Including the patient voice in the development and implementation of patient-reported outcomes in cancer clinical trials.

CONTEXT: Patient-reported outcomes (PROs) are used in parallel with clinical evidence to inform decisions made by industry, clinicians, regulators, health technology assessment bodies and other health-care decision-makers. In addition, PRO data can also guide shared decision making and individual patient choice. Yet, the quality of many PROs in cancer clinical trials is suboptimal and requires improvement to add value to health care and policy decision making. OBJECTIVE: To show how the integration of the patient and/or patient advocate at all stages of PRO development can help to realize the full potential of PROs. METHODS: We examined the literature to show that the patient voice is often absent from the planning and implementation of PROs in cancer clinical trials. Good practice examples from the literature were combined with guideline recommendations, training or educational resources, and our own experience to create detailed practical steps for the inclusion of patients and/or patient advocates throughout PRO development. RESULTS: Patient or patient advocates can play an active role in shaping PROs that are meaningful to the patient. They can contribute to content, choice of medium and implementation in a way that may support PRO completion and minimize missing data. Patients and their advocates can work to ensure PRO findings are disseminated appropriately in a way that is accessible to patients. CONCLUSION: This practical guidance aims to optimize PRO development and implementation in clinical trials, resulting in robust, relevant data that reflect the patient experience and that support decisions made by all stakeholders involved in research and health care.

Findings from American Indian Needs Assessments.

Because of decreased access and dismal survival rates, strategies need to be developed to increase cancer awareness and facilitate cancer prevention, early detection, and screening activities within American Indian (AI) populations. The purpose of this study was to develop a locally tailored needs assessment to collect cancer prevention, control, and risk factor information and knowledge, attitude, and perceived behavior (hereafter referred to as "needs assessment") data from 500 community members living in 3 geographically diverse settings: the Southeastern USA, the Rocky Mountain region, and the Northern Plains. Needs assessment data helped identify local health priorities and create a pilot cancer prevention and early detection education intervention. There were two versions of common items of the instrument: short (~35 items) and long (55 items), and each partner added items that were recommended by their local AI Advisory Committee. Each partner collaborated with local AI organizations to identify and recruit participants at community venues. During the sessions, facilitators used Power Point® slides and ARS equipment and software to anonymously collect participants' responses. The partners collected needs assessment data from 677 community members over a 4-year period. Cancer education knowledge was low, barriers to accessing timely cancer screening and care services were excessive, tobacco use was excessive, and daily physical activity was insufficient for most participants. ARS was an effective way to collect needs assessment information. During discussions following the data collection, community members requested more cancer education opportunities, access to patient navigation services, and cultural competency training for healthcare providers.

Reality Versus Grant Application Research "Plans".

This article describes the implementation of the American Indian mHealth Smoking Dependence Study focusing on the differences between what was written in the grant application compared to what happened in reality. The study was designed to evaluate a multicomponent intervention involving 256 participants randomly assigned to one of 15 groups. Participants received either a minimal or an intense level of four intervention components: (1) nicotine replacement therapy, (2) precessation counseling, (3) cessation counseling, and (4) mHealth text messaging. The project team met via biweekly webinars as well as one to two in-person meetings per year throughout the study. The project team openly shared progress and challenges and collaborated to find proactive solutions to address challenges as compared to what was planned in the original grant application. The project team used multiple strategies to overcome unanticipated intervention issues: (1) cell phone challenges, (2) making difficult staffing decisions, (3) survey lessons, (4) nicotine replacement therapy, (5) mHealth text messages, (6) motivational interviewing counseling sessions, and (7) use of e-cigarettes. Smoking cessation studies should be designed based on the grant plans. However, on the ground reality issues needed to be addressed to assure the scientific rigor and innovativeness of this study.

Findings from the native navigators and the Cancer Continuum (NNACC) study.

