Spirituality in cancer patients on phase 1 clinical trials.

OBJECTIVES: Patients with cancer who are at a transition to Phase I investigational treatments have been identified as an underserved population with regard to palliative care. This disease transition is often accompanied by spiritual and existential concerns. The study objective was to conduct a secondary analysis of data from a larger study testing a palliative care intervention. This paper reports the findings of this secondary focus on the spiritual needs of this population. METHODS: Patients (n = 479) were accrued to this study prior to initiating a Phase I clinical trial with data collected at baseline, and 4, 12, and 24 week follow-up. RESULTS: Qualitative data revealed that the transition to Phase 1 trial participation is a time of balancing hope for extended life with the reality of advancing disease. Quantitative results demonstrated increased spirituality over time in both religious- and non-religious-affiliated patients. CONCLUSIONS: Patients entering Phase I trials have important spiritual needs as they face treatment decisions, advancing disease, and often mortality. Spiritual care should be provided to seriously ill patients as a component of quality care.

Palliative care and spiritual well-being in lung cancer patients and family caregivers.

BACKGROUND: Spiritual well-being is an important dimension of quality of life (QOL) and is a core component of quality oncology and palliative care. In this analysis, we aimed to describe spiritual well-being outcomes in a National Cancer Institute (NCI)-supported Program Project that tested the effectiveness of an interdisciplinary palliative care intervention in lung cancer patients and their family caregivers (FCGs). METHODS: Patients undergoing treatments for NSCLC and their FCGs were enrolled in a prospective, quasi-experimental study. Patients and FCGs in the intervention group were presented at interdisciplinary care meetings and received four educational sessions that included one session focused on spiritual well-being. Spiritual well-being for patients was measured using the FACIT-Sp-12, and FCG spiritual well-being was measured using the COH-QOL-FCG spiritual well-being subscale. Multivariate analysis of covariance was undertaken for subscale and item scores at 12 weeks, controlling for baseline, by religious affiliations (yes or no) and group assignment. RESULTS: Religiously affiliated patients reported better scores in the Faith subscale and items on finding strength and comfort in faith and spiritual beliefs compared to non-affiliated patients. Non-affiliated patients had better scores for feeling a sense of harmony within oneself. By group, patients who received the intervention had significantly better scores for the Meaning/Peace subscale. CONCLUSIONS: Our findings support the multidimensionality of spiritual well-being that includes constructs such as meaning and faith for lung cancer patients and FCGs with or without religious affiliations. Palliative care interventions should include content that targets the spiritual needs of both patients and FCGs. Copyright © 2015 John Wiley & Sons, Ltd.

Death awareness, feelings of uncertainty, and hope in advanced lung cancer patients: can they coexist?

Patients diagnosed with stage-IV lung cancer are forced to quickly transition from a cancer-free and perhaps healthy life to one of serious illness, uncertainty, and anticipation of a premature death. Health professionals may be too quick to label the patient as being in denial if they hope for healing. Hope may not be lost when reality is accepted. Studies have investigated what it is like to live with awareness of impending death. Using a patient case study this paper discusses the concepts of death awareness, uncertainty, and hope. The aim is to provide a deeper understanding of how these seemingly antithetical emotions can coexist to the benefit of the patient, and to provide clinicians with practical considerations for supporting patients' hope throughout their terminal illness.

Palliative Care in the New Era of Lung Cancer Treatment.

Lung cancer remains the most common malignancy and is recognized as having significant impact on quality of life. Advances in lung cancer treatment over the past decade have been significant, with new agents extending life, even in late-stage disease. The purpose of this study was to evaluate palliative care needs and use of supportive care services in a randomly selected sample (N = 99) of patients with lung cancer. Results indicated that despite treatment advances, these patients continue to have significant symptom and quality of life concerns and to receive limited palliative care or supportive care services. Integration of palliative care is needed in the new era of lung cancer treatment.

Care Processes and Quality-of-Life Outcomes Affecting the Gynecologic Cancer Survivorship Experience.

