Quality of care received and patient-reported regret in prostate cancer: Analysis of a population-based prospective cohort.

BACKGROUND: Meeting quality of care standards in oncology is recognized as important by physicians, professional organizations, and payers. Data from a population-based cohort of patients with prostate cancer were used to examine whether receipt of care was consistent with published consensus metrics and whether receiving high-quality care was associated with less patient-reported treatment decisional regret. METHODS: Patients with incident prostate cancer were enrolled in collaboration with the North Carolina Central Cancer Registry, with an oversampling of minority patients. Medical record abstraction was used to determine whether participants received high-quality care based on 5 standards: 1) discussion of all treatment options; 2) complete workup (prostate-specific antigen, Gleason grade, and clinical stage); 3) low-risk participants did not undergo a bone scan; 4) high-risk participants treated with radiotherapy (RT) received androgen deprivation therapy; and 5) participants treated with RT received conformal or intensity-modulated RT. Treatment decisional regret was assessed using a validated instrument. RESULTS: A total of 804 participants were analyzed. Overall, 66% of African American and 73% of white participants received care that met all standards (P = .03); this racial difference was confirmed by multivariable analysis. Care that included "discussion of all treatment options" was found to be associated with less patient-reported regret on univariable analysis (P = .03) and multivariable analysis (odds ratio, 0.59; 95% confidence interval, 0.37-0.95). CONCLUSIONS: The majority of participants received high-quality care, but racial disparity existed. Participants who discussed all treatment options appeared to have less treatment decisional regret. To the authors' knowledge, this is the first study to demonstrate an association between a quality of care metric and patient-reported outcome. Cancer 2017;138-143. © 2016 American Cancer Society.

Living with cancer-related uncertainty: associations with fatigue, insomnia, and affect in younger breast cancer survivors.

PURPOSE: Uncertainty in cancer patients and survivors about cancer-related symptoms, treatment, and disease course has been related to poorer mental and physical health. However, little is known about whether cancer-related uncertainty relates with specific disease and treatment-related outcomes such as fatigue, insomnia, and affect disruptions. In this paper, we report these associations in younger survivors aged 50 years or less, a population increasing in prevalence. METHODS: Participants included 313 breast cancer survivors (117 African-Americans and 196 Caucasians) who were aged 24 to 50 years and were 2 to 4 years posttreatment. Self-reported cancer-related uncertainty (Mishel Uncertainty in Illness Scale-Survivor Version), fatigue (Piper Fatigue Scale-Revised), insomnia (Insomnia Severity Index), and negative and positive affect (Positive and Negative Affect Schedule (PANAS)) measures were collected upon study entry. RESULTS: Hierarchical regression analyses controlled for relevant sociodemographic variables include the following: race, age, years of education, number of children, employment status, marital status, monthly income, smoking status, family history of cancer, endorsement of treatment-induced menopause, and religiosity. Over and above these factors, higher cancer-related uncertainty was significantly associated with more self-reported fatigue (ß = .43), insomnia (ß = .34), negative affect (ß = .43), as well as less positive affect (ß = -.33), all ps < .01. CONCLUSIONS: Younger breast cancer survivors who are 2-4 years posttreatment experience cancer-related uncertainty, with higher levels associated with more self-reported psychophysiological disruptions. Cancer survivors who present in clinical settings with high uncertainty about recurrence or management of long-term effects of treatment may thus benefit from assessment of fatigue, insomnia, and affect.

An intervention to decrease stigma in young adults with sickle cell disease.

Young adults with sickle cell disease (SCD) are often stigmatized when they seek care for pain. The purpose of this pilot study was to test an intervention to decrease health-related stigma during care-seeking. Young adults with SCD ages 18 to 35 years (n = 90) were randomized to either the care-seeking intervention (CSI) or an attention control group that participated in life review interviews. The two groups were compared by t tests and longitudinal data analyses on the change from baseline to the last time point in total health-related stigma and health-related stigma by doctors. Findings suggest that the CSI was associated with significant increased awareness of perceived total stigma and stigma by doctors compared with the attention control group. These findings are promising in terms of lessons learned from a pilot intervention that focused on the role communication skills play in decreasing health-related stigma in young adults with SCD.

