Breast Cancer, Lung Cancer, Melanoma, Multiple Myeloma, Prostate Cancer
Conditions
Keywords
symptom management, cancer, rural, sleep, anxiety, worry, fatigue, mood, depression, mHealth, telemedicine, app, advanced cancer, Appalachian
Brief summary
This clinical trial studies whether a telemedicine-mobile health (mHealth) intervention, Finding Our Center Under Stress (FOCUS), improves symptom management in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Patients with advanced cancer often experience difficulties with sleep, worry, fatigue, and sometimes mood. FOCUS uses cognitive-behavioral and acceptance and commitment therapy strategies designed to improve these symptoms. Cognitive-behavioral therapy is a type of counseling focused on how the ways that people think (cognitive) and what they do (behavioral) can change the way they feel. Acceptance and commitment therapy is an intervention which has demonstrated success in treating symptoms by teaching strategies to focus time and energy on valued activities despite symptoms. This may be an effective way for patients with advanced cancer to manage their symptoms.
Detailed description
The investigators will deliver an evidence-based intervention for a common cancer symptom cluster, with clinically significant pilot findings, to rural, underserved people with advanced cancer. The investigators will improve access via a telemedicine- mHealth approach, developed and refined based on the needs and evaluative feedback of people with advanced cancer. The investigators aim to reduce symptom severity and interference via an integrated CBT-ACT intervention. In addition, the investigators will examine the behavioral, hormonal, and inflammatory mechanisms of symptom change including several novel biomarkers identified in the pilot trial (e.g., IL-12, IL-1alpha, TNFbeta). An effective, accessible, brief alternative to medication-based symptom cluster management is essential given the limited availability of palliative and psychosocial care for this population and impact of these symptoms on patient functional status, quality of life, treatment adherence, and survival. The study aligns with NCI's goal to enhance access to clinical trials via telemedicine and mobile applications to better meet the survivorship needs of underserved populations and the goal of RFA CA-22-027 to test interventions to improve delivery of comprehensive survivorship care for individuals with advanced cancer. SPECIFIC AIMS: Aim 1: Evaluate the effectiveness of a telemedicine-mHealth symptom management intervention (FOCUS) targeting a common symptom cluster for people with advanced cancer Aim 2: Determine the impact of FOCUS dose on symptom severity and interference and examine usage by patient geographic location and other demographics Aim 3 (Exploratory): Examine biobehavioral mediators of treatment effects PRIMARY OBJECTIVES: I. Evaluate the effectiveness of a telemedicine-mHealth symptom management intervention (FOCUS) targeting a common symptom cluster for people with advanced cancer. II. Determine the impact of FOCUS dose on symptom severity and interference and examine usage by patient geographic location and gender. EXPLORATORY OBJECTIVE: I. Examine biobehavioral mediators of treatment effects. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients complete four FOCUS modules covering symptoms of insomnia, worry-anxiety, fatigue, and mood over 2-2.5 hours each over 6 weeks. Patients also receive professional support via telemedicine over 20-30 minutes per week for 6 weeks. Additionally, patients undergo blood sample collection throughout the study. ARM II: Patients complete four standardized National Cancer Institute (NCI) modules covering symptoms of sleep, worry, fatigue, and mood over 6 weeks. Patients also receive standardized support via telemedicine over 20-30 minutes per week for 6 weeks. Additionally, patients undergo blood sample collection throughout the study. After completion of study intervention, patients are followed up at 12 weeks and 6 and 12 months.
Interventions
BEHAVIORALmHealth Intervention
Participants are randomized to the FOCUS app or Information Control section of the app and will have six weeks to complete the app. Randomization, via the app, is stratified by geographic location (rural vs other), cancer type, and demographics so experimental arms are equivalent. Participants will complete 5 assessments online over a 12-mo period. The participants will have weekly telehealth professional support during the six-week intervention. Participants wear GeneActiv watches for sleep/activity recording for 7 days and provide blood and saliva samples at baseline, 6 and 12 weeks, and 6 and 12 months.
Sponsors
Ohio State University Comprehensive Cancer Center
Ohio University
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This is a prospective, tripleblind (i.e., patient, research assistant, statistician), single-site, randomized, clinical effectiveness trial of a brief, tailored, minimal contact telemedicine-mHealth symptom management intervention for people with advanced cancer from rural areas.
