mHealth Intervention for Cancer

(FOCUS Trial)

TO
Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

SW

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

My breast cancer is at stage IV.
Able to read and write in English
My prostate cancer is at stage IV.
See 5 more

Exclusion Criteria

Night-shift work
Untreated bipolar disorder
Substance abuse
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

6 weeks
Weekly telemedicine sessions (15-20 min each)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of symptom severity and quality of life.

12 months
Assessments at 6 and 12 weeks, and 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • mHealth Intervention
Trial Overview The FOCUS program uses cognitive-behavioral therapy (CBT) and acceptance commitment therapy (ACT) delivered through telemedicine to help manage symptoms. The effectiveness of this mHealth intervention will be measured by improvements in sleep, worry-anxiety, depression, and fatigue.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FOCUS Intervention ArmExperimental Treatment1 Intervention
Group II: Information Control ArmPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Ohio University

Collaborator

Trials
73
Recruited
17,800+

Citations

Evaluating the Effectiveness of Mobile Health in Breast ...Mobile health (mHealth) interventions have shown promising opportunities to support breast cancer care. This review analyzes methodologies used ...
Mapping the Evidence on the Impact of mHealth ...All studies contained multiple interventions, including physical activity, tailored information for self-management of the disease, and symptom tracker.
Effect of mobile health (mHealth) on improving anxiety ...This study systematically assesses the effectiveness of mHealth interventions in reducing anxiety and depression and improving QoL in cancer patients.
Evaluating the Effectiveness of a Mobile App for Breast ...mHealth apps have been reported to provide significant benefits for symptom management, patient engagement, and self-efficacy, which in turn ...
The Impact of Mobile Health on Cancer ScreeningThis study found that the use of mobile health applications has a positive impact on health-related behaviours and outcomes.
mHealth Interventions to Improve Cancer Screening and ...Conclusions: mHealth interventions increase cancer screening uptake, although multiple modes used in combination seem to be more effective. J ...
Effect of an mHealth Intervention on Physical Activity ...Precis: Young adult cancer survivors participating in an mHealth intervention did not significantly increase accelerometer-measured total physical activity ...
Mobile health interventions for cancer patient educationThe reported outcomes of mHealth interventions included reduced chemotherapy-related side effects, improved mental health, improved quality of life ...
The impact of mobile health interventions on service users ...mHealth interventions showed positive impacts on clinical outcomes, such as reductions in blood pressure, HbA1c, and cholesterol.
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