Outcomes of an uncertainty management intervention in younger African American and Caucasian breast cancer survivors.

PURPOSE/OBJECTIVES: To determine whether breast cancer survivors (BCSs) who received an uncertainty management intervention, compared to an attention control condition, would have less uncertainty, better uncertainty management, fewer breast cancer-specific concerns, and more positive psychological outcomes. DESIGN: A 2 × 2 randomized block, repeated-measures design, with data collected at baseline and two other points postintervention, as well as a few days before or after either a mammogram or oncologist visit. SETTING: Rural and urban clinical and community settings. SAMPLE: 313 female BCSs aged 50 or younger; 117 African Americans and 196 Caucasians. METHODS: Participants were blocked on ethnicity and randomly assigned to intervention or control. The intervention, consisting of a scripted CD and a guide booklet, was supplemented by four scripted, 20-minute weekly training calls conducted by nurse interventionists. The control group received the four scripted, 20-minute weekly training calls. MAIN RESEARCH VARIABLES: Uncertainty in illness, uncertainty management, breast cancer-specific concerns, and positive psychological outcomes. FINDINGS: BCSs who received the intervention reported reductions in uncertainty and significant improvements in behavioral and cognitive coping strategies to manage uncertainty, self-efficacy, and sexual dysfunction. CONCLUSIONS: The intervention was effective as delivered in managing uncertainties related to being a younger BCS. IMPLICATIONS FOR NURSING: The intervention can realistically be applied in practice because of its efficient and cost-effective nature requiring minimal direct caregiver involvement. The intervention allows survivors who are having a particular survival issue at any given point in time to access information, resources, and management strategies. KNOWLEDGE TRANSLATION: Materials tested in CD and guide booklet format could be translated into online format for survivors to access as issues arise during increasingly lengthy survivorship periods. Materials could be downloaded to a variety of electronic devices, fitting with the information needs and management styles of younger BCSs.

Engaging African American breast cancer survivors in an intervention trial: culture, responsiveness and community.

INTRODUCTION: Younger breast cancer survivors often lead extremely busy lives with multiple demands and responsibilities, making them difficult to recruit into clinical trials. African American women are even more difficult to recruit because of additional historical and cultural barriers. In a randomized clinical trial of an intervention, we successfully used culturally informed, population-specific recruitment and retention strategies to engage younger African-American breast cancer survivors. METHODS: Caucasian and African American breast cancer survivors were recruited from multiple communities and sites. A variety of planned recruitment and retention strategies addressed cultural and population-specific barriers and were guided by three key principals: increasing familiarity with the study in the communities of interest; increasing the availability and accessibility of study information and study participation; and using cultural brokers. RESULTS: Accrual of younger African-American breast cancer survivors increased by 373% in 11 months. The steepest rise in the numbers of African-American women recruited came when all strategies were in place and operating simultaneously. Retention rates were 87% for both Caucasian and African American women. DISCUSSSION/CONCLUSIONS: To successfully recruit busy, younger African American cancer survivors, it is important to use a multifaceted approach, addressing cultural and racial/ethnic barriers to research participation; bridging gaps across cultures and communities; including the role of faith and beliefs in considering research participation; recognizing the demands of different life stages and economic situations and the place of research in the larger picture of peoples' lives. Designs for recruitment and retention need to be broadly conceptualized and specifically applied. IMPLICATIONS FOR CANCER SURVIVORS: For busy cancer survivors, willingness to participate in and complete research participation is enhanced by strategies that address barriers but also acknowledge the many demands on their time by making research familiar, available, accessible and credible.

Predictors and patterns of participant adherence to a cortisol collection protocol.

