Awareness Of Cancer Clinical Trials Research Articles

Addressing disparities in cancer clinical trials: a roadmap to more equitable accrual.

The Georgia Center for Oncology Research and Education (Georgia CORE) and the Georgia Society of Clinical Oncology (GASCO) held a one-day summit exploring opportunities and evidence-based interventions to address disparities in cancer clinical trials. The purpose of the summit was to identify clear and concise recommendations aimed at decreasing clinical trial accrual disparities in Georgia for rural and minority populations. The summit included expert presentations, panel discussions with leaders from provider organizations throughout Georgia, and breakout sessions to allow participants to critically discuss the information presented. Over 120 participants attended the summit. Recognizing the need for evidence-based interventions to improve clinical trial accrual among rural Georgians and persons of color, summit participants identified four key areas of focus that included: improving clinical trial design, providing navigation for all, enhancing public education and awareness of cancer clinical trials, and identifying potential policy and other opportunities. A comprehensive list of takeaways and action plans was developed in the four key areas of focus with the expectation that implementation of the strategies that emerged from the summit will enhance cancer clinical trial accrual for all Georgians.

Abstract D067: The REACT study: A feasibility study to develop and test the integration of a California Cancer Registry Early Case Ascertainment process via electronic pathology reporting with an online clinical trial matching tool

Abstract Background: Representation of diverse patient populations in prostate cancer clinical trials is essential to ensure that trial results are applicable to all affected men. However, underrepresentation among racial/ethnic minorities remains a critical problem in cancer research. Population-based cancer registries provide a potential platform to overcome problems with inclusion of diverse patient populations in clinical research if they are used as a source for recruitment. Methods: Leveraging the statewide implementation of electronic pathology (e-path) for cancer case identification, we performed a pilot feasibility study, REACT (Registry Early case Ascertainment process via e-path with an online Clinical Trial matching tool), within the Greater Bay Area Cancer Registry to (1) develop and test a process using e-path to rapidly identify new cases of advanced prostate cancer for potential enrollment into existing prostate cancer clinical trials; and (2) test the utility of an online clinical trial matching tool used in combination with e-path to improve matching of underrepresented patients into advanced prostate cancer clinical trials. All study materials were translated into Spanish, and a Spanish-speaking bilingual recruiter is one of two recruiters. This study will accrue 50 patients. Results: Thus far, a total of 224 cases were identified from 19 reporting facilities through e-path and 213 (92%) were sent invitation letters. We have initiated recruitment contact calls with N=101; of these, 11 were excluded due to physician-indicated contraindication, and 17 (17%) declined participation. To date, 12 patients have enrolled in the study, 10 of whom completed baseline surveys, and 4 subsequently completed follow-up surveys after using the online matching tool. The majority (N=7) of participants were NH White; of higher income, >$150,000 (N=6); and of higher education, >bachelor’s/associate degree (N=8). Nine participants indicated use of the internet to learn about prostate cancer and 4 found internet prostate-cancer related information very useful. Nine participants reported receipt of prostate cancer treatment in the past 3 months, 8 received hormonal therapy, 4 received radiation, and 2 received surgery. To assess research knowledge and attitudes, 7 indicated awareness of cancer clinical trials, 6 indicated interest in participating in clinical research, 7 held a positive and 3 held a neutral attitude towards cancer clinical trials, however 5 indicated that they would not participate in a randomized study. To assess utility of the matching tool, 2 indicated it increased their interest in participating in clinical trials. Discussion: As the study progresses, we will focus effort on recruitment of underserved patients. However, thus far, preliminary results indicate that e-path used in combination with an online clinical trial matching tool may serve as an important recruitment vehicle for prostate cancer clinical trials. Citation Format: Hala T Borno, Christine Duffy, Sylvia Zhang, Todd Golden, Zinnia Loya, Debby Oh, Anobel Odisho, Scarlett Lin Gomez. The REACT study: A feasibility study to develop and test the integration of a California Cancer Registry Early Case Ascertainment process via electronic pathology reporting with an online clinical trial matching tool [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr D067.

REACT: A feasibility study to test the integration of a cancer registry early case ascertainment process via electronic pathology reporting with an online clinical trial matching tool.