Intervention model description
The overall goal of this randomized clinical trial is to evaluate the effectiveness of a telemedicine-mHealth symptom cluster intervention, Finding Our Center Under Stress (FOCUS), with people with advanced cancer. The investigators include a telemedicine-mHealth information control condition for comparison.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants will include 120 people with advanced cancer who are ≥ 18 yrs old * Able to read and write in English * Who use internet and e-mail as determined by Computer \& Mobile Device Proficiency Questionnaire. * People with stage IIIb\&c/IV lung cancer, stage IV breast cancer, stage IV prostate cancer, advanced (on active treatment) multiple myeloma, and stage IIIb \& IV melanoma (24 of each cancer type) * meet clinical cut-offs on any two symptoms in this cluster (i.e., ≥ 8 on Insomnia Severity Index (ISI), ≥ 3 on Patient Health Questionnaire-2 for depression, ≥ 2 on Generalized Anxiety Disorder-2, ≥ 3 on Fatigue Symptom Inventory Severity)
Exclusion criteria
* Night-shift work * Untreated bipolar disorder * Substance use disorder * Cognitive impairment per Brief Screen for Cognitive Impairment * Eastern Cooperative Oncology Group performance status of 3 or greater (in bed 50% or more of day), or \<6 mos predicted survival per oncology team. * Prior participation in cognitive behavior therapy will not be an exclusion criterion if individuals meet symptom severity threshold for at least two symptoms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | Baseline, 6 and 12 weeks, and 6 and 12 months | Symptom measures of insomnia will be made using the Insomnia Severity Index, a scale from 0 to 28 with higher scores indicating greater insomnia |
| Center for Epidemiological Studies Depression Scale | Baseline, 6 and 12 weeks, and 6 and 12 months | Symptom measures of depression will be made using the Center for Epidemiological Studies Depression Scale, a scale from 0 to 60 with higher scores indicating more depressive symptoms/more severe depression |
| Fatigue Severity Index | Baseline, 6 and 12 weeks, and 6 and 12 months | Symptom measures of fatigue will be made using the Fatigue Severity Index, a scale from 0 to 110 with higher scores indicating more severe fatigue |
| Generalized Anxiety Disorder | Baseline, 6 and 12 weeks, and 6 and 12 months | Symptom measures of generalized anxiety will be made using the Generalized Anxiety Disorder - 7 (GAD-7), a scale from 0 to 21with higher scores indicating more severe anxiety |
| App Dose and Use | Up to 12 months | The investigators will analyze usage reports of participant engagement with FOCUS mHealth application to assess time reviewing the four FOCUS modules (sleep, worry, depression, fatigue) and overall time using the application to evaluate dose-response on symptoms. The investigators will compare FOCUS usage by geographic location (rural vs other) and demographics and complete detailed examination of clickmaps, screen recordings, and module usage. |
| Symptom Interference/Quality of Life | Baseline, 6 and 12 weeks, 6 and 12 months | The investigators will use the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) five functional sub-scales to assess symptom interference. The subscales will be totaled and the overall scale will range from 0 to 110 with higher scores on functional scales and global health status/quality of life representing better functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biobehavioral Mediators | Baseline, 6 and 12 weeks, and 6 and 12 months | The investigators will test whether symptom severity is mediated by stress hormones (cortisol) and inflammation (IL-12, IL-1alpha, IL-1beta, TNF-alpha, TNFbeta, IL-6, hsCRP, exotaxin) by measuring the levels of each biomarker at various time points throughout the study. |
| CAQ-8 (Committed Action Questionnaire) | Up to 12 months | The investigators will test whether symptom severity is mediated by behavioral changes (committed action - Committed Action Questionnaire). The CAQ-8 scale ranges from 0 to 48 with higher levels indicating a more committed action. |
| AAQ-II (Acceptance and Action Questionnaire) | Up to 12 months | The investigators will test whether symptom severity is mediated by behavioral changes (psychological flexibility - Acceptance and Action Questionnaire). The AAQ-II scale ranges from 7 to 49 with higher scores representing greater psychological inflexibility. This measure will be reverse scored so that higher scores represent greater psychological flexibility to test the mediator hypothesis. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSharla Wells-Di Gregorio, PhD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed