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      Leveraging Smart Health Technology to Empower Patients and Family Caregivers in Managing Cancer Pain: Protocol for a Feasibility Study


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          An estimated 60%-90% of patients with cancer experience moderate to severe pain. Poorly managed cancer pain negatively affects the quality of life for both patients and their family caregivers and can be a particularly challenging symptom to manage at home. Mobile and wireless technology (“Smart Health”) has significant potential to support patients with cancer and their family caregivers and empower them to safely and effectively manage cancer pain.


          This study will deploy a package of sensing technologies, known as Behavioral and Environmental Sensing and Intervention for Cancer (BESI-C), and evaluate its feasibility and acceptability among patients with cancer-family caregiver dyads. Our primary aims are to explore the ability of BESI-C to reliably measure and describe variables relevant to cancer pain in the home setting and to better understand the dyadic effect of pain between patients and family caregivers. A secondary objective is to explore how to best share collected data among key stakeholders (patients, caregivers, and health care providers).


          This descriptive two-year pilot study will include dyads of patients with advanced cancer and their primary family caregivers recruited from an academic medical center outpatient palliative care clinic. Physiological (eg, heart rate, activity) and room-level environmental variables (ambient temperature, humidity, barometric pressure, light, and noise) will be continuously monitored and collected. Behavioral and experiential variables will be actively collected when the caregiver or patient interacts with the custom BESI-C app on their respective smart watch to mark and describe pain events and answer brief, daily ecological momentary assessment surveys. Preliminary analysis will explore the ability of the sensing modalities to infer and detect pain events. Feasibility will be assessed by logistic barriers related to in-home deployment, technical failures related to data capture and fidelity, smart watch wearability issues, and patient recruitment and attrition rates. Acceptability will be measured by dyad perceptions and receptivity to BESI-C through a brief, structured interview and surveys conducted at deployment completion. We will also review summaries of dyad data with participants and health care providers to seek their input regarding data display and content.


          Recruitment began in July 2019 and is in progress. We anticipate the preliminary results to be available by summer 2021.


          BESI-C has significant potential to monitor and predict pain while concurrently enhancing communication, self-efficacy, safety, and quality of life for patients and family caregivers coping with serious illness such as cancer. This exploratory research offers a novel approach to deliver personalized symptom management strategies, improve patient and caregiver outcomes, and reduce disparities in access to pain management and palliative care services.

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          Most cited references39

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          Ecological momentary assessment.

          Assessment in clinical psychology typically relies on global retrospective self-reports collected at research or clinic visits, which are limited by recall bias and are not well suited to address how behavior changes over time and across contexts. Ecological momentary assessment (EMA) involves repeated sampling of subjects' current behaviors and experiences in real time, in subjects' natural environments. EMA aims to minimize recall bias, maximize ecological validity, and allow study of microprocesses that influence behavior in real-world contexts. EMA studies assess particular events in subjects' lives or assess subjects at periodic intervals, often by random time sampling, using technologies ranging from written diaries and telephones to electronic diaries and physiological sensors. We discuss the rationale for EMA, EMA designs, methodological and practical issues, and comparisons of EMA and recall data. EMA holds unique promise to advance the science and practice of clinical psychology by shedding light on the dynamics of behavior in real-world settings.
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            Review of the literature on the effects of caring for a patient with cancer.

            To adequately help family caregivers (FCs) of cancer patients, clinicians need to understand the complexity of the problems and responsibilities associated with cancer patients illness that FCs experience. This systematic review identified the types of problems and burdens that FCs of cancer patients experience during the patient's illness. We also analyzed the language caregivers use to communicate their problems and responsibilities related to caregiving for the cancer patient. Of 2845 titles identified, 192 articles met the inclusion criteria and are included in this review. Of these, 164 were research-based. In addition to FC responsibilities and the impact of being a caregiver on daily life, a number of other physical, social, and emotional problems related to caregiving for these FCs were identified. A substantial evidence base supports the conclusion that FCs experience many difficult problems and increased responsibilities during and after the patient is undergoing treatment and rehabilitation for cancer. The insights gained from this review will help researchers and clinicians to understand the complexity of problems and responsibilities FCs experience. This understanding may encourage them to include support for FCs as part of total or holistic patient care. However, more research is needed to better understand the variations in caregiving experiences over time; how the caregiving perspective is influenced by different cultural, ethnic, or socioeconomic backgrounds as well as gender and age; and how problems and responsibilities related to caregiving interfere with daily life. Copyright © 2009 John Wiley & Sons, Ltd.
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              Interventions with family caregivers of cancer patients: meta-analysis of randomized trials.

              Family caregivers of cancer patients receive little preparation, information, or support to perform their caregiving role. However, their psychosocial needs must be addressed so they can maintain their own health and provide the best possible care to the patient. The purpose of this article is to analyze the types of interventions offered to family caregivers of cancer patients, and to determine the effect of these interventions on various caregiver outcomes. Meta-analysis was used to analyze data obtained from 29 randomized clinical trials published from 1983 through March 2009. Three types of interventions were offered to caregivers: psychoeducational, skills training, and therapeutic counseling. Most interventions were delivered jointly to patients and caregivers, but they varied considerably with regard to dose and duration. The majority of caregivers were female (64%) and Caucasian (84%), and ranged in age from 18 to 92 years (mean age, 55 years). Meta-analysis indicated that although these interventions had small to medium effects, they significantly reduced caregiver burden, improved caregivers' ability to cope, increased their self-efficacy, and improved aspects of their quality of life. Various intervention characteristics were also examined as potential moderators. Clinicians need to deliver research-tested interventions to help caregivers and patients cope effectively and maintain their quality of life. Copyright 2010 American Cancer Society, Inc.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                December 2019
                9 December 2019
                : 8
                : 12
                : e16178
                [1 ] University of Virginia School of Nursing Charlottesville, VA United States
                [2 ] University of Virginia School of Engineering & Applied Science Charlottesville, VA United States
                [3 ] Virginia Commonwealth University Health Richmond, VA United States
                [4 ] University of Virginia School of Medicine Charlottesville, VA United States
                [5 ] The George Washington University School of Engineering & Applied Science Washington, DC United States
                Author notes
                Corresponding Author: Virginia LeBaron vtl6k@ 123456virginia.edu
                Author information
                ©Virginia LeBaron, James Hayes, Kate Gordon, Ridwan Alam, Nutta Homdee, Yudel Martinez, Emmanuel Ogunjirin, Tanya Thomas, Randy Jones, Leslie Blackhall, John Lach. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.12.2019.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 14 September 2019
                : 5 October 2019
                : 1 November 2019
                : 5 November 2019

                cancer,pain,sensors,caregivers,smart health,opioids,palliative care
                cancer, pain, sensors, caregivers, smart health, opioids, palliative care


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