Digital Programs for Cancer

(EMBRACE Trial)

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Antidepressants, Antipsychotics

Disqualifiers: Severe depression, Anxiety, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 10 weeks

440 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test the effect of digitally delivered programs on the health, wellbeing, and functioning of newly diagnosed cancer patients. Participants will be randomized to one of two digital programs. Both groups are equally important for the study. Participants will be asked to complete: * Questionnaires. Answers to the questionnaires will help the investigators understand how participants doing through the study. * Modules. Participants will receive access to digital courses developed by experts at Stanford University. * Blood Samples. At home blood collection kits will help the investigators understand how participants' bodies are responding over time. Kits will be sent and returned by mail.

Research Team

Alia J Crum, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: MINDSET Experimental Treatment 1 Intervention

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

Group II: Digital Information Series for Cancer Active Control 1 Intervention

This behavioral intervention provides educational information on coping strategies for individuals undergoing cancer treatment through a hybrid of videos and corresponding questions.

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+