Geriatric Assessment-Driven Intervention (GAIN) on Chemotherapy-Related Toxic Effects in Older Adults With Cancer: A Randomized Clinical Trial.

IMPORTANCE: Although geriatric assessment-driven intervention improves patient-centered outcomes, its influence on chemotherapy-related toxic effects remains unknown. OBJECTIVE: To assess whether specific geriatric assessment-driven intervention (GAIN) can reduce chemotherapy-related toxic effects in older adults with cancer. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial enrolled 613 participants from a National Cancer Institute-designated cancer center between 2015 and 2019. Patients were 65 years and older with a solid malignant neoplasm, were starting a new chemotherapy regimen, and completed a geriatric assessment. Patients were followed up until chemotherapy completion or 6 months after initiation, whichever occurred first. Data analysis was done by intention-to-treat principle. INTERVENTIONS: Patients were randomized (2:1) to either the GAIN (intervention) or standard of care (SOC) arm. In the GAIN arm, a geriatrics-trained multidisciplinary team composed of an oncologist, nurse practitioner, social worker, physical/occupation therapist, nutritionist, and pharmacist reviewed geriatric assessment results and implemented interventions based on prespecified thresholds built into the geriatric assessment's domains. In the SOC arm, geriatric assessment results were sent to treating oncologists for consideration. MAIN OUTCOMES AND MEASURES: The primary outcome was incidence of grade 3 or higher chemotherapy-related toxic effects (graded using National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0). Secondary outcomes included advance directive completion, emergency department visits, unplanned hospitalizations, average length of stay, unplanned hospital readmissions, chemotherapy dose modifications, and early discontinuation. Overall survival analysis was performed up to 12 months after chemotherapy initiation. RESULTS: Among the 605 eligible participants for analysis, median (range) age was 71 (65-91) years, 357 (59.0%) were women, and 432 (71.4%) had stage IV disease. Cancer types included gastrointestinal (202 [33.4%]), breast (136 [22.5%]), lung (97 [16.0%]), genitourinary (91 [15.0%]), gynecologic (54 [8.9%]), and other (25 [4.1%]). Incidence of grade 3 or higher chemotherapy-related toxic effects was 50.5% (95% CI, 45.6% to 55.4%) in the GAIN arm and 60.6% (95% CI, 53.9% to 67.3%) in the SOC arm, resulting in a significant 10.1% reduction (95% CI, -1.5 to -18.2%; P = .02). A significant absolute increase in advance directive completion of 28.4% with GAIN vs 13.3% with SOC (P < .001) was observed. No significant differences were observed in emergency department visits, unplanned hospitalizations, average length of stay, unplanned readmissions, chemotherapy dose modifications or discontinuations, or overall survival. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, integration of multidisciplinary GAIN significantly reduced grade 3 or higher chemotherapy-related toxic effects in older adults with cancer. Implementation of GAIN into oncology clinical practice should be considered among older adults receiving chemotherapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02517034.

A prospective study to validate the functional assessment of cancer therapy (FACT) for epidermal growth factor receptor inhibitor (EGFRI)-induced dermatologic toxicities FACT-EGFRI 18 questionnaire: SWOG S1013.

BACKGROUND: Papulopustular rash is a common class effect of epidermal growth factor receptor inhibitors (EGFRI) that can affect patients' health-related quality of life and cause disruptions to treatment. SWOG S1013 (NCT01416688) is a multi-center study designed to validate the Functional Assessment of Cancer Therapy EGFRI 18 (FACT-EGFRI 18) using 7-items from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 to assess EGFRI-induced skin-related toxicities and their impact on functional status. METHODS: Patients with a diagnosis of colorectal or lung cancer to receive EGFRI therapies for at least 6 weeks were enrolled. Patient self-assessments using the FACT-EGFRI 18 were completed prior to undergoing CTCAE assessment by trained clinicians at baseline, weekly × 6, and then monthly × 3. The psychometric properties of the FACT-EGFRI 14 (skin toxicity items only) and 18 (plus 2 nail and 2 hair items) were established based on criterion validity, known groups validity, internal consistency reliability, and responsiveness to change. RESULTS: Of the 146 registered patients, 124 were evaluable. High Cronbach's alpha (> 0.70) for both FACT-EGFRI 14 and FACT-EGFRI 18 scores across assessment times were observed. Although agreement (i.e. criterion validity) between individual and summary scales of the FACT-EGFRI 18 for assessing skin toxicity was good, agreement with the clinician-reported CTCAE was only fair. The minimal important difference was determined to be 3 points. The results also demonstrated responsiveness to symptom change. DISCUSSION: Based on the results of this multi-center validation study, the FACT-EGFRI 18 patient-reported outcome instrument provided data from the patient's perspective yielding unique information as well as complementing clinician-rated CTCAE grades, especially for the symptoms of pain, pruritus, and paronychia. CONCLUSIONS: Good to excellent psychometric properties for the FACT-EGFRI 18 were demonstrated, supporting further use of this patient-reported outcomes measure. Additional validation with a more diverse group of patients should be conducted.

Reliability, Validity, and Feasibility of a Computer-Based Geriatric Assessment for Older Adults With Cancer.

