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Effect of Apoyo con Carino (Support With Caring) Trial of a Patient Navigator Intervention to Improve Palliative Care Outcomes for Latino Adults With Advanced Cancer: A Randomized Clinical Trial.

ABSTRACT: Importance:Strategies to increase access to palliative care, particularly for racial/ethnic minorities, must maximize primary palliative care and community-based models to meet the ever-growing need in a culturally sensitive and congruent manner. Objective:To investigate if a culturally tailored patient navigator intervention can improve palliative care outcomes for Latino adults with advanced cancer. Design, Setting, and Participants:The Apoyo con Cariño (Support With Caring) randomized clinical trial was conducted from July 2012 to March 2016. The setting was clinics across the state of Colorado, including an academic National Cancer Institute-designated cancer center, community cancer clinics (urban and rural), and a safety-net cancer center. Participants were adults who self-identified as Latino and were being treated for advanced cancer. Intervention:Culturally tailored patient navigator intervention. Main Outcomes and Measures:Primary outcome measures were advance care planning in the medical record, the Brief Pain Inventory, and hospice use. Secondary outcome measures included the McGill Quality of Life Questionnaire (MQOL), hospice length of stay, and aggressiveness of care at the end of life. This study used an intent-to-treat design. Results:In total, 223 Latino adults enrolled (mean [SD] age, 58.1 [13.6] years; 55.6% female) and were randomized to control (n?=?111) or intervention (n?=?112) groups. Intervention group patients were more likely to have a documented advance directive compared with control group patients (73 of 112 [65.2%] vs 40 of 111 [36.0%], P?

SUBMITTER: Fischer SM

PROVIDER: S-EPMC6440710 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Effect of Apoyo con Cariño (Support With Caring) Trial of a Patient Navigator Intervention to Improve Palliative Care Outcomes for Latino Adults With Advanced Cancer: A Randomized Clinical Trial.

Fischer Stacy M SM Kline Danielle M DM Min Sung-Joon SJ Okuyama-Sasaki Sonia S Fink Regina M RM

JAMA oncology 20181201 12

<h4>Importance</h4>Strategies to increase access to palliative care, particularly for racial/ethnic minorities, must maximize primary palliative care and community-based models to meet the ever-growing need in a culturally sensitive and congruent manner.<h4>Objective</h4>To investigate if a culturally tailored patient navigator intervention can improve palliative care outcomes for Latino adults with advanced cancer.<h4>Design, setting, and participants</h4>The Apoyo con Cariño (Support With Cari ...[more]

PMID: 30326035

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Project description:ImportanceDespite requirements of informed consent, patients with advanced cancer often receive palliative chemotherapy (PC) without understanding that the likelihood of cure is remote.ObjectiveTo determine whether a PC educational video and booklet at treatment initiation could improve patients' understanding of its benefits and risks.InterventionsRegimen-specific PC videos and booklets presenting information about logistics, potential benefits, life expectancy (optional), adverse effects, and alternatives. Videos featured authentic patients sharing diverse experiences. After receiving treatment recommendations, research assistants distributed materials to patients for independent review.Design, setting, and participantsMulticenter randomized clinical trial of patients with advanced colorectal or pancreatic cancer starting first-line or second-line PC in 5 US cancer centers with enrollment from June 2015 to September 2017 and follow-up to December 2019.Main outcomes and measuresThe primary outcome was accurate expectations of chemotherapy benefits at 3 months, defined as responding "not at all likely" to "What is your understanding of how likely the chemotherapy is to cure your cancer?" (from the Cancer Care Outcomes Research and Surveillance study). Secondary outcomes included understanding of adverse effects, decisional conflict (SURE test), regret (Decisional Regret Scale), and distress (Functional Assessment of Cancer Therapy-General emotional well-being subscale).ResultsAmong 186 patients with advanced colorectal or pancreatic cancer who were starting first-line or second-line PC (94 randomized to usual care, 92 to intervention; mean [SD] age, 59.3 [12.6] [range, 28-86] years; 107 [58%] male; 118 [63.4%] colorectal and 68 [36.6%] pancreatic cancer), most patients wanted "a lot" of information or "as much information as possible" about adverse effects (149, 80.1%), likelihood of cure (148, 79.6%), and prognosis (148, 79.6%). Among the intervention arm, 59 (78%) reviewed the booklet and 30 (40%) reviewed the video within 2 weeks. The primary outcome did not differ between intervention and control arms (52.6%; 95% CI, 40.3%-65.0%; vs 55.5%; 95% CI, 45.1%-66.0%). Accurate adverse effect understanding was more common among intervention than control patients (56.0%; 95% CI, 44.3%-67.7%; vs 40.2%; 95% CI, 29.5%-50.9%; P = .05), although this did not meet the threshold for statistical significance. The intervention did not increase distress, despite frank prognostic information. Other secondary outcomes were similar.Conclusions and relevanceProvision of an educational video and booklet did not alter patients' expectation of cure from PC. Alternative delivery strategies, such as integration with nurse teaching, could be explored in future studies.Trial registrationClinicalTrials.gov Identifier: NCT02282722.