PURPOSE: To describe and assess physical and psychosocial concerns and care processes related to cancer and treatment in gynecologic cancer survivors. PARTICIPANTS & SETTING: 44 survivors of gynecologic cancer at City of Hope National Medical Center in southern California were enrolled. METHODOLOGIC APPROACH: A descriptive mixed-methods approach was used. Data were collected on survivorship care plan implementation, supportive care referrals, and barriers to receiving care. Participants completed questionnaires assessing quality of life, unmet needs, and other outcomes at three, six, and nine months after enrollment. Changes over time were analyzed, and quantitative and qualitative results were compared. FINDINGS: The most common unmet needs were stress reduction, side effect management, fear of cancer recurrence (FCR), and perception of adequate communication among the care team. Qualitative themes centered around communication, care coordination, FCR, financial distress, and need for information about peer support and healthy lifestyles. IMPLICATIONS FOR NURSING: Nurses play a key role in coordinating care, assessing symptoms, and addressing psychosocial concerns. Providing education and coaching can reduce stress and facilitate survivors' self-management and self-efficacy.

Family Caregiver Preparedness: Developing an Educational Intervention for Symptom Management.

BACKGROUND: Family caregivers provide complex care for patients with cancer, including management of multiple symptoms associated with the disease and its treatment. OBJECTIVES: The objective of this pilot project was to develop and conduct feasibility testing of a family caregiver educational intervention for symptom management. METHODS: The intervention was conducted with 23 family caregivers of patients with lung or gynecologic cancer to evaluate feasibility testing and assessment of caregiver preparedness, quality of life, and psychological distress at baseline and three and seven weeks postintervention. FINDINGS: Family caregivers were very interested in education related to their role in symptom management, with management of constipation, dyspnea, and diarrhea as the highest priorities. The intervention was feasible and valuable in assisting family caregivers in assessing symptoms and making decisions regarding treatment choices.

Implementing quality improvement efforts in spiritual care: outcomes from the interprofessional spiritual care education curriculum.

The Interprofessional Spiritual Care Curriculum (ISPEC) was created to train interdisciplinary health care teams to recognize and address the spiritual needs of seriously or chronically ill patients. The curriculum, in a train-the-trainer format, employs didactic presentations, discussions, lab sessions, skill demonstrations, and video clips. In course applications, participants were required to submit goals to achieve and demonstrate institutional support. For the first ISPEC course, in July 2018, 48 clinician-chaplain teams attended. Following the 2½ day course, participants had access to online training modules for 1-year, ISPEC faculty mentoring support, and regular conference calls on goal implementation progress. Participants reported recognizing the importance of providing spiritual care and a new understanding of how collaborating as interprofessional teams enabled them to integrate this care into their home institution settings. In a mixed-methods evaluation survey completed 12 months after the ISPEC course, participants reported on the percentage of their goals completed, number and types of professionals they had educated in spiritual care, and personal confidence regarding spiritual care leadership skills. This data can serve as a model to guide other organizations striving to improve spiritual care, practiced collaboratively by clinicians and chaplains, as an essential aspect of overall QI efforts in palliative care.

Integrating Palliative Care for Patients on Clinical Trials: Opportunities for Oncology Nurses.

The purpose of this article is to describe the lessons learned in the course of a 5-year research study on a palliative care intervention for persons on a Phase 1 clinical trial. Patients who are participating in Phase 1 trials and the families who care for them may be especially vulnerable and require special attention. The patients are generally experiencing the effects of advanced disease, and they also may soon experience unknown side effects, intense treatment regimens, and the emotional stress of an uncertain future as a result of clinical trial participation. Oncology nurses in all roles including clinical trials/research nurses, clinicians, educators, and advanced practice registered nurses play a critical role in addressing the quality-of-life concerns in this population. Palliative care can provide better symptom control and information on treatment options and facilitate a better understanding of patient/family goals. Attending to these factors can ultimately mean improved survival for the advanced cancer patient, and support for these patients can assist in advancing the field of oncology as these investigational therapies hold the promise for enhancing survival.

