Sharing research results with Latina breast cancer survivors who participated in a community-engaged behavioral RCT study: a descriptive cross-sectional survey study

Jackie Bonilla, Alia Alhomsi, Jasmine Santoyo-Olsson, Anita L Stewart, Carmen Ortiz, Cathy Samayoa, Alma Torres-Nguyen, Helen Palomino, La Verne Coleman, Aday Urias, Nayeli Gonzalez, Silvia Araceli Cervantes, Ysabel Duron, Anna María Nápoles, Jackie Bonilla, Alia Alhomsi, Jasmine Santoyo-Olsson, Anita L Stewart, Carmen Ortiz, Cathy Samayoa, Alma Torres-Nguyen, Helen Palomino, La Verne Coleman, Aday Urias, Nayeli Gonzalez, Silvia Araceli Cervantes, Ysabel Duron, Anna María Nápoles

Abstract

Background: An often heard and justifiable concern of ethnic minorities is related to researchers' lack of attention to sharing the results of a study with participants after the study has concluded. Few studies have examined the effects of returning overall study results on participants' attitudes, especially among populations underrepresented in research. Among Latina research participants, providing a summary of study results could enhance participation in research. We assess Latina breast cancer survivors' reactions to receiving study results and their attitudes about participating in future studies.

Methods: For this cross-sectional survey study, all women who had participated in two behavioral randomized controlled trials (RCTs) were mailed a letter summarizing the study results (using written and graphic formats) and a questionnaire assessing problems and understanding the results, importance of sharing results, willingness to participate in future studies, and format preferences for receiving the results. A postage-paid envelope for returning the completed questionnaire was included. Logistic regression examined the associations of age, education, and rural/urban residence on format preferences and willingness to participate. The survey sample consisted of 304 low-income, predominantly Spanish-speaking Latina breast cancer survivors (151 from urban and 153 from rural communities) who had participated in two RCTs testing a stress management program designed for Latina breast cancer survivors.

Results: Ninety-two women returned the questionnaires (30.3%). Most of the women (91.1%) indicated that they had no trouble understanding the results of the study, and 97% agreed that it is very/extremely important for researchers to share the study result with the participants. The majority (60.2%) reported that receiving the results increased their willingness to participate in future studies. About half (51.7%) did not have a format preference, 37.4% preferred written summaries, and 10.9% preferred graphs.

Conclusions: This study is an important first step to understanding the impact of returning study results among a population that is underrepresented in research. Returning the results of studies and understanding the impact of doing so is consistent with maintaining community involvement in all phases of research. The findings suggest that sharing aggregate research results in simple language yields few problems in participants' understanding of the results and is viewed as important by participants.

Trial registration: ClinicalTrials.gov NCT02931552 Date registered: October 13, 2016 and NCT01383174 Date registered: June 28, 2011.

Keywords: Cancer survivors; Community participation; Community-based participatory research; Hispanic Americans; Information dissemination; Language; Literacy; Minority groups; Rural population; Surveys and questionnaires.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Results in English and Spanish