BACKGROUND: Cortisol, a stress-related hormone, has been measured in many psychoimmunological studies via collection of saliva; however, patterns of participant adherence to protocol procedures are rarely described in the literature. OBJECTIVES: In this paper we examine adherence to a cortisol morning rise collection protocol and explore its associations with demographic predictors and fatigue. METHOD: Participants included 262 breast cancer survivors enrolled in a National Institute of Nursing Research funded longitudinal intervention study (5R01NR010190, M. Mishel, P.I.). Self-reported times of salivary cortisol collection were recorded for each of 12 saliva samples. Adherence was assessed with respect to various demographic factors and fatigue. Participants were categorized as having high, moderate, or low adherence to the saliva collection protocol. RESULTS: Overall, 117 (45%) participants had high adherence to the protocol, 117 (45%) participants had moderate adherence, and 28 (∼11%) participants had low adherence. Tests for proportionality for the polytomous logistic regression indicated that demographic predictors in our model had a similar association with each level of participant adherence. Women who did not adhere to the saliva collection were more likely to be African American (OR .50, CI .29-.88) and to report a high impact of fatigue on their behaviors (OR .88, CI .79-.98). Though other predictors in the model were not statistically significant (working full-time and living with at least one child under 18 years of age), the overall model was significant (χ(2)(4)=17.35, p<.01). DISCUSSION: To our knowledge, this is the first study to examine profiles of participant adherence to a cortisol sampling protocol over multiple timepoints. By conceptualizing adherence as a polytomous outcome, future studies may give us insights into adherence trends in other populations with the aim of promoting adherence and designing more informed saliva collection protocols.

Patients with chronic hepatitis C undergoing watchful waiting: Exploring trajectories of illness uncertainty and fatigue.

We identified trajectories of illness uncertainty in chronic hepatitis C patients and examined their association with fatigue levels during 12 months of disease monitoring without treatment (watchful waiting). Sixty-two men and 63 women completed uncertainty and fatigue measures. Groups were formed by uncertainty scores (high, medium, and low) at baseline. Baseline fatigue levels were higher in the high uncertainty group than in the medium and low groups. Over time, uncertainty levels did not change. Fatigue levels in the low uncertainty group remained constant, increased in the medium, and decreased in the high groups. Findings suggest that uncertainty and fatigue do not remit spontaneously. Being aware of this may help nurses identify those patients needing support for these two concerns.

Evaluation of a conceptual model based on Mishel's theories of uncertainty in illness in a sample of Taiwanese parents of children with cancer: a cross-sectional questionnaire survey.

BACKGROUND: The prognoses of childhood cancers have improved over the last few decades. Nevertheless, parental uncertainty about the absolute cure and possible relapse pervades the entire illness trajectory. Despite illness-related uncertainty is significantly related to psychological distress, continual uncertainty may serve as a catalyst for positive psychological change and personal growth in the context of surviving cancer. OBJECTIVES: The purpose of this study was to examine a conceptual model that depicts coping and growth in Taiwanese parents living with the continual uncertainty about their child's cancer. The conceptual model was guided by Mishel's theories of Uncertainty in Illness. The impact of the child's health status, parents' education level and perceived social support on parental uncertainty was analyzed. The mediating effect of coping as well as the influence of parental uncertainty and parents' perceived social support on growth through uncertainty was incorporated in the model testing. METHODS: This study involved a sample of 205 mothers and 96 fathers of 226 children enrolled in a longitudinal cancer study in Taiwan. This study only analyzed the data collected at baseline. A cross-sectional design was utilized to examine the relationships among proposed variables. Parental uncertainty and growth through uncertainty were measured by the translated questionnaires originally developed by Mishel. Parents' perceived social support and coping were measured by culturally sensitive instruments developed in Taiwan. RESULTS: The full research model and its alternative models fit adequately to the data via structural equation modeling tests. Parental uncertainty and parents' perceived social support were associated with growth through uncertainty which was mediated by coping. Child's health status and parents' perceived social support would significantly predict parental uncertainty. CONCLUSION: This study suggests that parental uncertainty has negative impact on coping strategies such as interacting with family members while these coping strategies may help Taiwanese parents gain growth through uncertainty. Coping strategies of searching for spiritual meaning and increasing religious activities were not significantly influenced by parental uncertainty in this study. The two coping strategies may be relevant to growth through uncertainty due to Taiwanese cultural belief. Moreover, the availability of social support promotes growth through uncertainty by its impact on lowering parental uncertainty and encouraging more coping. The findings indicate that Taiwanese parents may gain growth through uncertainty while experiencing their child's cancer. The research model provides possible guidelines for oncology nurses to deliver more culturally competent health care for Taiwanese parents of children with cancer.

Test of a conceptual model of uncertainty in children and adolescents with cancer.