Fear of Cancer Progression: Findings From Case Studies and a Nurse-Led Intervention.

BACKGROUND: Fear of cancer recurrence or progression (FOP) is a significant concern for cancer survivors. With the advent of new targeted therapies and immunotherapy, many patients with advanced cancer are living longer while dealing with uncertainty and fears related to cancer progression. Although some level of FOP is normal and adaptive, high levels adversely affect quality of life and healthcare costs. OBJECTIVES: This article describes a nurse-led intervention for managing FOP in two patients with advanced gynecologic cancer. The intervention teaches skills for managing worry, challenging unhelpful beliefs, and modifying unhelpful coping behaviors. METHODS: Preliminary findings from the two case studies are presented, including a comparison of post-treatment FOP scores to baseline scores. FINDINGS: The participants reported feeling more focused, less overwhelmed, and more in control of their worries. Both participants achieved statistically reliable improvements in FOP scores.

A nurse-led intervention for fear of cancer progression in advanced cancer: A pilot feasibility study.

PURPOSE: To assess the feasibility, acceptability, and preliminary effects of a nurse-led intervention for managing fear of cancer progression in advanced cancer patients. METHODS: A single group mixed methods study was conducted in patients with stage III or IV gynecologic or lung cancer (n = 31) with dysfunctional levels of fear of progression or distress. The intervention consisted of seven videoconferencing sessions with skills practice. Feasibility measures included enrollment rate, attendance, attrition, and home practice adherence. Acceptability was based on exit interview responses. Content analysis was used to analyze the qualitative data. Participants completed quantitative questionnaires assessing fear of progression and secondary outcomes at baseline, eight, and 12 weeks. Linear mixed model analysis was used to assess changes in outcome measures. RESULTS: The average enrollment rate was seven participants/month over 4.5 months. Participants attended a mean of 5.3 of seven sessions. Attrition rate was 30%. The analysis showed improvements over time in fear of progression and exploratory outcomes. Participants reported feeling calmer and more focused. The skills practice helped to manage anxiety and fears. Themes included: Struggling with fears, Refocusing the fears, and Realizing/reaffirming what is important in life. The most beneficial components included the values clarification exercise, detached mindfulness and worry postponement practices. CONCLUSION: The intervention was acceptable; most feasibility criteria were met. Preliminary data suggest that the intervention reduced fear of progression and improved secondary outcomes. The intervention required a significant time commitment by participants, which may have contributed to increased attrition. To decrease burden, we will shorten the intervention.

Pain and Suffering.

OBJECTIVE: To review literature on the relationship of pain, spirituality, and suffering as it relates to the patient with cancer who is experiencing pain. DATA SOURCES: Peer-reviewed articles, textbooks, internet. CONCLUSION: Pain and suffering are distinct and yet closely related in patients with cancer. Oncology nurses are important in assessing a patient's pain, including dimensions of spirituality and suffering. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses are the front line of pain management for patients. This includes recognizing existential distress and suffering and responding to suffering.

Clinical Trials: Understanding Patient Perspectives and Beliefs About Treatment.

BACKGROUND: Understanding the experiences of patients with solid tumors who are in phase 1 clinical trials can help nurses to provide optimal care. OBJECTIVES: The purpose of this article is to describe patient perspectives of participating in a phase 1 trial and understanding their disease status and treatment options. In addition, the authors describe the impact of the disease and clinical trial participation on quality of life. METHODS: 30 patients were interviewed and audio recorded; the interviews were transcribed and content analysis methods were used to identify common themes. FINDINGS: Patients reported participating in the phase 1 clinical trial because their doctors informed and encouraged them, they had no other treatment options if they wanted to live longer, or they wanted to help future patients with cancer. Most believed that participation would improve or stabilize their illness and quality of life. They believed that, when the clinical trial ended, there would be new treatments. Participants reported that healthcare providers and family members provided support, and that compassion, cultural awareness, spiritual support, and the need for individual attention were important.

A Support Intervention for Family Caregivers of Advanced Cancer Patients.

