URJHS Volume 9

Barriers to Participation in Clinical Trials among Hispanic Cancer Patients

Luis E. Gonzalez
Gwendolyn P. Quinn*
Jessica McIntyre*

University of South Florida

Abstract

Previous research indicates Hispanic cancer patients are severely underrepresented in cancer clinical trials. This study aimed to understand some of the main barriers that may prevent Hispanic cancer patients from participating in clinical trials. A total of 36 Hispanic cancer patients and their caregivers participated in a focus group either in Tampa, Florida or Ponce, Puerto Rico to discuss knowledge of clinical trials. Lack of knowledge about clinical trials, fears, psychological issues, and financial burden were identified by cancer patients and caregivers as major barriers to participation.

Introduction

The Hispanic population represents the fastest growing minority group in the United States and is expected to double in the next 40 years (1).

As Hispanics continue to become more prevalent in the U.S., it becomes necessary to ensure they are equally represented in healthcare research. One way to reach this goal is through increased participation in cancer clinical trials (2). A previous study by Murthy and colleages noted that from 1996 through 2002, only 3.1 percent of the participants in clinical trials for breast, lung, colorectal, and prostate cancers were Hispanic (3). The same study used an enrollment fraction which was defined as the number of trial enrollees divided by the estimated US cancer cases in each ethnic subgroup and found that even after adjusting for the total number of incident cancer cases, Hispanics were underrepresented with a 1.3 percent enrollment fraction compared to the 1.8 percent enrollment fraction of White cancer patients (3).

Recent studies demonstrate variations in genetic makeup among different ethnic groups (4). These genetic differences account for some of the variations in drug response across patients of different races/ethnicities. One example of this is that African Americans may respond more favorably to diuretics and calcium channel blockers than Whites in the treatment of hypertension (5). Furthermore, some Chinese patients tend to be more sensitive to beta-blockers, which may require physicians to alter the dosage when prescribing medication to this group (5). Thus, the low number of Hispanics involved in clinical trials creates a problem for many clinicians because a full spectrum of genetic samples is needed in order to generalize results to all Hispanic cancer patients (6, 7). Whether or not ethnicity plays a role in a specific medication or treatment, investigators must be certain they have completely evaluated the possibility and are able to move on to the next phase in their research (6). In addition to the limits that are placed on science due to the under representation of racial and ethnic minorities, some researchers would argue that Hispanics themselves may be missing out on state-of-the-art cancer care (8). Clinical trials can provide patients with many benefits, and this has been shown by the improvements in survival rates among children with cancer. These improvements can be greatly attributed to the pediatric community’s commitment to clinical trials, as well as the effective treatments discovered during these trials (9). These findings lead researchers to question why there is no sign of increasing participation in clinical trials from a group of individuals who are growing at such a rapid rate. Previous studies on underrepresented populations reported barriers such as mistrust of research, perceived harms, costs of participating, patient demographics, and lack of education about clinical trials (10-14).

Further research targeted at identifying Hispanic’s knowledge about clinical trials and barriers to participation will help develop campaigns and educational resources to ultimately increase participation. The current study sought to explore barriers to participation in cancer clinical trials through focus groups conducted with Hispanic cancer patients and their caregivers.

Methods

Design and Setting

The study was comprised of four focus groups, each containing 8-10 participants (36 participants total). Participants were Hispanic cancer patients/survivors and their caregivers. Two of the focus groups were held at Moffitt Cancer Center in Tampa, Florida and the other two were held at the Ponce School of Medicine in Ponce, Puerto Rico. The objective was to gather cancer patients and caregivers at both sites with varying levels of knowledge, opinions, and experiences with clinical trials. The participants were asked a series of general questions regarding clinical trials and were then shown a compilation of previously developed Spanish educational DVDs focused on clinical trials. Participants were then asked to reflect on the messages, preferences, perceptions, design, and tone of the DVD. Focus groups were audio-recorded and verbatim transcripts were created. The transcripts were examined and used as a guide to create a new DVD in Spanish that will educate the Hispanic community about clinical trials as an alternative.