Despite recognition as a significant stressor in childhood cancer, illness-related uncertainty from the perspective of children remains under-studied. We tested a conceptual model of uncertainty, derived from Mishel's uncertainty in illness theory, in 68 school-aged children and adolescents with cancer. As hypothesized, uncertainty was significantly related to psychological distress, but only one hypothesized antecedent (parental uncertainty) significantly predicted children's uncertainty. An alternative model incorporating antecedent developmental factors (age and illness-specific expertise) explained 21% of the variance in child uncertainty; controlling for stage of treatment, uncertainty was higher in children with shorter time since diagnosis, older age, lower cancer knowledge, and higher parental uncertainty. These findings provide the foundation for further studies to understand children's management of uncertainty and its contribution to psychological adjustment to illness.

Psychometric evaluation of a new instrument to measure uncertainty in children and adolescents with cancer.

BACKGROUND: Although uncertainty has been characterized as a major stressor for children and adolescents with cancer, it has not been studied systematically. OBJECTIVES: The objective of this study was to describe the development and initial psychometric evaluation of a measure of uncertainty in school-aged children and adolescents with cancer. METHODS: Interview data from the first author's qualitative study of uncertainty in children undergoing cancer treatment (Stewart, 2003) were used to generate 22 items for the Uncertainty Scale for Kids (USK), which were evaluated for content validity by expert panels of children with cancer and experienced clinicians (Stewart, Lynn, & Mishel, 2005). Reliability and validity were evaluated in a sample of 72 children aged 8 to 17 years undergoing cancer treatment. RESULTS: The USK items underwent minor revision following input from content validity experts, and all 22 were retained for testing. The USK demonstrated strong reliability (Cronbach's alpha = .94, test-retest r = .64, p = .005), and preliminary evidence for validity was supported by significant associations between USK scores and cancer knowledge, complexity of treatment, and anxiety and depression. Exploratory factor analysis yielded two factors, not knowing how serious the illness is and not knowing what will happen when, which explained 50.4% of the variance. DISCUSSION: The USK, developed from the perspective of children, performed well in the initial application, demonstrating strong reliability and preliminary evidence for construct and discriminant validity. It holds considerable promise for moving the research forward on uncertainty in childhood cancer.

Managing uncertainty about treatment decision making in early stage prostate cancer: a randomized clinical trial.

OBJECTIVE: The purpose of this study was to examine the effects of a theory-based decision-making uncertainty management intervention (DMUMI) providing newly diagnosed prostate cancer patients with information, communication skills and personally designed prompts. METHODS: A randomized clinical trial was conducted using a 3x2 design with intervention and control groups including both Caucasian and African-American men. General linear mixed models were used to compare intervention groups over time. RESULTS: Significant main effects for the treatment groups were found for uncertainty management (cancer knowledge, problem-solving, and patient-provider communication), medical communication competence, number and helpfulness of resources for information, and decisional regret. CONCLUSION: The intervention was effective in uncertainty management for Caucasian and African-American men, specifically in preparing competent patients with improved knowledge, problem-solving skills, information resources, and communication skills. Using the Uncertainty in Illness Theory, specific skills were selected with a focus on the antecedents of uncertainty. PRACTICE IMPLICATIONS: In the treatment decision-making context, patients and supportive others need information about disease, treatment options and side effects but they also need communication skills training prior to the treatment decision consultation.

Uncertainty, symptoms, and quality of life in persons with chronic hepatitis C.

BACKGROUND: Chronic hepatitis C (CHC) is the most common blood-borne infection in the United States, but little is known about illness uncertainty in these patients. OBJECTIVE: The authors examined the constructs of illness uncertainty. METHOD: In this cross-sectional study, Mishel's Uncertainty in Illness Scale was used to examine these constructs (ambiguity, complexity, inconsistency, unpredictability) and their relationships with fatigue, pain, depressive symptoms, comorbidity, and quality of life (QOL) in 126 CHC patients undergoing a watchful-waiting protocol. RESULTS: The Ambiguity subscale had the strongest relationships with depressive symptoms, QOL, and fatigue, and three of the four subscales were significantly correlated with pain. CONCLUSION: The results suggest targets for patient self-management interventions.

Watching, waiting and uncertainty in prostate cancer.