Family caregivers are the primary providers of care. Education and support are needed to prepare them for the complex physical, psychological, social, and spiritual effects of cancer. This randomized clinical trial tested a palliative care intervention with 240 family caregivers, focusing on family caregivers who reported financial strain from cancer and treatment. A four-part educational program demonstrated improved outcomes in the intervention group in the measures of objective burden, caregiving preparation, and quality of life. The role of advanced practitioners in providing tailored psychoeducation and support to caregivers is important in order to meet the integral needs of patients with cancer as well as to enhance caregiver self-care.

An interdisciplinary care approach for integration of palliative care in lung cancer.

PURPOSE: Quality of Life (QOL) and symptom concerns are common in lung cancer. This article presents findings from 2 separate pilot studies that utilize an educational model to reduce barriers to pain and fatigue management ("barriers study") and an interdisciplinary palliative care approach to manage QOL concerns for patients with lung cancer ("QOL pilot"). PATIENTS AND METHODS: In the barriers study, a total of 46 patients with lung cancer with a self-reported pain and/or fatigue rating of >or=4 were accrued, with 18 patients in the usual care group and 28 in the experimental group, using a quasi-experimental design. This study involved a 4-part educational intervention delivered by a nurse to address pain and fatigue. In the QOL study, the pilot intervention included 10 patients with lung cancer. This pilot included use of QOL assessment completed by a nurse followed by an interdisciplinary case conference intended to initiate supportive care to address QOL and symptom concerns. Patient-reported outcomes such as barriers to pain and fatigue management, fatigue intensity, other symptoms, and overall QOL were analyzed through tabulation of standard summary statistics and multivariate analysis methods. All eligible patients were recruited from the ambulatory clinic of one National Cancer Institute-designated Comprehensive Cancer Center. RESULTS: For the barriers study, patients with lung cancer in the experimental group had a statistically significant decrease in patient-related barriers for both pain and fatigue. Findings from the QOL pilot revealed that patients with lung cancer have multiple QOL concerns and that an interdisciplinary palliative care approach was feasible to address these complex, multidimensional patient needs. CONCLUSION: Attention to barriers of symptom management, early referral to supportive care services, and coordination of interdisciplinary care are essential to supporting the QOL of patients with lung cancer. The next phase of this research will test QOL/symptom interventions for patients with lung cancer.

Cancer-related fatigue: role of oncology nurses in translating National Comprehensive Cancer Network assessment guidelines into practice.

This article reviews the National Comprehensive Cancer Network's (NCCN's) guidelines for cancer-related fatigue (CRF) assessment and discusses many of the common barriers that hinder the translation of the CRF guidelines into practice settings. Current assessment and measurement scales validated in patients with cancer are highlighted, and case studies reflect the vital roles that oncology nurses can play in managing patients with CRF. Oncology nurses must remember to assess the "gang of 7" (i.e., anemia, pain, sleep difficulties, nutrition issues, deconditioning or changes in activity patterns, emotional distress [depression or anxiety], and presence of comorbidities) that may affect workup, treatment, and supportive care referrals. Teaching patients about the importance of viewing CRF as the "sixth vital sign" can emphasize this symptom's importance and significance. Oncology nurses also can recognize the many patient-, provider- and system-related barriers that exist and work with others in a systematic and collaborative fashion within the system to decrease these barriers and begin to incorporate a simple intensity scale for CRF assessment and screening, documentation, and ongoing monitoring. By using available resources, oncology nurses can play significant roles in the translation of the NCCN's evidence-based practice guidelines for CRF in their practice settings.

Family Caregivers: A Qualitative Study to Better Understand the Quality-of-Life Concerns and Needs of This Population.