Project description:IntroductionLatino men experience disproportionately high rates of diseases related to low physical activity, yet they are poorly represented in physical activity intervention trials. Efforts to promote physical activity in Latina women show promising results, yet such interventions are yet to be extended to Latino men. This study tested a computer expert system‒tailored, text messaging-supported physical activity intervention for underactive Spanish-speaking Latino men compared with a control group matched for contact time. Potential predictors of intervention success were also explored.Study designRandomized trial. Participants were randomized to receive a Tailored Physical Activity Intervention (Intervention) or a Wellness Control (Control). Data were collected in 2015-2017 and analyzed in 2018-2019.Setting/participantsInsufficiently active Latino men (n=46).InterventionIntervention participants received a baseline counseling session and then, individually tailored print materials and text messages on a tapered schedule for 6 months. Control participants received printed wellness materials and text messages on the same schedule.Main outcome measuresPrimary outcome was a change in weekly moderate to vigorous physical activity from baseline to 6 months measured by accelerometers. Self-reported moderate to vigorous physical activity measured by the 7-day Physical Activity Recall Interview was a secondary outcome.ResultsFor Intervention participants, median accelerometer-measured moderate to vigorous physical activity increased from 10.0 minutes/week at baseline to 57.5 minutes/week at 6 months, whereas for Control participants, it increased from 21.0 minutes/week at baseline to 23.0 minutes/week at 6 months (p<0.05). Similar results were found for self-reported moderate to vigorous physical activity. At 6 months, 47% of Intervention participants met national guidelines of 150 minutes/week versus 25% of Control participants (p=0.15, not significant).ConclusionsFindings suggest that an individually tailored intervention can successfully increase moderate to vigorous physical activity in underactive Latino men. Such technology-supported interventions have the potential for broad dissemination.Trial registrationThis study is registered at www.clinicaltrials.gov NCT02512419.