AIM: This study explores the problems and uncertainties of older men, with prostate cancer, who have undergone watchful waiting and the strategies they use to manage their concerns. BACKGROUND: With life expectancy rising, the number of older men with prostate cancer has increased. Nearly 50% of all new prostate cancers are diagnosed in men over 70 years old. For many of these older men, improvements in medical care have increased the likelihood of living for years with prostate cancer. Thus, watchful waiting has been proposed as a reasonable alternative to treatment for older men with localized prostate cancer. METHODS: A qualitative, descriptive design was used for this study. The results from interviews with 10 men who were undergoing watchful waiting for prostate cancer were analysed using the Mishel's Reconceptualized Uncertainty in Illness model. RESULTS: Domains of uncertainty, appraisal of danger and appraisal of opportunity were identified and each was supported by participant's experience. CONCLUSIONS: The results of the study may be used to expand the Uncertainty in Illness model and develop interventions for men undergoing watchful waiting for prostate cancer. RELEVANCE TO CLINICAL PRACTICE: These findings may be used to enhance current nursing interventions for men electing for watchful waiting as an alternative to treatment for prostate cancer, including patient teaching and support services. Future study should examine the role of nurses in managing uncertainty, especially in patient teaching and in the development, implementation and evaluation of interventions to manage uncertainty.

Testing a model of symptoms, communication, uncertainty, and well-being, in older breast cancer survivors.

Among older, long-term breast cancer survivors, symptoms from previous treatment can generate uncertainty about whether they represent co-morbid conditions, recurrence, or normal aging. This uncertainty can result in emotional distress and thoughts of recurrence. Communication with health care providers may help women reduce uncertainty and improve both emotional and cognitive well-being. To assess the influence of symptoms, uncertainty, and communication with providers on well-being, data from 203 Caucasian and African American survivors, 5-9 years post treatment, were tested using structural equation modeling. Symptoms, age, and uncertainty had the strongest influence on well-being, regardless of race. There was an unexpected positive association between patient-provider communication and thoughts of recurrence. Descriptive analysis revealed that 52% of women were unable to achieve their desired decision-making role with health care providers.

Benefits of the uncertainty management intervention for African American and White older breast cancer survivors: 20-month outcomes.

In a 2 x 2 randomized block repeated measure design, this study evaluated the follow-up efficacy of the uncertainty management intervention at 20 months. The sample included 483 recurrence-free women (342 White, 141 African American women; mean age = 64 years) who were 5-9 years posttreatment for breast cancer. Women were randomly assigned to either the intervention or usual care control condition. The intervention was delivered during 4 weekly telephone sessions in which survivors were guided in the use of audiotaped cognitive-behavioral strategies and a self-help manual. Repeated measures MANOVAs evaluating treatment group, ethnic group, and treatment by ethnic interaction effects at 20 months indicated that training in uncertainty management resulted in improvements in cognitive reframing, cancer knowledge, and a variety of coping skills. Importantly, the 20-month outcomes also demonstrated benefits for women in the intervention condition in terms of declines in illness uncertainty and stable effects in personal growth over time.

Evaluating content validity for children's self-report instruments using children as content experts.

BACKGROUND: The development and evaluation of instruments to index cognitive and emotional processes from the perspectives of children is a priority for pediatric nursing research. OBJECTIVE: To describe the procedures used in employing children as content validity experts in the development of a self-report instrument. METHODS: Following published recommendations for moving from qualitative research to quantitative measurement with adults and for maximizing content validity in self-report instruments, six children aged 8-16 years undergoing treatment for cancer constituted the panel of content experts for review of a measure of children's illness-related uncertainty derived from qualitative interviews. Children were provided with an explanation of the project, an explanation of their role as experts, and explicit instructions on how to evaluate the representativeness of individual items and the total scale. RESULTS: Generally, the children performed the review tasks effectively, although two children (ages 8 and 16 years) had initial difficulty in going beyond their own experience when considering the relevance of individual items. Twenty items were deemed acceptable by at least five out of the six children and two additional items were revised based on their input. DISCUSSION: Employing children as content validity experts adds a critical dimension to establishing psychometrically sound measures for studying the processes affecting the health of children and families.

Benefits from an uncertainty management intervention for African-American and Caucasian older long-term breast cancer survivors.