207 Background: Representation of diverse patient populations in prostate cancer clinical trials is essential to ensure results are applicable to all men. However, underrepresentation among underserved populations remains a critical problem. Population-based cancer registries provide a potential platform to overcome problems with inclusion of diverse patient populations in clinical research when used as a source for recruitment. Methods: Leveraging statewide implementation of early-case ascertainment (ECA) via electronic pathology for cancer case identification, we performed a feasibility study within the Greater Bay Area Cancer Registry to (1) test a process using ECA to identify new cases of advanced prostate cancer for potential enrollment into clinical trials and (2) test the utility of an online clinical trial matching tool to improve matching of underrepresented patients into clinical trials. All study materials were translated into Spanish, and recruiters were Spanish-speaking. Results: A total of 419 cases were identified from 19 reporting facilities through ECA and sent invitation letters; 18 cases were excluded due to physician contraindication, and 68 (16%) declined participation. All enrolled participants (N=54) completed baseline surveys. To date, 40 participants completed follow-up surveys after using the online matching tool. Most participants were White (80%), of higher income (>$150,000; 41%), and college-educated (70%). Thirty-seven percent indicated awareness of cancer clinical trials, 69% stated interest in participating in clinical research, and 72% held a positive attitude towards cancer clinical trials. However, 46% indicated they would not participate in a randomized study. To assess utility of the matching tool, 65% indicated it increased their interest in participating in a clinical trial. Conclusions: ECA needs to ensure sociodemographic data are available to make it useful as a tool for clinical trials. Preliminary results indicate ECA used in combination with an online clinical trial matching tool may serve as an important recruitment vehicle for prostate cancer clinical trials.

Evaluating stress, satisfaction and the associated influencing factors of participants in cancer clinical trials: a cross-sectional study in China

ObjectivesPatients’ stress and satisfaction concerning cancer clinical trials (CCT) may affect study accrual and quality. Our study aimed to evaluate stress and satisfaction in CCT and the influencing factors.DesignCross-sectional analysis...

A community-academic partnership to explore informational needs of African American women as a primer for cancer clinical trial recruitment

ABSTRACTBackground: African Americans (AAs) are less likely to participate in cancer clinical trials (CCTs) despite experiencing disproportionately higher rates of cancer mortality. As a way to address these ongoing disparities, this study sought to qualitatively explore informational needs regarding CCTs among AA women and identify message considerations for educational information targeting AA women and their community.Methods: Three focus groups were conducted in which AA women viewed a DVD created as a decisional tool for CCT participation and provided feedback regarding content.Results: Results indicated general fear regarding CCTs, which is partially attributable to the impact of historic research abuses, lack of information regarding CCTs, and lack of cultural relevance of the education and outreach materials for AA communities. Recruitment of AAs to CCTs may be enhanced by educational and outreach approaches that increase awareness of CCTs as well as involvement of the AA community in developing such interventions.Conclusion: Interventions should include the perspectives of AA women, as key stakeholders and decision-makers for their family and provide research information in a multimedia format that will facilitate family discussion and decision-making regarding CCTs.

Empowering Promotores de Salud as partners in cancer education and research in rural southwest Kansas.

To describe community-based participatory processes used to develop promotore training on cancer research, and to assess the feasibility of training promotores from rural communities to disseminate cancer research information. Prospective, cohort design. Rural communities in the state of Kansas. 34 Spanish-speaking promotores attended an information session; 27 enrolled and 22 completed training. With input from a community advisory board, the authors developed a leadership and cancer curriculum and trained Spanish-speaking promotores to disseminate information on cancer research. Promotores completed pretraining and post-training surveys in Spanish to assess demographic characteristics and changes in knowledge of cancer, cancer treatment and cancer research studies, and intent to participate in cancer research. Cancer knowledge, awareness of cancer clinical trials, interest in participating in cancer clinical research studies. Compared to pretraining, after training, promotores were more likely to correctly define cancer, identify biopsies, describe cancer stages, and report ever having heard of cancer research studies. Completion rates of the training and willingness to participate in cancer research were high, supporting the feasibility of training promotores to deliver community-based education to promote cancer research participation. Nursing professionals and researchers can collaborate with promotores to disseminate cancer education and research among underserved rural Latino communities in Kansas and elsewhere. Members of these communities appear willing and interested in improving their knowledge of cancer and cancer clinical trials.