Project description:Background: Sleep disorders are commonly experienced by community caregivers for persons with cancer, with at least 72% reporting moderate to severe disorders. A consequence of this condition, which is associated with the presence of overload in the caregiver, is the increased risk of clinical depression. The aim of this study is to evaluate the effects of music on the sleep quality achieved by informal caregivers for cancer patients receiving home palliative care. In addition, we will assess the influence of specific variables that could modify these effects, analyse the correlates related to nocturnal wakefulness and consider the diurnal consequences according to the sleep characteristics identified.Methods: This single-blind, multicentre, randomised clinical trial will focus on informal providers of care for cancer patients. Two samples of 40 caregivers will be recruited. The first, intervention, group will receive seven music-based sessions. The control group will be masked with seven sessions of therapeutic education (reinforcing previous sessions). Outcomes will be evaluated using the Pittsburgh Sleep Quality Index, a triaxial accelerometer, EuroQol-5D-5L, the Caregiver Strain Index, the Epworth Sleepiness Scale and the Client Satisfaction Questionnaire. The caregivers' satisfaction with the intervention performed will also be examined.Discussion: This study is expected to extend our understanding of the efficacy of music therapy in enhancing the sleep quality of caregivers for patients receiving home palliative care. To our knowledge, no reliable scientific investigations of this subject have previously been undertaken. Music is believed to benefit certain aspects of sleep, but this has yet to be proven and, according to a Cochrane review, high-quality research in this field is necessary. One of the main strengths of our study, which heightens the quality of the randomised clinical trial design, is the objective assessment of physical activity by accelerometry and the use of both objective and subjective measures of sleep in caregivers. Music therapy for the caregivers addressed in this study is complementary, readily applicable, provokes no harmful side effects and may produce significant benefits.Trial registration: The IMECA study is registered at Clinical Trials.gov, ClinicalTrials.gov Identifier: NCT04491110 . Registered 29 July, 2020.

Project description:There are few randomized controlled trials on the effectiveness of palliative care interventions to improve the care of patients with advanced cancer.To determine the effect of a nursing-led intervention on quality of life, symptom intensity, mood, and resource use in patients with advanced cancer.Randomized controlled trial conducted from November 2003 through May 2008 of 322 patients with advanced cancer in a rural, National Cancer Institute-designated comprehensive cancer center in New Hampshire and affiliated outreach clinics and a VA medical center in Vermont.A multicomponent, psychoeducational intervention (Project ENABLE [Educate, Nurture, Advise, Before Life Ends]) conducted by advanced practice nurses consisting of 4 weekly educational sessions and monthly follow-up sessions until death or study completion (n = 161) vs usual care (n = 161).Quality of life was measured by the Functional Assessment of Chronic Illness Therapy for Palliative Care (score range, 0-184). Symptom intensity was measured by the Edmonton Symptom Assessment Scale (score range, 0-900). Mood was measured by the Center for Epidemiological Studies Depression Scale (range, 0-60). These measures were assessed at baseline, 1 month, and every 3 months until death or study completion. Intensity of service was measured as the number of days in the hospital and in the intensive care unit (ICU) and the number of emergency department visits recorded in the electronic medical record.A total of 322 participants with cancer of the gastrointestinal tract (41%; 67 in the usual care group vs 66 in the intervention group), lung (36%; 58 vs 59), genitourinary tract (12%; 20 vs 19), and breast (10%; 16 vs 17) were randomized. The estimated treatment effects (intervention minus usual care) for all participants were a mean (SE) of 4.6 (2) for quality of life (P = .02), -27.8 (15) for symptom intensity (P = .06), and -1.8 (0.81) for depressed mood (P = .02). The estimated treatment effects in participants who died during the study were a mean (SE) of 8.6 (3.6) for quality of life (P = .02), -24.2 (20.5) for symptom intensity (P = .24), and -2.7 (1.2) for depressed mood (P = .03). Intensity of service did not differ between the 2 groups.Compared with participants receiving usual oncology care, those receiving a nurse-led, palliative care-focused intervention addressing physical, psychosocial, and care coordination provided concurrently with oncology care had higher scores for quality of life and mood, but did not have improvements in symptom intensity scores or reduced days in the hospital or ICU or emergency department visits.clinicaltrials.gov Identifier: NCT00253383.

Dataset Information

Effect of Apoyo con Carino (Support With Caring) Trial of a Patient Navigator Intervention to Improve Palliative Care Outcomes for Latino Adults With Advanced Cancer: A Randomized Clinical Trial.

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Effect of Apoyo con Cariño (Support With Caring) Trial of a Patient Navigator Intervention to Improve Palliative Care Outcomes for Latino Adults With Advanced Cancer: A Randomized Clinical Trial.

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