mHealth Intervention for Cancer
(FOCUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help people with advanced cancer manage symptoms such as sleep problems, anxiety, depression, and fatigue using a mobile health (mHealth) app. The app provides tools and exercises to help patients focus on what matters most, even when facing these challenging symptoms. Participants will use either the app with special exercises or a version with standard information, receiving weekly support through telemedicine (online health services). The trial seeks individuals with advanced lung, breast, prostate, or skin cancer, or multiple myeloma, who experience issues like insomnia or fatigue. As an unphased trial, this study offers a unique opportunity to explore innovative symptom management tools tailored to participants' needs.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this mHealth intervention is safe for cancer patients?
Research shows that mobile health (mHealth) tools are generally easy to use. Past studies have demonstrated that these tools improve mental health and reduce side effects from treatments like chemotherapy. Users of these apps for cancer-related issues have reported feeling better and experiencing fewer symptoms. This suggests that mHealth tools, such as the FOCUS app in this trial, are safe. No major reports of negative effects have emerged, making it a promising option for managing symptoms in advanced cancer.12345
Why are researchers excited about this trial?
Researchers are excited about the mHealth Intervention for cancer patients because it integrates cognitive-behavioral therapy (CBT) and acceptance and commitment therapy (ACT) directly into a mobile app, making mental health support more accessible and personalized. Unlike traditional in-person therapy sessions, this approach allows patients to engage with behavioral and values-based exercises at their convenience, offering flexibility that fits into their daily routines. Additionally, the use of motivational features and rewards in the app encourages consistent practice of skills, which is a fresh approach compared to standard care treatments that often lack these engaging elements. This innovative blend of technology and therapy represents a promising step in enhancing the mental health care of cancer patients.
What evidence suggests that the mHealth intervention is effective for managing symptoms in advanced cancer?
Studies have shown that mobile health (mHealth) tools effectively reduce anxiety and depression and improve the quality of life for cancer patients. Research indicates that mobile health apps help manage symptoms, increase patient involvement, and boost confidence in handling their health. In this trial, participants in the FOCUS Intervention Arm will engage with the FOCUS program, which demonstrated significant improvements in sleep, worry, depression, and tiredness, with strong positive effects. Notably, these sleep improvements persisted even 12 months after treatment. This mobile health approach offers promising support for those dealing with advanced cancer symptoms.36789
Who Is on the Research Team?
Sharla Wells-Di Gregorio, PhD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for advanced cancer patients experiencing symptoms like sleep issues, anxiety, depression, and fatigue. It's especially aimed at those from rural and Appalachian communities. Participants should be willing to use a web-based app as part of the treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the FOCUS intervention, a telemedicine-mHealth symptom management intervention targeting a common symptom cluster for people with advanced cancer. The intervention includes four modules: sleep, worry, fatigue, and mood, each lasting 1.5 hours over a week, for a total of 6 hours across 6 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of symptom severity and quality of life.
What Are the Treatments Tested in This Trial?
Interventions
- mHealth Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Ohio University
Collaborator