Improving Awareness of Cancer Clinical Trials Among Hispanic Patients and Families: Audience Segmentation Decisions for a Media Intervention

Clinical trials hold great promise for cancer treatment; yet, Hispanic cancer patients have low rates of clinical trial participation. Lack of awareness and knowledge of clinical trials and language barriers may account for low participation rates. Patient education through audiovisual materials can improve knowledge of and attitudes toward clinical trials among Hispanic populations. In this study, 36 Hispanic cancer patients/survivors and caregivers in Florida and Puerto Rico participated in focus groups to aid in developing a Spanish-language DVD and booklet intervention designed to increase knowledge about clinical trials. Focus group results showed (a) low levels of knowledge about clinical trials, (b) uncertainty about why a physician would expect a patient to make a choice about treatment, and (c) desire for family participation in decision making. Respondents expressed various preferences for aspects of the DVD such as showing extended family in the DVD and physician explanations about key terms. On the basis of these preferences, the authors developed a creative brief for a DVD. The content of the DVD was reviewed by Hispanic community leaders and key stakeholders. A final DVD was created, in Spanish, using Hispanic patients and physicians, which contained the information deemed important from the focus groups and stakeholder interviews. The DVD is complete with companion booklet and currently undergoing a randomized control trial.

Abstract A25: Reaching diverse populations about cancer clinical trials: Lessons learned from ENACCT's pilot education program

Abstract Adult participation in cancer clinical trials (CCTs) nationally remains less than 5%, with even fewer participants among communities of color. Barriers to participation are experienced by patients, providers, as well as research staff. Efforts to improve diverse populations’ interest and participation in cancer clinical trials requires a multipronged approach targeting key stakeholders. The Education Network to Advance Cancer Clinical Trials (ENACCT) is the only national organization solely devoted to evidence-based, community-centered approaches to CCTs education. In 2006, ENACCT launched the Pilot Education Program (PEP), a 3-year initiative which sought to improve CCT awareness, access, and accrual, particularly among medically underserved populations. Three diverse PEP community sites (Boston MA, Tacoma WA, and Decatur, IL) participated in training of community leaders (CLs) and health care providers (HCPs), using an action-oriented train the trainer curriculum that addressed cancer health disparities, past research abuses, and current patient protections, as well as the significance of diverse CCTs participation as a social justice issue. Multiple training modules, as well as educational “palm cards” were translated to Spanish and Korean. Workshops for CCT staff focused on strategies to improve recruitment and retention practices to reach medically underserved populations, highlighting the role of Culturally and Linguistically Appropriate Services (CLAS) standards in the clinical research setting. PEP reached 461 HCPs (62% nurses), 926 CLs (66% minority) and 61 CCT staff (13% minority) in educational workshops. Four thousand individuals were reached through community presentations and over 49,000 educational palm cards were distributed. Post training, over 60% of CLs trained said they shared messages about CCTs with at least one other person. HCP trainees had more favorable attitudes and beliefs regarding CCTs and HCPs’ role in CCT referral from pre-to post-workshop assessment. Additionally, at first assessment post-training, 81 % of CLs, 95% of HCPs and 94% of CCT staff agreed that equal access to CCTs is a matter of social justice. Nearly 100 unique patient profiles were created via a national CCTs matching service. ENACCT's training overall positively improved recognition of CCTs access and participation as a social justice issue among stakeholders. Successful community based interventions on CCTs must meet the needs of diverse populations by (1) tailoring key education messages to be culturally relevant and (2) building synergistic relationships among stakeholders to reduce barriers to trial access. Citation Information: Cancer Epidemiol Biomarkers Prev 2010;19(10 Suppl):A25.

Overcoming barriers to cancer clinical trial accrual

Annually, only 3% of adult patients participate in cancer clinical trials (CCT). Accrual barriers include lack of CCT awareness and uncertain third-party coverage. In 2002, a California law (SB37) required all insurers to reimburse costs related to CCT. The objective of the current study was to increase awareness of CCT and SB37 through a mass multimedia campaign (MMC) in the University of California (UC) Davis (UCD) Cancer Center catchment area. The authors assessed willingness to participate in and accrual to CCT. Changes in CCT/SB37 awareness and willingness to participate were investigated before the MMC versus after the MMC and in UCD respondents versus UC San Diego (UCSD) catchment respondents-a control group that was not exposed to the MMC-by Pearson chi-square and logistic regression analyses. Of 1081 post-MMC respondents, 957 were from UCD, and 124 from UCSD. UCD respondents had a greater awareness of CCT (59% vs 65%; P < .01) and SB37 (17% vs 32%; P < .01) compared with UCSD respondents. Willingness to participate did not change in either cohort. Awareness level predicted willingness (odds ratio, 2.3; P < .01). Blacks, Asians, and lowest income (<$25 K per year) groups were the least willing to participate (P < .01, P < .04, and P < .02, respectively). The CCT accrual rate at UCD was unchanged. CCT and SB37 awareness increased significantly in the UCD cohort after the MMC. However, it was unclear whether this increase was attributable entirely to the MMC or to varying demographic variables. Enhancing patient willingness and accrual will require targeting other variables, such as physician or resource barriers, rather than just CCT and reimbursement awareness.

