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Principal Investigator: Sharla Maelyn Wells-Di Gregorio
Organization: OHIO STATE UNIVERSITY
Fiscal Year: 2024
Award: $656,014
Funding agency: National Cancer Institute
Abstract
People with advanced cancer experience a greater frequency and severity of physical and psychological
symptoms, ranking sleep difficulties, worry-anxiety, depression, and fatigue as four of the most common and
distressing symptoms. These symptoms form a symptom cluster, contribute to functional impairment and
poorer quality of life, and are undertreated, especially in rural communities. There is strong evidence for
biobehavioral interventions to improve these symptoms. However, cognitive-behavioral (CBT) and acceptance
and commitment therapies (ACT) are often too time and energy intensive (e.g., 12-20 sessions) and not
tailored for people with advanced cancer. Preliminary Results. In response to specific needs of people with
advanced cancer, we completed a pilot randomized, controlled trial of a brief, integrated CBT-ACT intervention
utilizing the most effective components of these treatments. Finding Our Center Under Stress (FOCUS) is a
four-module mHealth intervention that teaches patients how to control symptoms, when possible, while
continuing to live meaningfully despite these symptoms. FOCUS participants demonstrated statistically and
clinically significant improvements on insomnia severity (d=-0.98), worry (d=-0.86), depression (d=-0.77),
fatigue interference (d=-0.59), self-report and physiologic sleep efficiency (effect size d=0.92), sleep latency
(d=-0.66), and psychological distress (d =-0.78). The proposed project, guided by the biobehavioral theoretical
model, will build on the success of our pilot trial and complete a larger effectiveness trial of FOCUS compared
to a telemedicine-mHealth information control on this symptom cluster; evaluate dose-response, particularly
among rural patients; and explore biobehavioral mediators of symptom changes. Our primary goal for this
study is to improve this symptom cluster, functional status despite symptoms, and quality of life for people with
advanced cancer from underserved rural communities. Innovative features include our population (50% rural
and Appalachian), symptom cluster focus, telemedicine-mHealth delivery, tailoring for people with advanced
cancer, and use of a biobehavioral approach. Aim 1. Evaluate the effectiveness of FOCUS on a symptom
cluster (sleep-anxiety-depression-fatigue), Aim 2. Determine the impact of FOCUS dose on symptom severity
and interference and examine usage by patient geographic location and gender. Exploratory Aim 3: Examine
biobehavioral mediators of treatment effects. Design and Method: This is a prospective, triple blinded (patient,
research assistant, statistician), single-site, randomized trial of FOCUS vs information control. We will recruit
120 participants with advanced lung, prostate, breast cancer, myeloma, and melanoma. The trial will take
place at The Ohio State University James Comprehensive Cancer Center. All participants will complete
assessments at baseline, 6 and 12 weeks, and 6 and 12 months. We hypothesize that FOCUS participants
who use the app more frequently will demonstrate improvements on the symptom cluster longitudinally
compared to the control group via psychological, inflammatory, and endocrine mediators.
