Randomized Clinical Trial of a Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Increasing Access in Rural Areas
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
FOCUS Intervention Arm
FOCUS is a standardized mHealth-integrated CBT-ACT biobehavioral intervention divided into four modules. FOCUS includes an introductory video, sleep diary, app overview and a sleep module, worry-uncertainty module, fatigue module, and a mood module (each 1.5 hours spread over a week), for a total of 6 hrs of direct mHealth intervention (not including home practice time) spaced across 6 wks. All modules include behavioral and values-based exercises. The app also features motivational features/rewards for skill-based home practice activities. FOCUS Telemedicine Component. Psychosocial Oncology Fellows (Ph.D. clinical psychologists) will provide minimal contact professional support, connecting with participants via telemedicine for 15-20 min each week to answer questions about skills and home practice after each module. Our project coordinator will respond to any technical or study issues with Moby support, our mobile app design team.
干预措施: mHealth Intervention (Behavioral)
Information Control Arm
Participants will be randomly assigned to an area of the mHealth app specific for control participants. This section of the app will contain a similar video introduction and instructions for use of the app followed by four symptom modules - sleep, worry, fatigue, and mood containing standardized patient information from NCI for each symptom. Control Group Telemedicine Component. Participants will receive weekly minimal contact with a postdoctoral fellow who will assess understanding of NCI symptom management materials with standardized questions focused on that week's material, note information to be reviewed the following week, answer any study-related questions, and record any symptom management practices initiated since reviewing these materials.
干预措施: mHealth Intervention (Behavioral)
结局指标
主要结局
Insomnia Severity Index
时间窗: 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
Generalized Anxiety Disorder
时间窗: 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
时间窗: 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.
Center for Epidemiological Studies Depression Scale
时间窗: 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
时间窗: 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
Symptom Interference/Quality of Life
时间窗: 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.
次要结局
- Biobehavioral Mediators(Baseline, 6 and 12 weeks, and 6 and 12 months)
- CAQ-8 (Committed Action Questionnaire)(Up to 12 months)
- AAQ-II (Acceptance and Action Questionnaire)(Up to 12 months)
- Biobehavioral Mediators(Baseline, 6 and 12 weeks, and 6 and 12 months)
- CAQ-8 (Committed Action Questionnaire)(Up to 12 months)
- AAQ-II (Acceptance and Action Questionnaire)(Up to 12 months)
研究者
Sharla Wells-Di Gregorio
Principal Investigator
Ohio State University Comprehensive Cancer Center