In a randomized controlled design, this study tested the efficacy of a theoretically based uncertainty management intervention delivered to older long-term breast cancer survivors. The sample included 509 recurrence-free women (360 Caucasian, 149 African-American women) with a mean age of 64 years (S.D.=8.9 years) who were 5-9 years post-treated for breast cancer. Women were randomly assigned to either the intervention or usual care control condition. The intervention was delivered during four weekly telephone sessions, in which study nurses guided cancer survivors in the use of audiotaped cognitive-behavioral strategies to manage uncertainty about recurrence, and a self-help manual designed to help women understand and manage long-term treatment side effects and other symptoms. Treatment outcome data on uncertainty management were gathered at pre-intervention and 10-months afterward. Repeated measures MANOVA evaluating treatment group, ethnic group, and treatment by ethnic interaction effects indicated that training in uncertainty management resulted in improvements in cognitive reframing, cancer knowledge, patient-health care provider communication, and a variety of coping skills. Results are discussed in terms of the importance of theory-based interventions for cancer survivors that target triggers of uncertainty about recurrence and in terms of ethnic differences in response to the intervention.

Uncertainty management intervention for older African American and caucasian long-term breast cancer survivors.

The survivor uncertainty management intervention study is a randomized controlled study designed to test the efficacy of an intervention that combines training in audiotaped cognitive behavioral strategies to manage uncertainty about cancer recurrence with a self-help manual designed to help women understand and manage long-term treatment side effects and other symptoms. Specifically, women were taught to recognize their own personal triggers of uncertainty (places, events or surroundings, that bring back memories, feelings, or concerns about breast cancer), and then use coping skills such as relaxation, distraction, and calming self-talk to deal with uncertainty. Also, women were taught to use the manual as a resource for dealing with fatigue, lymphedema, pain and other symptoms. Treatment outcome data (Mishel et al., in press) indicated that the uncertainty management intervention resulted in improvements in cognitive reframing, cancer knowledge, social support, knowledge of symptoms and side effects, and coping skills when compared to a control condition. The purpose of the present paper was to report on the use and helpfulness of the intervention components by the 244 women who were in the intervention. Findings indicated that women regularly used the intervention components to deal with triggers of breast cancer recurrence and long-term treatment side effects and most women found the strategies very helpful.

Uncertainty intervention for watchful waiting in prostate cancer.

Watchful waiting is a reasonable alternative to treatment for some older men with localized prostate cancer, but it inevitably brings uncertainty. This study tested the effectiveness of the watchful waiting intervention (WWI) in helping men cognitively reframe and manage the uncertainty of watchful waiting. Based on Mishel's Reconceptualized Uncertainty in Illness Theory (Image. 1990; 256-262), the WWI was tested with a convenience sample of 41 men. Experimental subjects received 5 weekly intervention calls from a nurse. Control subjects received usual care. Outcomes were new view of life, mood state, quality of life, and cognitive reframing. Repeated measures of analysis of variance were used to test the effectiveness of the WWI. The sample was 86% Caucasian and 14% African American, with an average age of 75.4 years. Intervention subjects were significantly more likely than controls to view their lives in a new light (P = .02) and experience a decrease in confusion (P = .04) following the intervention. Additionally, intervention subjects reported greater improvement in their quality of life than did controls (P = .01) and believed their quality of life in the future would be better than did controls (P = .01). This study's findings document the benefits of the WWI for patients living with uncertainty.

Depression burden, psychological adjustment, and quality of life in women with breast cancer: patterns over time.

The purpose of this study was to examine how level of depression burden influences women's psychological adjustment and quality of life over time and how depression burden interacted with a community-based oncology support program to influence psychological adjustment and life quality. Participants were 169 women who completed a side effects checklist at three data collection points. Women were divided into two groups based on their depression burden scores: 123 women reporting no burden, and 46 women reporting high depression burden. For psychological adjustment, there were significant interaction effects for intervention by time and for intervention by depression burden by time and significant main effects for depression burden. For life quality, there was a significant interaction effect for intervention by time and a significant main effect for depression burden. The findings document the negative impact of depression burden on psychological adjustment and life quality. Oncology support interventions can be effective in reducing this negative impact.