Terms: <Advanced Cancer><Advanced Malignant Neoplasm><Aeroseb-HC><After Care><After-Treatment><Aftercare><Age><Anxiety><Appalachia><Appalachian><Appalachian Region><Appointment><Behavioral><Behavioral Symptoms><Blinded><Breast Cancer><COVID-19><CV-19><Cancer Patient><Cancers><Caring><Cetacort><Clinical Trials><Cognition Therapy><Cognitive><Cognitive Psychotherapy><Cognitive Therapy><Cognitive treatment><Communities><Comprehensive Cancer Center><Control Groups><Coronavirus Infectious Disease 2019><Cort-Dome><Cortef><Cortenema><Cortisol><Cortispray><Cortril><Dermacort><Diagnosis><Diagnostic><Disease><Disorder><Distress><Dose><Drugs><Educational process of instructing><Eldecort><Endocrine><Endocrine Gland Secretion><Equation><Evidence based treatment><Exercise><Fatigue><Frequencies><Functional impairment><Future><Gender><Geographic Area><Geographic Locations><Geographic Region><Geographical Location><Goals><Hormones><Hydrocortisone><Hydrocortone><Hytone><Improve Access><Inflammation><Inflammation Mediators><Inflammatory><Insomnia><Insomnia Disorder><Intervention><Intervention Strategies><Lack of Energy><Learning Skill><Lung><Lung Respiratory System><Malignant Breast Neoplasm><Malignant Melanoma><Malignant Neoplasms><Malignant Tumor><Malignant Tumor of the Lung><Malignant Tumor of the Prostate><Malignant neoplasm of lung><Malignant neoplasm of prostate><Malignant prostatic tumor><Measures><Mediating><Mediator><Medication><Melanoma><Mental Depression><Methods><Mobile Health App><Mobile Health Application><Modeling><Modification><Motivation><Multiple Myeloma><Nutracort><Ohio><Outcome><Palliative Care><Palliative Therapy><Palliative Treatment><Participant><Patient Self-Report><Patients><Persons><Pharmaceutical Preparations><Physiologic><Physiological><Plasma-Cell Myeloma><Population><Proctocort><Prostate><Prostate CA><Prostate Cancer><Prostate Gland><Prostate malignancy><Prostatic Cancer><Prostatic Gland><Psychosocial Assessment and Care><Pulmonary Cancer><Pulmonary malignant Neoplasm><QOL><Quality of life><Randomization trial><Randomized><Randomized, Controlled Trials><Recommendation><Reporting><Research><Research Assistant><Research Support><Rewards><Rural><Rural Community><Self Management><Self-Report><Severities><Site><Sleep><Sleeplessness><Stratification><Stress><Symptom Burden><Symptoms><Teaching><Technology><Telemedicine><Testing><Theoretic Models><Theoretical model><Therapeutic Hormone><Therapeutic Intervention><Time><Underserved Population><Universities><actigraph><actigraphy><active method><active technique><active treatment><ages><alleviate symptom><ameliorating symptom><assess effectiveness><associated symptom><biobehavior><biobehavioral><clinical significance><clinically significant><co-morbid symptom><co-occuring symptom><cognitive behavior intervention><cognitive behavior modification><cognitive behavior therapy><cognitive behavioral intervention><cognitive behavioral modification><cognitive behavioral therapy><cognitive behavioral treatment><comfort care><common symptom><comorbid symptom><compare to control><comparison control><concurrent symptom><cooccuring symptom><coronavirus disease 2019><coronavirus disease-19><coronavirus infectious disease-19><decrease symptom><depression><design><designing><determine effectiveness><drug/agent><effectiveness assessment><effectiveness evaluation><effectiveness study><effectiveness trial><evaluate effectiveness><evidence base><examine effectiveness><experience><fewer symptoms><flexibility><flexible><functional status><geographic site><group intervention><improve symptom><improved><improvement on sleep><inflammatory mediator><innovate><innovation><innovative><intervention therapy><interventional strategy><lung cancer><m-Health><m-Health app><m-Health application><mHealth><mHealth app><mHealth application><mHealth therapeutic><mHealth therapy><mHealth treatment><malignancy><malignant breast tumor><manage symptom><mhealth interventions><mobile app><mobile application><mobile device application><mobile health><mobile health intervention><mobile health therapeutic><mobile health therapy><mobile health treatment><mortality><myeloma><myelomatosis><neoplasm/cancer><online app><participant engagement><patient engagement><physical symptom><pilot trial><post treatment><prospective><psychologic><psychological><psychological distress><psychological symptom><psychosocial assessment><psychosocial care><psychosocial studies><psychosocial support><pulmonary><randomisation><randomization><randomized control trial><randomized effectiveness trial><randomized trial><randomized, clinical trials><randomly assigned><recruit><reduce symptoms><relieves symptoms><response><rural patients><rural under served><rural underserved><sleep difficulty><sleep improvement><success><survivorship><symptom alleviation><symptom association><symptom cluster><symptom comorbidity><symptom improvement><symptom management><symptom reduction><symptom relief><symptomatic improvement><time use><treatment effect><under served community><under served group><under served individual><under served people><under served population><underserved community><underserved group><underserved individual><underserved people><virtual><web app><web application><web based app><web based application>