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Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention

Kumar, Nagi B; Pow-Sang, Julio; Egan, Kathleen M; Spiess, Philippe E; Dickinson, Shohreh; Salup, Raoul; Helal, Mohamed; McLarty, Jerry; Williams, Christopher R; Schreiber, Fred; Parnes, Howard L; Sebti, Said; Kazi, Aslam; Kang, Loveleen; Quinn, Gwen; Smith, Tiffany; Yue, Binglin; Diaz, Karen; Chornokur, Ganna; Crocker, Theresa; Schell, Michael J
Preclinical, epidemiologic, and prior clinical trial data suggest that green tea catechins (GTC) may reduce prostate cancer risk. We conducted a placebo-controlled, randomized clinical trial of Polyphenon E (PolyE), a proprietary mixture of GTCs, containing 400 mg (-)-epigallocatechin-3-gallate (EGCG) per day, in 97 men with high-grade prostatic intraepithelial neoplasia (HGPIN) and/or atypical small acinar proliferation (ASAP). The primary study endpoint was a comparison of the cumulative one-year prostate cancer rates on the two study arms. No differences in the number of prostate cancer cases were observed: 5 of 49 (PolyE) versus 9 of 48 (placebo), P = 0.25. A secondary endpoint comparing the cumulative rate of prostate cancer plus ASAP among men with HGPIN without ASAP at baseline, revealed a decrease in this composite endpoint: 3 of 26 (PolyE) versus 10 of 25 (placebo), P < 0.024. This finding was driven by a decrease in ASAP diagnoses on the Poly E (0/26) compared with the placebo arm (5/25). A decrease in serum prostate-specific antigen (PSA) was observed on the PolyE arm [-0.87 ng/mL; 95% confidence intervals (CI), -1.66 to -0.09]. Adverse events related to the study agent did not significantly differ between the two study groups. Daily intake of a standardized, decaffeinated catechin mixture containing 400 mg EGCG per day for 1 year accumulated in plasma and was well tolerated but did not reduce the likelihood of prostate cancer in men with baseline HGPIN or ASAP.
PMCID:4596745
PMID: 25873370
ISSN: 1940-6215
CID: 2588652

The importance of assessing priorities of reproductive health concerns among adolescent and young adult patients with cancer

Murphy, Devin; Klosky, James L; Reed, Damon R; Termuhlen, Amanda M; Shannon, Susan V; Quinn, Gwendolyn P
Visions for the future are a normal developmental process for adolescents and young adults (AYAs) with and without cancer, and these visions often include expectations of sexual and romantic relationships. AYA cancer survivors indicate reproductive health is an issue of great importance and more attention is needed in the health care setting throughout the cancer experience, beginning at diagnosis. Various practice guidelines are predominately focused on fertility; are intended to influence survivorship care plans; and do not encompass the broad scope of reproductive health that includes romantic partnering, friendships, body image, sexuality, sexual identity, fertility, contraception, and more. Although interventions to reduce reproductive health-related sequelae from treatment are best approached as an evolving process, practitioners are not certain of the priorities of these various reproductive health content areas. Strategies incongruent with the reproductive health priorities of AYAs will likely thwart adequate follow-up care and foster feelings of isolation from the treatment team. Research is needed to identify these priorities and ensure discussions of diverse content areas. This review explored various domains of reproductive health and emphasized how understanding the priorities of the AYA cancer cohort will guide future models of care.
PMID: 26054052
ISSN: 1097-0142
CID: 2587142

Infertility in reproductive-age female cancer survivors

Levine, Jennifer M; Kelvin, Joanne Frankel; Quinn, Gwendolyn P; Gracia, Clarisa R
Improved survival rates among reproductive-age females diagnosed with cancer have increased the focus on long-term quality of life, including maintenance of the ability to conceive biological children. Cancer-directed therapies such as high-dose alkylating agents and radiation to the pelvis, which deplete ovarian reserve, radiation to the brain, which affects the hypothalamic-pituitary-gonadal axis, and surgical resection of reproductive structures can decrease the likelihood of having biological children. Standard fertility preservation strategies such as embryo and oocyte cryopreservation before the onset of therapy offer the opportunity to conserve fertility, but they may not be feasible because of the urgency to start cancer therapy, financial limitations, and a lack of access to reproductive endocrinologists. Ovarian tissue freezing is considered experimental, with limited data related to pregnancies, but it minimizes treatment delay. Studies evaluating gonadotropin-releasing hormone analogues have had mixed results, although a recent randomized, prospective study in women with breast cancer demonstrated a protective effect. Fertility preservation programs are increasingly being developed within cancer programs. In this article, we describe risks to infertility and options for preservation, raise psychosocial and ethical issues, and propose elements for establishing an effective fertility preservation program.
PMID: 25649243
ISSN: 1097-0142
CID: 2587202

Participatory evaluation of a community-academic partnership to inform capacity-building and sustainability