Participant Recruitment

Candidates for the focus groups included Hispanic cancer patients and their caregivers who reside around Tampa, Florida or Ponce, Puerto Rico. Eligibility criteria for patients were to (a) be > 18 years of age, (b) have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis), (c) be capable of speaking and reading standard Spanish, (d) have a primary diagnosis of cancer, and (e) have completed at least one visit with an oncologist. Eligibility for caregivers were to (a) be > 18 years of age, (b) have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis), (c) be capable of speaking and reading standard Spanish, and (d) report providing care on a regular basis to an individual being treated for cancer in the Tampa Bay area or in Puerto Rico.
Hispanic cancer patients and caregivers in Tampa were recruited through flyers posted throughout Moffitt Cancer Center and at Hispanic community events such as “Salud.” Patients and caregivers in Puerto Rico were recruited through flyers posted at the “Hablemos de Cáncer” event at the Ponce School of Medicine and local radio programs. Individuals who met the eligibility requirements called a 1-800 number to register for the study. All eligible individuals who gave informed consent were assigned to a focus group. After the discussion, participants were compensated with a $25 gift card in recognition of their time.

Data Collection

The focus group moderator described the purpose of the study and explained the participants’ rights. Participants who agreed to be part of the focus group discussion signed a written informed consent. The Institutional Review Board (IRB) in Tampa and Ponce approved procedures. Each focus group was moderated using an interview guide that explored the knowledge of and barriers related to clinical trial participation. The following are examples of questions that guided the focus group discussion: (a) What are some of the reasons you would not participate in a clinical trial? (b) Is there any reason why you would not like to participate in a research study? The focus group discussions took place in a private room and were approximately 90 minutes in length. The discussions were guided by a moderator and an assistant moderator previously trained by the investigators. All focus groups were conducted in Spanish.

Analysis 

The focus group discussions were audio-recorded, transcribed, and translated into English by a certified translator. The transcripts were analyzed using qualitative coding. Through content analysis, key themes were organized related to the identified barriers. Basic descriptive data related to demographic and clinical characteristics were summarized using descriptive statistics such as frequencies and distributions (SPSS V 17.0).

Results

Of the 36 participants, 15 attended a focus group in Tampa, Florida and 21 attended a focus group in Ponce, Puerto Rico. The sociodemographic characteristics of the participants in this study are shown in Table 1. The majority of the participants were more than 50 years old and born in Puerto Rico. Seventy-five percent of the participants were female, and twenty-five percent were male. Slightly more than half of the participants were caregivers and the remaining participants were cancer patients. Breast cancer was the most common type of cancer reported overall by the participants. Tampa focus group participants reported an equal number of breast cancer and pelvic/stomach cancer diagnoses while none of the Puerto Rico participants reported having pelvic/stomach cancer. More than 70 percent of the participants were diagnosed with cancer between 2005 and 2010.

Table 1: Sociodemographic Characteristics of Study Participants (n=36)

	All (n=36) n (%)	Tampa (n=15) n (%)	Puerto Rico (n=21) n (%)
Sociodemographic Characteristics
Age
18 – 30 years old	2 (5.6)	0 (0)	2 (9.5)
31 – 49 years old	9 (25.0)	3 (20.0)	6 (28.6)
50 + years old	25 (69.4)	12 (80.0)	13 (61.9)
Gender Male Female	9 (25.0) 27 (75.0)	3 (20.0) 12 (80.0)	6 (28.6) 15 (71.4)
Country of origin Puerto Rico Colombia United States Nicaragua Ecuador El Salvador Cuba	28 (77.8) 3 (8.3) 1 (2.8) 1 (2.8) 1 (2.8) 1 (2.8) 1 (2.8)	8 (53.3) 3 (20.0) 0 (0) 1 (6.7) 1 (6.7) 1 (6.7) 1 (6.7)	20 (95.2) 0 (0) 1 (4.8) 0 (0) 0 (0) 0 (0) 0 (0)
Education
Less than High School High School or more N/A	7 (19.4) 27 (75.0) 2 (5.6)	2 (13.3) 11 (73.3) 2 (13.3)	5 (23.8) 16 (76.2) 0 (0)
Medical Characteristics
Patient Caregiver	16 (44.4) 20 (55.6)	6 (40.0) 9 (60.0)	10 (47.6) 11 (52.4)
Type of Ca Dx Pelvic/Stomach Breast All Prostate Colorectal Lymphatic Pulmonary with metastasis to bone Pancreas Ovarian Multiple myeloma Brain Leukemia Bones and Stomach Colon N/A	4 (11.1) 10 (27.8) 1 (2.8) 3 (8.3) 2 (5.6) 2 (5.6) 2 (5.6) 2 (5.6) 2 (5.6) 2 (5.6) 2 (5.6) 1 (2.8) 1 (2.8) 1 (2.8) 1 (2.8)	4 (26.7) 4 (26.7) 1 (6.7) 1 (6.7) 0 (0) 1 (6.7) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 (6.7) 1 (6.7) 1 (6.7) 1 (6.7)	0 (0) 6 (28.6) 0 (0) 2 (9.5) 2 (9.5) 1 (4.8) 2 (9.5) 2 (9.5) 2 (9.5) 2 (9.5) 2 (9.5) 0 (0) 0 (0) 0 (0) 0 (0)
Year of Ca Dx
1980-1994 1995-1999 2000-2004 2005-2010	3 (8.3) 2 (5.6) 5 (13.9) 26 (72.2)	1 (6.7) 2 (13.3) 4 (26.7) 8 (53.3)	2 (9.5) 0 (0) 1 (4.8) 18 (85.7)