Cancer clinical trials (CCT) awareness and attitudes in cancer survivors (Ca surv)

6061 Background: A web-based survey of attitudes and awareness of Ca surv towards CCT was performed from 3–4, 2005. The survey instrument was developed jointly by the Coalition of Cancer Cooperative Groups (CCCG) and Northwestern Univ (NU) and executed by NU and Knowledge Networks (KN). Methods: Ca surv were obtained from a panel of 40,000 adults through KN, based on a US households national probability sample who agree to weekly surveys in exchange for a free WebTV box and ISP service. 2,029 panel members reported a cancer diagnosis. 1,788/2,029 (88%) agreed to participate. Results: Ten-percent of Ca surv were aware that CCT participation was an option. In 73%, a physician was the source of the CCT awareness. Awareness was related to time since diagnosis (&lt; 9 yrs vs &gt; 9yrs); gender (females &gt; males); age (younger &gt; older), and education (baccalaureate vs less). Awareness varied according to cancer type: leukemia, 26%; breast, 15%; lymphoma and lung, 14%; prostate, 12%; melanoma and renal cell, 10%; colorectal and bladder; 6–3%. Awareness was dependent (p &lt; .01) on type of treatment: surgery 5% (n, 880); surgery and RT, 7% (n, 181); RT, 10% (n, 107); chemotherapy, 18% (n, 488). Of the last group, 44% enrolled into CCT; 33% declined and 11% were either ineligible or not offered a CCT. Those who declined were concerned that the new approach might be “less effective” (40%) and about “randomization” (18%). CCT Ca surv reported a high level of satisfaction on a 0 (worst) to 10 (best) scale: “treated with dignity and respect”, 9.6; “overall very positive experience”, 9.3; “recommend to a family member or friend”, 8.8. Conversely, the response to “I felt like a guinea pig” was 1.7. Conclusions: In summary, assessing issues such as awareness, participation and accrual onto CCT must adjust for key demographic, disease and treatment related factors. The CCT experience is valued and appreciated by Ca surv as they move the field forward. No significant financial relationships to disclose.

Impact of a mass media campaign (MMC) on awareness of and willingness to participate in cancer clinical trials (CCT): Results from 2,269 survey respondents

6012 Background: Annually, only 3% of patients (pt) participate in CCT. Accrual barriers include lack of CCT awareness and uncertain third party coverage. In 1/02, a California law (SB37) required all third party payers to reimburse pt care costs related to CCT. We sought to increase awareness of CCT/SB37 through a MMC, and assessed willingness to participate. Methods: Following a pre-MMC survey of 1,188 cancer pt and/or their caregivers’ awareness and willingness levels (JCO 2005; 23:9282–89), a TV/radio/print/internet MMC was conducted in a 9-county catchment area for UC Davis Cancer Center from 4/05–6/05. The MMC emphasized CCT/SB37 availability and used an iconic “Big C” logo. The survey was repeated post-MMC in two pt/caregiver cohorts: from the UC Davis Cancer Center catchment area (C1), and a control group from the UC San Diego area (C2) who did not see the MMC. Changes in CCT/SB37 awareness and willingness to participate were probed pre- vs. post-MMC and C1 vs. C2 by Pearson χ2 &amp; logistic regression. Results: Of 2,269 respondents, 1,081 were post-MMC: 957 from C1 and 124 from C2. Post-MMC respondents differed from pre-MMC by respondent type (pt &gt; caregivers), age (older), race (more blacks), and income (more $75k+/yr). Pre- vs. post-MMC, C1 respondents had greater awareness of CCT (59% to 65%, p &lt; 0.01) and SB37 (17% vs. 32%, p &lt; 0.01); no significant change was seen in C2. Adjustment for demographic variables in C1 resulted in p &gt; 0.05 for CCT/SB37 awareness. Willingness to participate in CCT did not change pre- vs. post-MMC in C1 or C2. Awareness level predicted willingness (OR = 2.3, p &lt; 0.01), but this was not true for the lowest income/education groups. Blacks/Asians/lowest income (&lt; $25K/yr) groups were least willing to participate (p &lt; 0.01/0.04/0.02). Conclusions: Although CCT/SB37 awareness increased in C1 following the MMC, it is unclear whether this was wholly attributable to the MMC due to varying demographic variables. Awareness of CCT/SB37 did not universally translate into willingness to participate in all subgroups. Enhancing pt willingness (to increase CCT accrual) will require targeting other variables, such as physician or resource barriers, rather than just CCT/SB37 awareness. (R21 CA-03501). No significant financial relationships to disclose.