Simmons, Vani Nath; Klasko, Lynne B; Fleming, Khaliah; Koskan, Alexis M; Jackson, Nia T; Noel-Thomas, Shalewa; Luque, John S; Vadaparampil, Susan T; Lee, Ji-Hyun; Quinn, Gwendolyn P; Britt, Lounell; Waddell, Rhondda; Meade, Cathy D; Gwede, Clement K
The Tampa Bay Community Cancer Network (TBCCN) was formed as a partnership comprised of committed community based organizations (grassroots, service, health care organizations) and a National Cancer Institute designated cancer center working together to reduce cancer health disparities. Adhering to principles of community-based participatory research, TBCCN's primary aims are to develop and sustain outreach, training, and research programs that aim to reach medically underserved, multicultural and multilingual populations within the Tampa Bay tri-county area. Using a participatory evaluation approach, we recently evaluated the partnerships' priorities for cancer education and outreach; perspectives on the partnerships' adherence to CBPR principles; and suggestions for sustaining TBCCN and its efforts. The purpose of this paper is to describe implementation and outcomes of this participatory evaluation of a community/academic partnership, and to illustrate the application of evaluation findings for partnership capacity-building and sustainability. Our evaluation provides evidence for partners' perceived benefits and realized expectations of the partnership and illustrates the value of ongoing and continued partnership assessment to directly inform program activities and build community capacity and sustainability.
PMCID:4509815
PMID: 25863014
ISSN: 1873-7870
CID: 2587152

Quality of life in adolescent and young adult cancer patients: a systematic review of the literature

Quinn, Gwendolyn P; Goncalves, Vania; Sehovic, Ivana; Bowman, Meghan L; Reed, Damon R
INTRODUCTION: Adolescent and young adult (AYA) cancer survivors experience many unique challenges and quality of life (QoL) effects that persist beyond cancer diagnosis and treatment. Due to continuous improvements in technology and cancer treatments resulting in improved survival rates, the identification of late effects, survivorship issues, and QoL is moving to the forefront of cancer research. The goal of this systematic review was to identify key psychosocial factors impacting QoL in AYA oncology populations. METHODS: A systematic review of the literature was conducted using combinations of these phrases or keywords: "adolescent and young adult or AYA" AND "health outcomes OR quality of life OR psychology" AND "neoplasm OR cancer OR oncology". A total of 35 articles were included in this review. Studies were classified into two categories: AYA perceptions and stakeholder perceptions. RESULTS: AYA cancer survivors were more likely to have "worse" or impaired QoL compared with the general population, regardless of other demographic factors. AYAs described both positive and negatives experiences with their medical care, the educational information received, and the supportive care services. Although health care professionals were likely to underestimate or misjudge the health preferences and support needs of AYAs, these perceptions varied across disciplines and levels of experience. CONCLUSION: The literature is lacking in sufficient evidence-based interventions to improve QoL in AYA cancer populations. Further, the tools to adequately measure QoL in this population are also unsatisfactory. The literature, however, consistently shows agreement regarding the unique needs of this population, indicating a trend toward health care standardization within age ranges or life stages. We suggest the need for AYA-specific programs in health care institutions that comprise a multidisciplinary team that addresses all the unique medical and QoL needs of AYAs.
PMCID:4337625
PMID: 25733941
ISSN: 1179-271x
CID: 2587182

Patients' perceptions of colorectal cancer screening tests and preparatory education in federally qualified health centers

Gwede, Clement K; Koskan, Alexis M; Quinn, Gwendolyn P; Davis, Stacy N; Ealey, Jamila; Abdulla, Rania; Vadaparampil, Susan T; Elliott, Gloria; Lopez, Diana; Shibata, David; Roetzheim, Richard G; Meade, Cathy D
This study explored federally qualified health center (FQHC) patients' perceptions about colorectal cancer screening (CRCS) tests, including immunochemical fecal occult blood tests (iFOBT), as well as preferences for receiving in-clinic education about CRCS. Eight mixed gender focus groups were conducted with 53 patients. Findings centered on three thematic factors: (1) motivators and impediments to CRCS, (2) test-specific preferences and receptivity to iFOBTs, and (3) preferences for entertaining and engaging plain language materials. Results informed the development of educational priming materials to increase CRCS using iFOBT in FQHCs.
PMCID:4372499
PMID: 25249181
ISSN: 1543-0154
CID: 2587252

The importance of disclosure: lesbian, gay, bisexual, transgender/transsexual, queer/questioning, and intersex individuals and the cancer continuum

Quinn, Gwendolyn P; Schabath, Matthew B; Sanchez, Julian A; Sutton, Steven K; Green, B Lee
PMCID:4505934
PMID: 25521303
ISSN: 1097-0142
CID: 2587242

Ethical considerations for informed consent in infertility research: The use of electronic health records

