Caregiver Perspectives on the Benefits, Burdens, and Moral Distress of Participation in Cancer Clinical Trials.

Caregivers often face critical decisions, burdens, and perceived benefits related to a loved one participating in cancer clinical trial (CCTs). The purpose of this analysis was to better understand caregivers' perceptions on the benefits and burdens of participation in cancer clinical trials. Using a qualitative descriptive design, interviews with 20 caregivers of patient-participants from a larger parent study were conducted. Three major themes emerged. The benefits of research participation focused on enhancing the potential for saving a loved one's life, improving quality of life, and holding altruistic intentions. The burden of research participation emphasized a loved one's suffering as well as physical, emotional, logistical, and financial burden to caregivers. Caregiver moral distress highlighted distressing ethical encounters, such as making decisions on research participation and navigating suboptimal care. Understanding caregiver perceptions is an important step in designing future CCTs that minimize burdens and maximize patient and caregiver health and family-centered care.

Experiences of Patients After Withdrawal From Cancer Clinical Trials.

Importance: Cancer clinical trials (CCTs) provide patients an opportunity to receive experimental drugs, tests, and/or procedures that can lead to remission. For some, a CCT may seem like their only option. Little is known about experiences of patient-participants who withdraw or are withdrawn from CCTs. Objective: To examine patient-participants' experiences during withdrawal from CCTs. Design, Setting, and Participants: This qualitative, descriptive study used a semistructured interview designed specifically for it, with open-ended and probing questions. The study took place at a National Cancer Institute-designated comprehensive cancer center affiliated with the University of Pennsylvania. The need for a sample of 20 interviewees was determined by code and meaning saturation (ie, no new themes revealed and identified themes fully elaborated). Interviews were transcribed verbatim and analyzed with a qualitative software program. Data coded with the software were refined into categories reflecting broad themes. A criterion-based sampling approach was used to select a subset of adult patients with cancer who were former CCT participants and who agreed on exit from those CCTs to a later interview about withdrawal experiences. They were contacted one by one by telephone from September 2015 through June 2019 until 20 agreed. Data analysis was completed in October 2020. Main Outcomes and Measures: Themes characterizing patient-participants' perceptions of their withdrawal experiences. Results: Respondents' mean (SD) age was 64.42 (8.49) years; 12 (63.2%) were men. Most respondents were White (18 respondents [94.7%]) and college educated (11 respondents [55.0%]). Cancer stage data were available for 17 participants, 11 of whom (64.7%) had stage IV cancer at CCT enrollment. Thirteen respondents reported withdrawal as a result of disease progression, and 5 withdrew because of adverse effects. Other reasons for withdrawal included acute illness and participant uncertainty about the reason. Analysis of interview data yielded 5 themes: posttrial prognostic awareness, goals of care discussions, emotional coping, burden of adverse effects, and professional trust and support. Subthemes included regrets or hindsight, urgency to start next treatment, and weighing benefits and burdens of treatment. Limited discussions about patient-participants' immediate posttrial care needs left many feeling that there was no clear path forward. Conclusions and Relevance: Patient-participants transitioning from a CCT described feeling intense symptoms and emotions and awareness that their life span was short and options seemed to be limited. Communication that includes attention to posttrial needs is needed throughout the CCT to help patient-participants navigate posttrial steps. Research should focus on components of responsible and ethical CCT transitions, including types and timing of discussions and who should begin these discussions with patient-participants and their families.

Comparison of Skin Biomechanics and Skin Color in Puerto Rican and Non-Puerto Rican Women.