 

Focus Group Results

The focus group facilitator asked participants to consider what the barriers to participation in cancer clinical trials might be. Four key themes, displayed in Figure 1, focused on lack of knowledge about clinical trials, fears, psychological issues, and financial burden.

Figure 1: Main Barriers to Participation

Theme	Example
Lack of knowledge about clinical trials	Limited information about clinical trials in terms that best suit the Hispanic population
Fear (1) of new treatment	Uncertainties about side effects
Fear (2) of being treated as a test subject	Reluctant to be considered guinea pigs
Psychological Issues	Denial or depression
Financial Burden	Inability to pay for treatments in clinical trials

 

Lack of Knowledge about Clinical Trials - Both patients and caregivers admitted having a poor understanding of what a clinical trial truly is.

"If I don't have any knowledge about the study in which I'm asked to participate, I can't participate because I don't know anything."

Some participants suggested there is not enough information targeted to Hispanics and described the available information on clinical trials as too scientific for them to understand.

"I think there should be more information, especially [targeted] to the Spanish-speaking community."

"It's how the information is delivered to you…The person must have very clear information in their own language, in terms that are not so scientific."

A few caregivers felt that patients were not provided with ample time to make an educated decision.

"And then [they should] give you some time to think…let me read it and later we meet when I know what it is about."

Fear - Two main fears emerged from the focus group data: (a) fear of new treatment or unknown drugs and (b) fear of being treated as a test subject. Most mentioned fear related to concerns about new treatments and unknown drugs.

"You are a bit afraid of the medication causing you an [allergic] reaction…they don't tell you the medication name."

"You don't know what you're taking and you could even die and nobody knows of what."

Many participants said they were scared of side effects that may be associated with the treatment. Another patient also reported the cultural misperception that if the treatment does not work, the participant will die.

"There are side effects…some things happen that affect you, and then you find out that they could be associated with [the treatment].”

"They are testing me like I am a mouse and if it doesn't work, I die…"

A fear of being treated as a test subject was the other barrier reported by participants. Some patients referred to clinical trial participants as guinea pigs and/or lab rats.

"I had heard people talking about us [being] guinea pigs."

“I am not going to allow myself to be a guinea pig… I have not taken any medication. Instead, [my participation has been] based on seminars and I have learned a lot that way.”

Fewer participants reported cultural issues with clinical trials related to negative images and misperceptions among Hispanics.

"People in Puerto Rico are afraid of trying new things because we are told we are being used as guinea pigs."

When one patient reflected on the use of Puerto Rican women to try the contraceptive pill in the 1950’s, many of the other participants attested to the impact that it had on their population.

"…historically in the 50's, Puerto Rican women were used to try the contraceptive pill. They gave some medications that caused other long-term situations in the population…We still have this thing that we are being used."

"…that fear of being utilized, and we don't like being utilized."