Evaluation of Factors Affecting Awareness of and Willingness to Participate in Cancer Clinical Trials

Annually, only 3% of patients participate in cancer clinical trials (CCTs). Barriers to accrual include lack of CCT awareness and uncertain third-party payer coverage. In January 2002, a California law (Senate Bill 37 [SB37]) required all third-party payers to reimburse patient care costs related to CCTs. We evaluated the level of awareness of patients and/or their family members/friends regarding CCTs and SB37. We used both a written survey for patients and/or their family members and friends seen in oncology clinics, and a verbal telephone version for Cancer Information Service callers. We tested for correlations between CCT awareness and SB37 knowledge, and willingness to participate in CCTs. Of 1,188 respondents, 59% were aware of CCTs, 19% knew of SB37, and 36% were very likely to consider a CCT. There were significant positive correlations between CCT awareness and willingness to participate (P < .001, Spearman), and between SB37 knowledge and willingness to participate (P = .001, Pearson chi2). Reduced awareness was seen in respondents who were either black or African American (odds ratio [OR], 0.44; P = .004), Hispanic (OR, 0.56; P = .03), had an annual income less than 25,000 dollars (OR, 0.38; P < .001), or had less than a college degree (OR, 0.12 to 0.53; P < .001 to .013). Reduced willingness to participate in CCTs was seen in black or African American participants (OR, 0.38; P < .001), Asians (OR, 0.44; P < .006), or respondents aged 18 to 24 years (OR, 0.35; P = .002). These results support the hypothesis that improving CCT awareness and SB37 knowledge especially among lower income, less educated, and minority patients, may potentially overcome barriers to participation and subsequently increase accrual in California.

Overcoming barriers to accrual: An assessment of 1,187 cancer patients’ (Pts) and caregivers’ awareness of and willingness to participate in cancer clinical trials (CCTs)

6016 Background: Only 3% of pts participate annualy in CCTs. Barriers to accrual include lack of CCT awareness and uncertain third party payer coverage. In January 2002, a new California law (Senate Bill 37 [SB37]) required all third party payers to reimburse pt care costs related to CCTs. We evaluated the level of awareness of pts and/or their caregivers regarding CCTs and SB37. Methods: We employed both a written survey for pts and/or caregivers seen for the first time in an oncology clinic within the UCDCC catchment area, and a verbal telephone version for callers to the CIS. We used Spearman’s correlation and Pearson’s Chi-Square to test for correlations between CCT “awareness” (subjects had heard of CCT and agreed that it tests the safety and usefulness of a new drug)/SB37 knowledge, and willingness to participate in CCTs. Logistic regression was performed to assess predictive variables for awareness and willingness to participate. Results: Of the 1,187 respondents, 59% were aware of CCTs, 19% knew of SB37, and 33% were very likely to consider a CCT. There were significant positive correlations between CCT awareness and willingness to participate (p<0.0001, Spearman), and between SB37 knowledge and willingness to participate (p=0.0012, Pearson Chi-square). Reduced awareness of CCTs was seen in respondents who were either Black (odds ratio [OR] 0.44, p=0.0036), Hispanic (OR 0.56, p=0.03), had an annual income <$25,000 (OR 0.38, p<0.0001), or had less than a college degree (OR 0.12 to 0.53, p<0.0001 to 0.013). Reduced willingness to participate in CCTs was seen in respondents who were either Black (OR 0.38, p<0.0001), or Asian (OR 0.44, p<0.0057). Conclusions: Improving clinical trial awareness and SB37 knowledge, especially among lower income, less educated, and minority pts, may potentially overcome barriers to CCT participation and subsequently increase accrual in California. (R21 CA10172; VANCHCS; ACS CRTG 00197101CCE to PNL) No significant financial relationships to disclose.