PURPOSE: The goal of this study was to evaluate the feasibility, reliability, and validity of a computer-based geriatric assessment via two methods of electronic data capture ( SupportScreen and REDCap) compared with paper-and-pencil data capture among older adults with cancer. METHODS: Eligible patients were ≥ 65 years old, had a cancer diagnosis, and were fluent in English. Patients were randomly assigned to one of four arms, in which they completed the geriatric assessment twice: (1) REDCap and paper and pencil in sessions 1 and 2; (2) REDCap in both sessions; (3) SupportScreen and paper and pencil in sessions 1 and 2; and (4) SupportScreen in both sessions. The feasibility, reliability, and validity of the computer-based geriatric assessment compared with paper and pencil were evaluated. RESULTS: The median age of participants (N = 100) was 71 years (range, 65 to 91 years) and the diagnosis was solid tumor (82%) or hematologic malignancy (18%). For session 1, REDCap took significantly longer to complete than paper and pencil (median, 21 minutes [range, 11 to 44 minutes] v median, 15 minutes [range, 9 to 29 minutes], P < .01) or SupportScreen (median, 16 minutes [range, 6 to 38 minutes], P < .01). There were no significant differences in completion times between SupportScreen and paper and pencil ( P = .50). The computer-based geriatric assessment was feasible. Few participants (8%) needed help with completing the geriatric assessment (REDCap, n = 7 and SupportScreen, n = 1), 89% reported that the length was "just right," and 67% preferred the computer-based geriatric assessment to paper and pencil. Test-retest reliability was high (Spearman correlation coefficient ≥ 0.79) for all scales except for social activity. Validity among similar scales was demonstrated. CONCLUSION: Delivering a computer-based geriatric assessment is feasible, reliable, and valid. SupportScreen methodology is preferred to REDCap.

Effectiveness of a clinical intervention to eliminate barriers to pain and fatigue management in oncology.

BACKGROUND: Pain and fatigue are recognized as critical symptoms that impact quality of life (QOL) in cancer, particularly in palliative care settings. Barriers to pain and fatigue relief have been classified into three categories: patient, professional, and system barriers. The overall objective of this study was to test the effects of a clinical intervention on reducing barriers to pain and fatigue management in oncology. METHODS: This longitudinal, three-group, quasi-experimental study was conducted in three phases: phase 1 (usual care), phase 2 (intervention), and phase 3 (dissemination). A sample of 280 patients with breast, lung, colon, or prostate cancers, stage III and IV disease (80%), and a pain and/or fatigue of 4 or more (moderate to severe) were recruited. The intervention group received four educational sessions on pain/fatigue assessment and management, whereas the control group received usual care. Pain and fatigue barriers and patient knowledge were measured at baseline, 1 month, and 3 months post-accrual for all phases. A 3 × 2 repeated measures statistical design was utilized to derive a priori tests of immediate effects (baseline to 1 month) and sustained effects (baseline or 1 month to 3 months) for each major outcome variable, subscale, and/or scale score. RESULTS: There were significant immediate and sustained effects of the intervention on pain and fatigue barriers as well as knowledge. Measurable improvements in QOL were found in physical and psychological well-being only. CONCLUSION: A clinical intervention was effective in reducing patient barriers to pain and fatigue management, increasing patient knowledge regarding pain and fatigue, and is feasible and acceptable to patients.

Reducing patient barriers to pain and fatigue management.

CONTEXT: Pain and fatigue are recognized as critical symptoms that impact the quality of life of cancer patients. The barriers to pain and fatigue relief have been classified into three categories: patient, professional, and system barriers. OBJECTIVES: The overall objective of this trial as to test the effects of the "Passport to Comfort" intervention on reducing barriers to pain and fatigue management for ambulatory care cancer patients. METHODS: This quasi-experimental, comparative study uses a Phase 1 control group of usual care followed sequentially by a Phase 2 intervention group in which educational and system-change efforts were directed toward improved pain and fatigue management. A sample of 187 cancer patients with breast, lung, colon, or prostate cancers, and a pain and/or fatigue rating of 4 or more (moderate to severe), were recruited. Patients in the intervention group received four educational sessions on pain/fatigue assessment and management, whereas patients in the control group received usual care. Pain and fatigue barriers and patient knowledge were measured at baseline, one month, and three months post-accrual. RESULTS: Patients in the intervention group experienced significant improvements in pain and fatigue measures immediately postintervention, and these improvements were sustained over time. CONCLUSION: The "Passport to Comfort" intervention was effective in reducing patient barriers to pain and fatigue management as well as in increasing patient knowledge regarding pain and fatigue. This intervention demonstrates innovation by translating the evidence-based guidelines for pain and fatigue as developed by the National Comprehensive Cancer Network into practice.

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.

Barriers to pain assessment and management in cancer survivorship.

INTRODUCTION: Healthcare providers frequently lack the knowledge and skills to provide optimal pain management for cancer survivors. Scientific evidence and clinical guidelines are lacking in the management of chronic, persistent pain in survivors. The purpose of this article is to describe pain-related issues of cancer survivors using case presentations of selected patients enrolled in a randomized trial to eliminate barriers to pain management. MATERIALS AND METHODS: Case presentations were selected from a National Cancer Institute-funded study that utilizes patient and professional educational content derived from the clinical guidelines of the National Comprehensive Cancer Network. Case presentation criteria included a pain rating of >or=6 and diagnosis of Stage I, II, or III of the following cancers: breast, colon, lung, or prostate cancer. Cases are presented based on the study's framework of patient, professional, and system-related barriers to optimal pain relief. RESULTS: Across all three case presentations, barriers such as fear of side effects from pain medications, fear of addiction, lack of professional knowledge of the basic principles of pain management, and lack of timely access to pain medications due to reimbursement issues are prevalent in cancer survivorship. CONCLUSIONS: Chronic pain syndromes related to cancer treatments are common in cancer survivors. Patient, professional, and system-related barriers that are seen during active treatment continue to hinder optimal pain relief during survivorship. IMPLICATIONS FOR CANCER SURVIVORS: Healthcare providers must acknowledge the impact of chronic, persistent pain on the quality of cancer survivorship. Clinical as well as scientific efforts to increase knowledge in chronic pain management will improve the symptom management of cancer survivors.

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.