OBJECTIVE: Skin biomechanics are physical properties that protect the body from injury. Little is known about differences in skin biomechanics in racial/ethnic groups and the role of skin color in these differences. The purpose of this study was to determine the relationship between skin biomechanics (viscoelasticity, hydration) and skin color, when controlling for demographic and health-related variables in a sample of Puerto Rican and non-Puerto Rican women. METHODS: We performed a secondary analysis of data from 545 women in a longitudinal, observational study of skin injury in Puerto Rico and the United States. Data included measures of skin viscoelasticity, skin hydration, skin color, demographic, and health related variables. Skin color was measured by spectrophotometry (L* - lightness/darkness, a*- redness/greenness, b* - yellowness/blueness). The sample was 12.5% Puerto Rican, 27.3% non-Puerto Rican Latina, 28.8% Black, 28.6% White, and 2.8% Other. RESULTS: Regression analyses showed that: 1) higher levels of skin viscoelasticity were associated with lower age, higher BMI, and identifying as non-Puerto Rican Latina as compared to Puerto Rican; (all p < .001); and 2) higher levels of hydration were associated with lower L* values, higher health status, lower BMI, and identifying as non-Puerto Rican Latina, White, or Other as compared to Puerto Rican (all p < .05). CONCLUSION: When adjusting for skin color, Puerto Rican women had lower viscoelasticity and hydration as compared to other groups. Puerto Rican women may be at long-term risk for skin alterations, including pressure injury, as they age or become chronically ill.

Understanding rates of genital-anal injury: Role of skin color and skin biomechanics.

PURPOSE: A series of studies suggest that non-Hispanic White women have significantly more injuries than non-Hispanic Black women after sexual assault and consensual sexual intercourse. One explanation for this difference is that the degree of skin protection may vary as skin mechanics and skin pigmentation vary. The aim of the study was to determine the association among genital-anal injury, skin color, skin viscoelasticity and skin hydration in women following consensual sexual intercourse when controlling for age, smoking history, body mass index (BMI), sun exposure, and health status. PROCEDURES: We employed a prospective cohort study design to enroll women 21 years of age or older at two study sites. They underwent two data collection sessions, baseline and follow-up after consensual sexual intercourse. Baseline genital-anal injury identification occurred with a standard forensic examination (direct visualization, nuclear staining with toluidine blue contrast, and colposcopy examination) and measurements of other variables (skin color, skin viscoelasticity, skin hydration, age, smoking history, body mass index [BMI], sun exposure, and health status). Participants were then asked to have consensual sexual intercourse with a male partner of their choice and to return for a second forensic examination for injury detection. Genital-anal injury was regressed on skin color, skin viscoelasticity, skin hydration, age, smoking history, BMI, sun exposure, and health status. FINDINGS: We enrolled 341 participants, 88 non-Hispanic White (25.8%), 54 non-Hispanic Black (15.8%), 190 Hispanic/Latina (55.7), and 9 Other Identities (2.6%). At baseline the genital-anal injury prevalence was 57.77% and at follow-up after consensual sexual intercourse, injury prevalence was 72.73%. External genital injury prevalence was associated with increased L* (lightness) values (Adjusted Odds Ratio [AOR] = 1.98, 95% Confidence Interval [CI] = 1.03, 4.04) and decreased skin elasticity (AOR = 0.96, 95% CI = 0.93, 0.99) at baseline. Increased skin hydration was associated with a significantly higher frequency of external, internal, anal, and total genital-anal injuries (Adjusted Rate Ratio [ARR] > 1.27) at follow-up. Also at the follow-up examination, Hispanic/Latina participants had significantly lower external genital and total genital-anal injury prevalence and frequency as compared to non-Hispanic White participants (AOR < 0.40). CONCLUSIONS: Our findings provide qualified support for the importance of skin color during the forensic examination. Women with lighter skin tones may have skin that is more easily injured than women with darker tones. In contrast, external genital injuries may be more easily identified in women with light as compared to dark skin, a situation that is important in both the health care and criminal justice systems. Additionally, women with decreased viscoelasticity and increased hydration may be more easily injured. These findings support the need to develop forensic procedures that are effective in people across the range of skin colors and to interpret forensic findings considering the innate properties of the skin.

The influence of anogenital injury on women's willingness to engage with the criminal justice process after rape.

Medical-legal-social science research has documented that nongenital and/or anogenital injuries play a significant role throughout the criminal justice system from victims reporting to judges determining the length of a sentence. What remains an open question is whether the documentation of anogenital injury influences women's willingness to engage in the criminal justice system. A sample of women age 21 years and older residing in an urban area were asked about willingness to report to police, file charges, and work with the courts to prosecute after rape. Questions were framed with a qualifying statement about the forensic examination being able to detect injury related to forced sexual intercourse. Results show that women had a high willingness to act if the examination could detect anogenital injury and women with and without a history of forced sexual intercourse had significant differences in their responses to these questions. Implications for health care, criminal justice system, and future research are discussed.