Psychological Issues - Many patients reported they would not participate in a clinical trial due to psychological reasons such as denial or depression.

"Sometimes they refuse to be in a study, even knowing that they have a disease, so they don't have to face it."

"Sometimes they are afraid to face the disease, to face the consequences."

Some of the caregivers mentioned a family history of struggles with cancer as a reason to refuse a clinical trial.

"For instance my mother, when she had breast cancer I suffered a lot…I was at a time where I couldn't speak about cancer because I found it terrifying."

"There was no consideration with my mom. My mom was terrified and didn't want to participate in anything."

Financial Burden- Many participants mentioned an uncertainty about which expenses they were required to cover as well as the inability of insurance plans to cover the costs of treatment.

"You are in [treatment] for a while, and out of the blue here they come with a bill this big and…You are dead! Because how are you going to pay for it?"

"I only have one health insurance plan, and that plan is not going to cover me."

Other patients recognized financial expenses as a primary concern for participants.

"One of the things that affects or concerns [patients] the most is, how much is it going to cost me? Do I have to pay?”

"…within all areas, time, because I could not participate in a study; I work all the time."

Discussion

The primary purpose of this study was to identify the barriers that are faced by Hispanic cancer patients and their caregivers when deciding to participate in a clinical trial. Lack of knowledge about clinical trials was the most commonly reported barrier among all participants. This is consistent with previous studies that have identified lack of culturally relevant information about clinical trials as a major barrier (10, 11, 13, 14). One way this information could be delivered to the patient is through his/her physician. However, Powell and colleagues have reported that a lack of awareness about clinical trials among physicians significantly contributes to the low number of clinical trial referrals given to patients (14). Physicians should be a resource of information for Hispanic cancer patients who know little about clinical trials as a treatment option.

Fear of new treatment is often seen among various clinical trial patients, whether Hispanic or non-Hispanic (10, 14). Nevertheless, Katz and colleagues believe Hispanics are especially wary of side effects; according to Katz, Hispanics perceive themselves to be at a greater risk than Whites when participating as research subjects (15). The number of participants who recalled unethical clinical trials involving contraceptive testing shows this mistrust of research by the Hispanic community. These experiments, which caused an increase in sterility among many Puerto Rican women, may have contributed to the existing fears that are commonly shared among Hispanics (16).

Psychological issues were frequently reported as a barrier to clinical trial participation by caregivers. The reports of denial, depression, and personal suffering were consistent with previous research by Nijboer et al. who found that alterations in patient functional ability create a burden on the caregiver (17). Further studies have found increasing care-giving burden is a significant correlate to symptoms of depression in caregivers of patients with lung cancer (18, 19).

Many patients reported they would refuse a clinical trial due to financial burden. Cost has been previously identified as a major barrier to clinical trial participation (11, 20). The patients in the study referenced an uncertainty about which costs they were responsible for, as well as not having the means to cover the charges. These economic pressures have been classified as resource constraints by McCaskill-Stevens et al. and are believed to have a substantial impact on a patient’s rejection of participation in a clinical trial (14).

Limitations of the study

It is important to note that this study is limited to the perspectives of the focus group participants and is not representative of the entire Hispanic population. Another limitation of this study is the combination of cancer patients and caregivers in the focus groups. There may have been some distinctions between the answers given by the cancer patients and caregivers if they were enrolled in separate focus groups. Future research should analyze the responses of cancer patients and caregivers separately to gain insight on the different perspectives.

Conclusion

Now that the data have been collected and analyzed, our next steps are to film an educational DVD about clinical trials and distribute copies to Hispanic patients diagnosed with cancer. The DVD will include general information about clinical trials in addition to interviews with clinical trial participants and physicians. More research is needed to gather a complete understanding of the barriers to clinical trial participation. However, using Spanish educational DVDs, increasing physician awareness, and providing financial aid to low-income patients can lower some of the known barriers to clinical trial participation.

References

1. US Census Bureau. Census Factfinder.

2. NIH. (2000) Understanding Clinical Trials. http://www.clinicaltrials.gov/ct2/info/understand ed.: U.S. National Library of Medicine.

