking cessation. The demographics of willing and eligible participants consisted of 227 participants (101 males; 126 females). Of the ineligible potential participants, 54.8% were female. The results showed that both males and females were equally interested in yoga as a CAM therapy for smoking cessation. When examining differences by sex, females also had significantly higher expectations (p <.001) for yoga compared to male. Thus according to Bock et al. (2017), females participate in yoga as a CAM therapy because they have higher expectations of yoga. However, because this study was conducted for smoking cessation, we cannot know if higher expectations for yoga outcomes in female participate is due higher expectations for outcomes within cancer patients.

Lastly, based on the existing research, cancer patients who had a BMI <25 were more likely to have used yoga after their cancer diagnosis (Desai et al. 2010). Paxton, Phillips, Jones, Chang, Taylor, Courneya, and Pierce (2012) examined the association between physical activity and body mass index by race/ethnicity in a sample of breast cancer survivors. Results showed that African Americans also had the highest BMIs (p < .01) compared to their other ethnic counterparts. African American (45%) and Asian American (42%) survivors had greater proportions of obesity than white (25%) and Hispanics (32%) survivors (p < .05). White (52%) and Asian American (48%) survivors were more active and met physical activity guidelines in higher proportions than Hispanic (39%) and African Americans (32%) survivors ( all p < .01). Thus according to Paxton et al. (2012) minority populations, specifically African American survivors (p < .05), were less likely to meet physical activity guidelines and more likely to be obese than their other ethnic counterparts. This correlated with the previous reviews of literature explaining the reasoning for the lack of minority recruitment.  However, because this breast cancer study did not include yoga, we cannot know if a higher BMI of minority populations is associated to a lack of recruitment for yoga.

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It appears that underrepresented populations, specifically minorities, lack representation in clinical trials because of negative beliefs and attitudes of clinical trials. Also a lack of knowledge and opportunities of clinical trials, caused by a lack of awareness for opportunities to participate, due to socioeconomic and language barriers. Males were also shown to lack representation within yoga clinical trials because they had lower expectations of yoga outcomes. Additionally, a correlation between a higher BMIs and minorities was evident. All in all, these barriers to minority, lower educations, lower socioeconomical, and non-female patients can be broken by: educating the underrepresented populations; cancer clinical and research personal gaining cultural competence, socioeconomic and ethnical awareness, and having the willingness to alter recruitment and research design protocols to meet minorities cultural needs, may increase recruitment into yoga related cancer clinical trials. Caution must be advised, though; Desai et al’s and Paxton et al.’s studies were cross-sectional study, River et al.’s (2013) study was a systematic review, Bock et al.’s (2017) study used phone interviews for recruitment, Dignan et al.’s (2014), and Durant et al.’s (2014) studies were conducted using qualitative interviews.  While Middleton et al.’s (2017) study also used qualitative surveys, journals, and face-to-face interviews it was conducted with an arthritis population. Future studies should replicate these findings for yoga with different populations.

References

• Bock, B. C., Thind, H., Dunsiger, S., Fava, J. L., Jennings, E., Becker, B. M., … Sillice, M. A. (2017). Who Enrolls in a Quit Smoking Program with Yoga Therapy? American Journal of Health Behavior, 41(6), 740–749. https://doi.org/10.5993/AJHB.41.6.8
• Desai, K., Bowman, M. A., Galantino, M. Lou, Hughes-Halbert, C., Vapiwala, N., DeMichele, A., & Mao, J. J. (2010). Predictors of yoga use among patients with breast cancer. EXPLORE, 6(6), 359–363. https://doi.org/10.1016/J.EXPLORE.2010.08.002
• Dignan, M., Evans, M., Kratt, P., Pollack, L. A., Pisu, M., Smith, J. L., … Martin, M. Y. (2011). Recruitment of Low Income, Predominantly Minority Cancer Survivors to a Randomized Trial of the I Can Cope Cancer Education Program. Journal of Health Care for the Poor and Underserved, 22(3), 912–924. https://doi.org/10.1353/hpu.2011.0069
• Durant, R. W., Wenzel, J. A., Scarinci, I. C., Paterniti, D. A., Fouad, M. N., Hurd, T. C., & Martin, M. Y. (2014). Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: Enhancing minority participation in clinical trials (EMPaCT). Cancer, 120, 1097–1105. https://doi.org/10.1002/cncr.28574
• Middleton, K. R., Magaña López, M., Haaz Moonaz, S., Tataw-Ayuketah, G., Ward, M. M., & Wallen, G. R. (2017). A qualitative approach exploring the acceptability of yoga for minorities living with arthritis: ‘Where are the people who look like me?’ Complementary Therapies in Medicine, 31, 82–89. https://doi.org/10.1016/J.CTIM.2017.02.006
• Paxton, R. J., Phillips, K. L., Jones, L. A., Chang, S., Taylor, W. C., Courneya, K. S., & Pierce, J. P. (2012). Associations among physical activity, body mass index, and health-related quality of life by race/ethnicity in a diverse sample of breast cancer survivors. Cancer, 118(16), 4024–4031. https://doi.org/10.1002/cncr.27389

• Symonds, R. P., Lord, K., Mitchell, A. J., & Raghavan, D. (2012). Recruitment of ethnic minorities into cancer clinical trials: experience from the front lines. British Journal of Cancer, 107, 1017–1021. https://doi.org/10.1038/bjc.2012.240

However, it should be noted that ethnic-specific obesity cut points differed. Obesity for Asian Americans were established as BMI  25.0 kg/m2 while obesity for African Americans, Hispanics, and white was established as BMI  30.0 kg/m2. This difference was based on evidence that Asian Americans experience comorbid conditions at lower BMIs than women of other ethnic groups.