pending amendment

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.

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.

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.

Per NIH Data Sharing Policy, data from this project, including questionnaire data, de-identified demographics and disease information, as well as biomarker data will be shared at the completion of the study via computerized dataset. The investigators do not plan to release data pertaining to participants' individual web-usage as this data is believed to be private and not essential to the overarching purposes or goals of the project. However, the investigators will release summary statistics pertaining to usage (total app usage, frequency of home practice) so Aim 2 of this study can be evaluated by others interested in the web-usage and descriptive features of the study.

A study codebook will be provided outlining the methodology and procedures used to collect the data, variable definitions and labels, scored variable information, and information on the general structure/timepoint labeling of the available data.

The investigators will release data in "waves" relating to publications deriving from this data. For instance, our trial sleep data will be released after Aim 1 is published, our immunology data after Aim 3 is published, and all other data will be available after study is completed via Cancer Data Services. Data will remain available for 15 years. After this time, treatment advances may affect how these diseases are treated and/or symptoms are addressed.

Researchers with certified training in human subjects protections will be able to request access. The investigators will utilize a data sharing agreement that requires 1) a commitment to using the data and codebook only for research purposes, 2) a commitment to securing the data via appropriate computer technology, and 3) a commitment to destroying or returning the data after analyses are complete.

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.