Native Navigators and the Cancer Continuum (NNACC) was a community based participatory research study among Native American Cancer Research Corporation, CO; Inter-Tribal Council of Michigan, MI; Rapid City Regional Hospital's Walking Forward, SD; Great Plains Tribal Chairman's' Health Board, SD; and Muscogee (Creek) Nation, OK. The project goal was to collaborate, refine, expand, and adapt navigator/community education programs to address American Indian communities' and patients' needs across the continuum of cancer care (prevention through end-of-life). The intervention consisted of four to six site-specific education workshop series at all five sites. Each series encompassed 24 h of community education. The Social Ecology Theory guided intervention development; community members from each site helped refine education materials. Following extensive education, Native Patient Navigators (NPNs) implemented the workshops, referred participants to cancer screenings, helped participants access local programs and resources, and assisted those with cancer to access quality cancer care in a timely manner. The intervention was highly successful; 1,964 community participants took part. Participants were primarily American Indians (83 %), female (70 %) and between 18 and 95 years of age. The education programs increased community knowledge by 28 %, facilitated referral to local services, and, through site-specific navigation services, improved access to care for 77 participants diagnosed with cancer during the intervention. Approximately, 90 % of participants evaluated workshop content as useful and 92.3 % said they would recommend the workshop to others. The intervention successfully increased community members' knowledge and raised the visibility of the NPNs in all five sites.

Providing community education: lessons learned from Native Patient Navigators.

Native Navigators and the Cancer Continuum (NNACC) was a community-based participatory research study among five American Indian organizations. The intervention required lay Native Patient Navigators (NPNs) to implement and evaluate community education workshops in their local settings. Community education was a new role for the NPNs and resulted in many lessons learned. NPNs met quarterly from 2008 through 2013 and shared lessons learned with one another and with the administrative team. In July 2012, the NPNs prioritized lessons learned throughout the study that were specific to implementing the education intervention. These were shared to help other navigators who may be including community education within their scope of work. The NPNs identified eight lessons learned that can be divided into three categories: NPN education and training, workshop content and presentation, and workshop logistics and problem-solving. A ninth overarching lesson for the entire NNACC study identified meeting community needs as an avenue for success. This project was successful due to the diligence of the NPNs in understanding their communities' needs and striving to meet them through education workshops. Nine lessons were identified by the NPNs who provided community education through the NNACC project. Most are relevant to all patient navigators, regardless of patient population, who are incorporating public education into navigation services. Due to their intervention and budget implications, many of these lessons also are relevant to those who are developing navigation research.

A New Framework for Co-Creating Telehealth for Cancer Care with the Patient Community.

The increased use of telehealth in cancer care during the coronavirus disease 2019 pandemic has added to our knowledge and experience of the modality with benefits in terms of efficacy, cost, and patient and healthcare professional experience reported. However, telehealth has also been found not to be universally available to all patients with cancer, nor to be appropriate for every healthcare interaction; additionally, not all patients prefer it. Now that coronavirus disease restrictions have essentially ended and an opportunity to re-assess telehealth provision in cancer care presents, we offer a framework that aims to ensure that the needs and preferences of the patient community are included in the development of telehealth provision. Stakeholders in this process include patients, patient advocates, healthcare providers, healthcare services commissioners, managers, and policy makers. The framework outlines how patient advocates can work with other stakeholders as equal partners at all stages of telehealth service development. The patient advocate community has a unique understanding of the patient perspective as well as expertise in healthcare design and delivery. This enables advocates to contribute to shaping telehealth provision, from policy and guideline formulation to patient navigation. Appropriate resources, education and training may be needed for all stakeholders to support the development of an effective telehealth system. Together with other stakeholders, patient advocates can make an important contribution to optimizing appropriate patient-centred telehealth provision in cancer care.

Preliminary lessons learned from the "Native Navigators and the Cancer Continuum" (NNACC).

