Digital Programs for Cancer
(EMBRACE Trial)
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.12345Why 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Durability of the effect of the intervention is measured at two follow-up timepoints: 3 months and 6 months after study completion.
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?
2
Treatment groups
Experimental Treatment
Active Control
2.5-hour mHealth intervention consisting of three modules containing brief films and corresponding interactive reflection activities aimed to improves whole patient health (physical, social, emotional, and functional quality of life as measured by the FACT-G) in patients undergoing systemic treatment for cancer with curative intent. Films feature interviews with people living with cancer describing their experience with diagnosis, treatment, and recovery, and the importance of their mindsets during their experience. The films also feature Stanford faculty with expertise in oncology, psychiatry, and psychology who offer a scientific framework for the importance of mindsets during cancer treatment and provide examples from their clinical practices. The reflection exercises that follow the films are designed to help patients craft a personalized strategy (a) for changing maladaptive mindsets and maintaining adaptive ones and (b) for translating ideas from the film into actionable behavio
This behavioral intervention provides educational information on coping strategies for individuals undergoing cancer treatment through a hybrid of videos and corresponding questions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
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; “mental ...
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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