440 Participants Needed

Digital Programs for Cancer

(EMBRACE Trial)

SC
Overseen ByStudy Coordinator
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 tests how digital programs can assist individuals recently diagnosed with cancer. The goal is to determine if these programs can enhance patients' health, wellbeing, and daily functioning. Participants will join one of two groups, each engaging in different digital courses and activities, including the Digital Information Series for Cancer and MINDSET. Ideal candidates for this trial have a recent initial diagnosis of non-metastatic cancer, are currently undergoing or planning to undergo systemic treatment, and have access to a digital device like a smartphone or tablet. As an unphased trial, this study provides a unique opportunity to explore innovative digital support tools that could enhance the cancer care experience.

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 seems likely that you can continue your current treatments, as the trial focuses on digital programs for cancer patients.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the digital MINDSET program is safe for cancer patients. In previous studies, this 2.5-hour online course improved patients' overall health, including physical, social, and emotional well-being. No major side effects were reported, indicating it is well-tolerated.

The Digital Information Series for Cancer helps patients manage their treatment. It offers educational content, focusing on guidance and support rather than medical procedures, making it generally safe.

Both programs are online and involve watching videos and answering questions, so they don't carry the same risks as trying new medications. They are designed to support patients' mental and emotional health during cancer treatment.12345

Why are researchers excited about this trial?

Researchers are excited about the "Digital Programs for Cancer" trial because it introduces innovative, digital approaches to support cancer patients beyond standard treatments like chemotherapy, radiation, and surgery. The MINDSET program is unique because it offers a 2.5-hour mobile health (mHealth) intervention that combines films and interactive reflection activities. These components are designed to improve the physical, social, emotional, and functional quality of life for patients by focusing on changing maladaptive mindsets. Additionally, the Digital Information Series for Cancer provides educational content in a hybrid format, helping patients develop coping strategies through engaging videos and questions. These digital interventions are pioneering because they aim to enhance the overall well-being of patients undergoing systemic cancer treatment by addressing the psychological aspects of their journey.

What evidence suggests that this trial's digital programs could be effective for cancer patients?

This trial compares two digital programs for cancer patients. Studies have shown that digital programs like MINDSET, one of the programs in this trial, can significantly improve cancer patients' health. Research indicates that these programs enhance physical, social, and emotional well-being. Patients have reported better mental health, with reduced anxiety and depression, and an improved quality of life. The MINDSET program includes films and reflection exercises that help change negative thoughts and encourage positive thinking. Meanwhile, the Digital Information Series for Cancer, another program in this trial, provides educational content on coping strategies, supporting patients during treatment. Both programs aim to enhance cancer patients' health and well-being through personalized digital experiences.12467

Who Is on the Research Team?

AJ

Alia J Crum, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults in the U.S. who've been recently diagnosed with non-metastatic cancer or blood malignancy and are undergoing or about to start systemic treatment like chemo. They need internet access and a smart device.

Inclusion Criteria

I am fluent in English.
I was diagnosed within the last 150 days.
I have a smartphone, tablet, or computer with internet.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 2.5-hour mHealth intervention consisting of three modules aimed at improving whole patient health, with assessments at weeks 0, 2, 4, 6, and 10.

10 weeks
5 virtual assessments

Follow-up

Durability of the effect of the intervention is measured at two follow-up timepoints: 3 months and 6 months after study completion.

6 months
2 virtual assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Digital Information Series for Cancer
  • MINDSET
Trial Overview The study tests two digital programs on health and wellbeing of cancer patients, involving questionnaires, online modules from Stanford experts, and at-home blood sample kits that participants mail back for analysis.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: MINDSETExperimental Treatment1 Intervention
Group II: Digital Information Series for CancerActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

Citations

Effectiveness of nurse-led mHealth interventions on symptom ...The outcomes were categorized into three major domains: (1) psychological outcomes, including depression, anxiety, and mental health; โ€œmental ...
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.
Positive health outcomes of mindfulness-based ...Among cancer patients, these interventions have demonstrated improvements in mindfulness, social support, well-being, meaningfulness, and spirituality (Carlson ...
Study Details | NCT06705218 | Exploring Mindsets, Beliefs ...In our prior research, we showed that a 2.5-hour digital MINDSET intervention significantly improves whole patient health (physical, social, and emotional ...
Digital Interventions and Mental Health Outcomes in Patients ...This study evaluates the efficacy of digital interventions on mental health outcomes in patients with cancer, with particular focus on ...
Exploring Mindsets, Beliefs and Resilience Across the ...This behavioral intervention provides educational information on coping strategies for individuals undergoing cancer treatment through a hybrid ...
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.
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