This community-based participatory research (CBPR) study was based on patient navigation (Navigator) among three original sites: Colorado, Michigan, and South Dakota. During 2010, the study added two sites: the Comanche Nation and the Muscogee (Creek) Nation (Oklahoma). The intervention includes 24-h of a Navigator-implemented cancer education program that addresses the full continuum of cancer care. The partners include agreements with up to two local Native American organizations each year, called Memorandum Native Organizations, who have strong relationships with local American Indians. Family fun events are used to initiate the series of workshops and to collect baseline data and also to wrap up and evaluate the series 3 months following the completion of the workshop series. Evaluation data are collected using an audience response system (ARS) and stored using an online evaluation program. Among the lessons learned to date are: the Institutional Review Board processes required both regional and national approvals and took more than 9 months. All of the workshop slides were missing some components and needed refinements. The specifics for the Memorandum Native Organization deliverables needed more details. The ARS required additional training sessions, but once learned the Navigator use the ARS well. Use of the NACR website for a password-protected page to store all NNACC workshop and training materials was easier to manage than use of other online storage programs. The community interest in taking part in the workshops was greater than what was anticipated. All of the Navigators' skills are improving and all are enjoying working with the community.

Comparison of quality of life between Native and non-Native cancer survivors: Native and non-Native cancer survivors' QOL.

This paper compares quality of life (QOL) outcomes between Native American and non-Native cancer survivors. Native Patient Navigators helped Native cancer patients complete a 114-item QOL survey and access survivorship information available on the NACES website. The survey was modified from Ferrell et. al's QOL measure and assessed the four domains of cancer survivorship: physical, psychological, social, and spiritual. Findings from Native survivors were compared to Ferrell's findings. This is the first time that QOL outcomes have been compared between Native and Non-Native cancer survivors. Natives scored lower for physical and social QOL, the same for psychological QOL, and higher for spiritual QOL in comparison to non-Natives. Overall QOL scores were the same. Although this is the largest sample of Native cancer survivors reported in peer-reviewed manuscripts, these Native survivorship data are based on a self-selected group and it is unknown if the findings are generalizable to others.

Online evaluation programs: benefits and limitations.

Patient navigation programs are increasing throughout the USA, yet some evaluation measures are too vague to determine what and how navigation functions. Through collaborative efforts an online evaluation program was developed. The goal of this evaluation program is to make data entry accurate, simple, and efficient. This comprehensive program includes major components on staff, mentoring, committees, partnerships, grants/studies, products, dissemination, patient navigation, and reports. Pull down menus, radio buttons, and check boxes are incorporated whenever possible. Although the program has limitations, the benefits of having access to current, up-to-date program data 24/7 are worth overcoming the challenges. Of major benefit is the ability of the staff to tailor summary reports to provide anonymous feedback in a timely manner to community partners and participants. The tailored data are useful for the partners to generate summaries for inclusion in new grant applications.

Breast screening navigator programs within three settings that assist underserved women.

Medically underserved women in the Greater Denver Metropolitan Area had low rates of routine repeat mammograms in the latter 1990s. "Increasing Mammography Adherence among Medically Underserved Women" was designed to increase annual rescreening among medically underserved populations living in this area. Four community-based organizations collaborated to implement this 5-year study. A culturally modified navigator model including both face-to-face and telephone formats was used to facilitate mammography for African Americans, Latinas, Native Americans, and poor White women who had not been rescreened in more than 18 months. The navigator-implemented intervention was statistically significant at the 0.05 level for increasing rescreening.

A randomized trial to reduce smoking among American Indians in South Dakota: The walking forward study.