3. Murthy, V., Krumholz, H., and Gross, C. (2004) Participation in cancer clinical trials: race-, sex-, and age-based disparities. Jama 291, 2720.

4. Burchard, E., Ziv, E., Coyle, N., Gomez, S., Tang, H., Karter, A., Mountain, J., Pérez-Stable, E., Sheppard, D., and Risch, N. (2003) The importance of race and ethnic background in biomedical research and clinical practice. New England Journal of Medicine 348, 1170.

5. Katzung, B., Masters, S., and Trevor, A. (1998) Basic & clinical pharmacology. Appleton & Lange Norwalk, CT.

6. Corbie-Smith, G., Miller, W.C., and Ransohoff, D.F. (2004) Interpretations of 'appropriate' minority inclusion in clinical research. Am J Med 116, 249-252.

7. Risch, N., Burchard, E., Ziv, E., and Tang, H. (2002) Categorization of humans in biomedical research: genes, race and disease. Genome Biol 3, comment2007.

8. Outlaw, F., Bourjolly, J., and Barg, F. (2000) A study on recruitment of black Americans into clinical trials through a cultural competence lens. Cancer Nursing 23, 444.

9. Sateren, W., Trimble, E., Abrams, J., Brawley, O., Breen, N., Ford, L., McCabe, M., Kaplan, R., Smith, M., and Ungerleider, R. (2002) How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. Journal of Clinical Oncology 20, 2109.

10. Ford, J.G., Howerton, M.W., Lai, G.Y., Gary, T.L., Bolen, S., Gibbons, M.C., Tilburt, J., Baffi, C., Tanpitukpongse, T.P., Wilson, R.F., Powe, N.R., and Bass, E.B. (2008) Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer 112, 228-242.

11. Killien, M., Bigby, J., Champion, V., Fernandez-Repollet, E., Jackson, R., Kagawa-Singer, M., Kidd, K., Naughton, M., and Prout, M. (2000) Involving minority and underrepresented women in clinical trials: The National Centers of Excellence in Women's Health. Journal of Women's Health & Gender-Based Medicine 9, 1061-1070.

12. Ellington, L., Wahab, S., Martin, S., Field, R., and Mooney, K. (2006) Factors that influence Spanish-and English-speaking participants' decision to enroll in cancer randomized clinical trials. Psycho-oncology 15, 273-284.

13. Powell, J., Fleming, Y., Walker-McGill, C., and Lenoir, M. (2008) The project IMPACT experience to date: increasing minority participation and awareness of clinical trials. Journal of the National Medical Association 100, 178-187.

14. McCaskill-Stevens, W., McKinney, M.M., Whitman, C.G., and Minasian, L.M. (2005) Increasing minority participation in cancer clinical trials: the minority-based community clinical oncology program experience. J Clin Oncol 23, 5247-5254.

15. Katz, R., Wang, M., Green, B., Kressin, N., Claudio, C., Russell, S., and Sommervil, C. (2008) Participation in biomedical research studies and cancer screenings: perceptions of risks to minorities compared with whites. Cancer control: journal of the Moffitt Cancer Center 15, 344.

16. Lapp, M. (1995) The Rise and Fall of Puerto Rico as a Social Laboratory, 1945-1965. Social Science History 19, 169-199.

17. Nijboer, C., Tempelaar, R., Sanderman, R., Triemstra, M., Spruijt, R., and Van Den Bos, G. (1998) Cancer and caregiving: the impact on the caregiver's health. Psycho-oncology 7, 3-13.

18. Kim, Y., Duberstein, P., Sorensen, S., and Larson, M. (2005) Levels of depressive symptoms in spouses of people with lung cancer: effects of personality, social support, and caregiving burden. Psychosomatics 46, 123.

19. Blanchard, C., Albrecht, T., and Ruckdeschel, J. (1997) The crisis of cancer: Psychological impact on family caregivers. Oncology-Huntington 11, 189-195.

20. Giuliano, A., Mokuau, N., Hughes, C., Tortolero-Luna, G., Risendal, B., Ho, R., Prewitt, T., and Mccaskill-Stevens, W. (2000) Participation of minorities in cancer research: the influence of structural, cultural, and linguistic factors. Annals of Epidemiology 10, S22.