References

    1. Cortés YI, Arcia A, Kearney J, Luchsinger J, Lucero RJ. Urban-dwelling community members’ views on biomedical research engagement. Qual Health Res. 2017;27(1):130–137. doi: 10.1177/1049732315627650.
    1. Scharff DP, Mathews KJ, Jackson P, Hoffsuemmer J, Martin E, Edwards D. More than Tuskegee: understanding mistrust about research participation. J Health Care Poor Underserved. 2010;21(3):879–897. doi: 10.1353/hpu.0.0323.
    1. Flicker S, Travers R, Guta A, McDonald S, Meagher A. Ethical dilemmas in community-based participatory research: recommendations for institutional review boards. J Urban Health. 2007;84(4):478–493. doi: 10.1007/s11524-007-9165-7.
    1. Chastain D, Osae S, Henao A, Franco-Paredes C, Chastain J, Young H. Racial disproportionality in COVID clinical trials. N Engl J Med. 2020;383(9):e59. doi: 10.1056/NEJMp2021971.
    1. Lackland DT, Sims-Robinson C, Jones Buie JN, Voeks JH. Impact of COVID-19 on clinical research and inclusion of diverse populations. Ethn Dis. 2020;30(3):429–432. doi: 10.18865/ed.30.3.429.
    1. Ratneswaren A. The I in COVID: the importance of community and patient involvement in COVID-19 research. Clin Med. 2020;20(4):e120–e1e2. doi: 10.7861/clinmed.2020-0173.
    1. Collins SE, Clifasefi SL, Stanton J, The Leap Advisory B. KJE S, Gil-Kashiwabara E, Rodriguez Espinosa P, Nicasio AV, Andrasik MP, Hawes SM, Miller KA, Nelson LA, Orfaly VE, Duran BM, Wallerstein N. Community-based participatory research (CBPR): towards equitable involvement of community in psychology research. Am Psychol. 2018;73(7):884–898. doi: 10.1037/amp0000167.
    1. Purvis RS, Abraham TH, Long CR, Stewart MK, Warmack TS, McElfish PA. Qualitative study of participants’ perceptions and preferences regarding research dissemination. AJOB Empir Bioeth. 2017;8(2):69–74. doi: 10.1080/23294515.2017.1310146.
    1. Shalowitz DI, Miller FG. The search for clarity in communicating research results to study participants. J Med Ethics. 2008;34(9):e17-e. doi: 10.1136/jme.2008.025122.
    1. Wilkins CH, Mapes BM, Jerome RN, Villalta-Gil V, Pulley JM, Harris PA. Understanding what information is valued by research participants, and why. Health Aff. 2019;38(3):399–407. doi: 10.1377/hlthaff.2018.05046.
    1. Miller FA, Christensen R, Giacomini M, Robert JS. Duty to disclose what? Querying the putative obligation to return research results to participants. J Med Ethics. 2008;34(3):210–213. doi: 10.1136/jme.2006.020289.
    1. Partridge AH, Wolff AC, Marcom PK, Kaufman PA, Zhang L, Gelman R, Moore C, Lake D, Fleming GF, Rugo HS, Atkins J, Sampson E, Collyar D, Winer EP. The impact of sharing results of a randomized breast cancer clinical trial with study participants. Breast Cancer Res Treat. 2009;115(1):123–129. doi: 10.1007/s10549-008-0057-7.
    1. Beskow LM, Burke W, Fullerton SM, Sharp RR. Offering aggregate results to participants in genomic research: opportunities and challenges. Genet Med. 2012;14(4):490–496. doi: 10.1038/gim.2011.62.
    1. Kerasidou A. Sharing the knowledge: sharing aggregate genomic findings with research participants in developing countries. Dev World Bioeth. 2015;15(3):267–274. doi: 10.1111/dewb.12071.
    1. Wong CA, Hernandez AF, Califf RM. Providing individual research results to participants-reply. JAMA. 2018;320(24):2601. doi: 10.1001/jama.2018.18111.
    1. Levac L, Ronis S, Cowper-Smith Y, Vaccarino O. A scoping review: the utility of participatory research approaches in psychology. J Community Psychol. 2019;47(8):1865–1892. doi: 10.1002/jcop.22231.
    1. Long CR, Stewart MK, McElfish PA. Health research participants are not receiving research results: a collaborative solution is needed. Trials. 2017;18(1):449. doi: 10.1186/s13063-017-2200-4.
    1. Chen PG, Diaz N, Lucas G, Rosenthal MS. Dissemination of results in community-based participatory research. Am J Prev Med. 2010;39(4):372–378. doi: 10.1016/j.amepre.2010.05.021.
    1. Napoles AM, Santoyo-Olsson J, Ortiz C, Gregorich S, Lee HE, Duron Y, Graves K, Luce JA, McGuire P, Diaz-Mendez M, Stewart AL. Randomized controlled trial of Nuevo Amanecer: a peer-delivered stress management intervention for Spanish-speaking Latinas with breast cancer. Clin Trials. 2014;11(2):230–238. doi: 10.1177/1740774514521906.
    1. Napoles AM, Santoyo-Olsson J, Stewart AL, Ortiz C, Garcia-Jimenez M. Evaluating the implementation of a translational peer-delivered stress management program for Spanish-Speaking Latina breast cancer survivors. J Cancer Educ. 2018;33(4):875–884. doi: 10.1007/s13187-017-1202-y.
    1. Santoyo-Olsson J, Stewart AL, Samayoa C, Palomino H, Urias A, Gonzalez N, Torres-Nguyen A, Coleman L, Escalera C, Totten VY, Ortiz C, Napoles AM. Translating a stress management intervention for rural Latina breast cancer survivors: the Nuevo Amanecer-II. PLoS One. 2019;14(10):e0224068. doi: 10.1371/journal.pone.0224068.
    1. Napoles AM, Ortiz C, Santoyo-Olsson J, Stewart AL, Gregorich S, Lee HE, Duron Y, McGuire P, Luce J. Nuevo Amanecer: results of a randomized controlled trial of a community-based, peer-delivered stress management intervention to improve quality of life in Latinas with breast cancer. Am J Public Health. 2015;105(Suppl 3):e55–e63. doi: 10.2105/AJPH.2015.302598.
    1. Napoles AM, Santoyo-Olsson J, Stewart AL, Ortiz C, Samayoa C, Torres-Nguyen A, Palomino H, Coleman L, Urias A, Gonzalez N, Cervantes SA, Totten VY. Nuevo Amanecer-II: results of a randomized controlled trial of a community-based participatory, peer-delivered stress management intervention for rural Latina breast cancer survivors. Psychooncology. 2020;29(11):1802–1814. doi: 10.1002/pon.5481.
    1. Garza MA, Quinn SC, Li Y, Assini-Meytin L, Casper ET, Fryer CS, Butler J, 3rd, Brown NA, Kim KH, Thomas SB. The influence of race and ethnicity on becoming a human subject: factors associated with participation in research. Contemp Clin Trials Commun. 2017;7:57–63. doi: 10.1016/j.conctc.2017.05.009.
    1. Echeverri M, Anderson D, Napoles AM, Haas JM, Johnson ME, Serrano FSA. Cancer health literacy and willingness to participate in cancer research and donate bio-specimens. Int J Environ Res Public Health. 2018;15(10):2091. doi: 10.3390/ijerph15102091.
    1. Wendler D, Kington R, Madans J, Van Wye G, Christ-Schmidt H, Pratt LA, Brawley OW, Gross CP, Emanuel E. Are racial and ethnic minorities less willing to participate in health research? PLoS Med. 2006;3(2):e19. doi: 10.1371/journal.pmed.0030019.
    1. Heerman WJ, Wilkins CH, Barkin SL. Disseminating aggregate research findings to participants. Pediatr Res. 2021;89(4):714–715. doi: 10.1038/s41390-020-0995-2.
    1. Flaskerud JH, Anderson N. Disseminating the results of participant-focused research. J Transcult Nurs. 1999;10(4):340–349. doi: 10.1177/104365969901000412.

Source: PubMed

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