BACKGROUND: While providing physical, psychological, and spiritual care to their loved ones with cancer, family caregivers (FCGs) are physically and emotionally vulnerable to the tolls of caregiving. Patients and FCGs experience the uncertainty that comes with illness and treatment, its side effects, the lack of control, the emotional upheaval, the spiritual doubt, and the helplessness of advancing disease. OBJECTIVES: This study was conducted to better understand the quality-of-life needs of the FCG population, particularly those who encounter financial strain related to patients' cancer and treatment. METHODS: This qualitative study of FCG concerns was conducted in association with a randomized trial of an FCG support intervention. Twenty FCGs of patients with solid tumor cancers were interviewed in person or via telephone for this study. The FCG version of the City of Hope quality-of-life tool, which consists of four domains of well-being (physical, psychological, social, spiritual), was applied to the content analysis of interviews. FINDINGS: Care for FCGs is needed across all quality-of-life domains.

Translation and Evaluation of a Lung Cancer, Palliative Care Intervention for Community Practice.

CONTEXT: A notable gap in the evidence base for palliative care (PC) for cancer is that most trials were conducted in specialized centers with limited translation and further evaluation in "real-world" settings. Health systems are desperate for guidance on effective, scalable models. OBJECTIVES: The objective of this study was to determine the effects of a nurse-led PC intervention for patients with non-small-cell lung cancer and their family caregivers (FCGs) in a community-based setting. METHODS: Two-group, sequential, quasi-experimental design with Phase 1 (usual care [UC]) followed by Phase 2 (intervention) was conducted at three Kaiser Permanente Southern California sites. Participants included patients with Stage 2-4 non-small-cell lung cancer and their FCG. Standard measures of quality of life (QOL) included Functional Assessment of Cancer Therapy-Lung, Functional Assessment of Chronic Illness Therapy-Spirituality Subscale, City of Hope Family QOL; other outcomes were distress, health care utilization, caregiver preparedness, and burden. RESULTS: Patients in the intervention cohort had significant improvements in three (physical, emotional, and functional well-being) of the five QOL domains at one month that were sustained through three month compared to UC (P < 0.01). Caregivers in the intervention cohort had improvements in physical (P = 0.04) and spiritual well-being (P = 0.03) and preparedness (P = 0.04) compared to UC. There were no differences in distress or health care utilization between cohorts. CONCLUSION: Our findings suggest that a research-based PC intervention can be successfully adapted to community settings to achieve similar, if not better, QOL outcomes for patients and FCGs compared to UC. Nonetheless, additional modifications to ensure consistent referrals to PC and streamlining routine assessments and patient/FCG education are needed to sustain and disseminate the PC intervention.

Overcoming barriers to cancer pain management: an institutional change model.

The Agency for Health Care Policy and Research Pain Guidelines of 1994 recognized pain as a critical symptom that impacts quality of life (QOL). The barriers to optimum pain relief were classified into three categories: patient, professional, and system barriers. A prospective, longitudinal clinical trial is underway to test the effects of the "Passport to Comfort" innovative intervention on pain and fatigue management. This article reports on preintervention findings related to barriers to pain management. Cancer patients with a diagnosis of breast, lung, colon, or prostate cancer who reported a pain rating of >/=4 were accrued. Subjects completed questionnaires to assess subjective ratings of overall QOL, barriers to pain management, and pain knowledge at baseline and at one- and three-month evaluations. A chart audit was conducted at one month to document objective data related to pain management. The majority of subjects had moderate (4-6 on a 0-10 numeric rating scale) pain at the time of accrual. Patient barriers to pain management existed in attitudes and knowledge regarding addiction, tolerance, and not being able to control pain. Subjects who were currently receiving chemotherapy were reluctant to communicate their pain with health care professionals. Professional and system barriers were focused around screening, documentation, reassessment, and follow-up of pain. Lack of referrals to supportive care services for patients was also noted. Several well-described patient, professional, and system barriers continue to hinder efforts to provide optimal pain relief. Phase II of this initiative will attempt to eliminate these barriers using the "Passport" intervention to manage cancer pain.

The oncology nurse's role in the informed consent process.

Cancer clinical trials are a necessary component of the effort to improve cancer prevention, diagnosis, and treatment. Essential to this process is the informed consent of the individuals who participate in these research studies. The purpose of this article is to describe patient, provider, and informed consent process issues with presentations of data reported in the current literature. The role of nursing in the facilitation of informed consent is discussed.