BACKGROUND: Lung cancer is an important public health issue, particularly among American Indians (AIs). The reported decline in tobacco use for most racial/ethnic groups is not observed among AIs. This project was designed to address the research question, "Why don't more Northern Plains American Indians alter tobacco use behaviors known to increase the risk of cancer?" METHODS: Guided by the Theory of Planned Behavior, a multi-component intervention study was implemented. Adult AIs, age 18 years or older and currently smoking, were enrolled. Eligible subjects were randomized to one of 15 groups and exposed to either a MINIMAL or an INTENSE level of 4 intervention components. The intervention was delivered face-to-face or via telephone by Patient Navigators (PN). The primary outcome was self-reported abstinence from smoking verified by carbon monoxide measurement. RESULTS: At 18 months post-quit date, 88% of those who were still in the study were abstinent. This included 6% of all participants who enrolled in the study (14/254) and 13% of those who made it to the quit date (14/108). No intervention groups were found to have significant proportions of participants who were abstinent from smoking at the quit date (visit 5) or primary outcome visit (18 months post-quit date, visit 11), but use of pharmacologic support for abstinence was found to be an effective strategy for individuals who continued participation throughout the study. Those who remained in the study received more visits and were more likely to be abstinent. CONCLUSIONS: Use of NRT increased the odds of not smoking, as assessed at the 18-month follow-up visit, but no other interventions were found to significantly contribute to abstinence from smoking. Although the intervention protocol included numerous points of contact between CRRs and participants (11 visits) loss to follow-up was extensive with only 16/254 remaining enrolled. Additional research is needed to improve understanding of factors that influence enrollment and retention in smoking cessation interventions for AI and other populations.

Sexual assessment in cancer care: concepts, methods, and strategies for success.

OBJECTIVES: To review the literature and provide specific suggestions for assessing and addressing sexual concerns seen in those diagnosed with cancer. DATA SOURCES: Review and research articles, abstracts, books, electronic databases. CONCLUSION: Sexuality and sexual health are integral components of overall health and essential for quality of life. Patients should have the opportunity to discuss their sexual issues and concerns with a qualified health care professional. Knowledgeable, skilled nurses are well-qualified to conduct sexual assessments and to provide options for interventions and referrals. IMPLICATIONS FOR NURSING PRACTICE: To provide quality cancer care, nurses need to be educated about sexual health and to learn the knowledge and skills requisite to a basic discussion and assessment of potential or actual sexual dysfunction in their patients.

Sexual assessment: research and clinical.

It has been well documented that most patients do not volunteer information about sexual problems, and that health care providers should incorporate at least a brief sexual assessment into routine health histories and medical evaluations. While not every nurse can be a sexual counselor, listening to concerns of patient and family, presenting factual information in a nonthreatening manner, managing noncomplex disease and treatment related symptoms, and providing appropriate referrals can be easily incorporated into routine care.

Navigation as an intervention to eliminate disparities in American Indian communities.

OBJECTIVES: To identify the role of patient navigation in decreasing health care disparities through an exemplar of a successful patient navigation program for American Indian populations living in the Northern and Southern Plains of the United States. DATA SOURCES: Published literature and data from the Native Navigators and the Cancer Continuum study. CONCLUSION: Native Patient Navigators successfully collaborated with local American Indian organizations to provide cancer education through a series of 24-hour workshops. These workshops increased community knowledge about cancer, influenced cancer screening behaviors, and increased the visibility and availability of the navigators to provide navigation services. IMPLICATIONS FOR NURSING PRACTICE: Reaching those with health care disparities requires multiple strategies. Collaborating with patient navigators who are embedded within and trusted by their communities helps to bridge the gap between patients and providers, increases adherence to care recommendations, and improves quality of life and survival.

Toward an mHealth Intervention for Smoking Cessation.

The prevalence of tobacco dependence in the United States (US) remains alarming. Invariably, smoke-related health problems are the leading preventable causes of death in the US. Research has shown that a culturally tailored cessation counseling program can help reduce smoking and other tobacco usage. In this paper, we present a mobile health (mHealth) solution that leverages the Short Message Service (SMS) or text messaging feature of mobile devices to motivate behavior change among tobacco users. Our approach implements the Theory of Planned Behavior (TPB) and a phase-based framework. We make contributions to improving previous mHealth intervention approaches by delivering personalized and evidence-based motivational SMS messages to participants. Our proposed solution implements machine learning algorithms that take the participant's demographic profile and previous smoking behavior into account. We discuss our preliminary evaluation of the system against a couple of pseudo-scenarios and our observation of the system's performance.