Wells, Kristen J; Gordon, Janna R; Su, H Irene; Plosker, Shayne; Quinn, Gwendolyn P
The growing use of electronic health records (EHRs) in healthcare provides rich opportunities for biomedical research. Using EHRs, massive quantities of patient data can be extracted for research without the need to recruit patients, schedule study visits, or rely on self-reporting. However, this innovation poses significant concerns about patient privacy and confidentiality of data. Patients receiving infertility treatment may be particularly vulnerable to data breaches, as their EHRs often include sensitive health information about themselves, their partner, and their offspring. Helping patients with infertility to make informed decisions about sharing data is crucial, yet little is known about best practices for obtaining informed consent to use EHR data for research. This commentary reviews possible options for obtaining informed consent for EHR use among patients seeking fertility services. In addition, this commentary summarizes the limited research available on patient preferences for informed consent practices.
PMCID:4824403
PMID: 27066591
ISSN: 2385-5495
CID: 2587232

Acceptability and Cultural Appropriateness of Self-Help Booklets for Relapse Prevention in Puerto Rico

Menzie, Nicole S; Simmons, Vani N; Quinn, Gwendolyn P; Diaz, Diana B; Pineiro, Barbara; Jimenez, Julio; Castro, Eida; Brandon, Thomas H
Cigarette smoking is associated with a range of cancers and is related to five of seven leading causes of death in Puerto Rico. Minimal self-help interventions have shown promising results in reaching participants and preventing relapse from smoking. Specifically, a collection of eight self-help booklets has demonstrated efficacy (Brandon et al., 2000; 2004). Those booklets have been transcreated into Spanish, with efforts to make them culturally appropriate across a range of Hispanic cultures. We conducted a pilot study in Ponce, Puerto Rico, to evaluate the Spanish version of our smoking relapse-prevention booklets. Qualitative, semi-structured interviews were conducted with 20 current and former smokers. Interviews were conducted to elicit feedback regarding the booklet's content, cultural appropriateness, dissemination, and perceived availability of smoking cessation resources in Puerto Rico. Interviews were audiotaped and transcribed verbatim. Transcripts were coded using content analysis, with a priori codes based on the interview guide. Emergent themes were examined. Overall, participants liked the booklets' content, perceived them to be culturally appropriate, easy to read and understand. Regarding dissemination, it was recommended that the booklets be disseminated by physicians and advertised through television. Most importantly, participants reported the best way to distribute and complement the booklets would be through support groups. Participants also reported having limited knowledge about resources provided in the community to aid smoking cessation. Overall, this pilot study was able to show the cultural acceptability of the booklets and highlights the need for the dissemination of these materials among current and former smokers in Puerto Rico.
PMCID:4384999
PMID: 25219544
ISSN: 1543-0154
CID: 2587262

If you did not document it, it did not happen: rates of documentation of discussion of infertility risk in adolescent and young adult oncology patients' medical records

Quinn, Gwendolyn P; Block, Rebecca G; Clayman, Marla L; Kelvin, Joanne; Arvey, Sarah R; Lee, Ji-Hyun; Reinecke, Joyce; Sehovic, Ivana; Jacobsen, Paul B; Reed, Damon; Gonzalez, Luis; Vadaparampil, Susan T; Laronga, Christine; Lee, M Catherine; Pow-Sang, Julio; Eggly, Susan; Franklin, Anna; Shah, Bijal; Fulp, William J; Hayes-Lattin, Brandon
PURPOSE: The adolescent and young adult (AYA) population is underserved because of unique late-effect issues, particularly future fertility. This study sought to establish rates of documentation of discussion of risk of infertility, fertility preservation (FP) options, and referrals to fertility specialists in AYA patients' medical records at four cancer centers. METHODS: All centers reviewed randomized records within the top four AYA disease sites (breast, leukemia/lymphoma, sarcoma, and testicular). Eligible records included those of patients: diagnosed in 2011, with no prior receipt of gonadotoxic therapy; age 18 to 45 years; with no multiple primary cancers; and for whom record was not second opinion. Quality Oncology Practice Initiative methods were used to evaluate documentation of discussion of risk of infertility, discussion of FP options, and referral to a fertility specialist. RESULTS: Of 231 records, 26% documented infertility risk discussion, 24% documented FP option discussion, and 13% documented referral to a fertility specialist. Records were less likely to contain evidence of infertility risk and FP option discussions for female patients (P = .030 and .004, respectively) and those with breast cancer (P = .021 and < .001, respectively). Records for Hispanic/Latino patients were less likely to contain evidence of infertility risk discussion (P = .037). Records were less likely to document infertility risk discussion, FP option discussion, and fertility specialist referral for patients age >/= 40 years (P < .001, < .001, and .002, respectively) and those who already had children (all P < .001). CONCLUSION: The overall rate of documentation of discussion of FP is low, and results show disparities among specific groups. Although greater numbers of discussions may be occurring, there is a need to create interventions to improve documentation.
PMCID:4799849
PMID: 25549654
ISSN: 1935-469x
CID: 2587222