Exploring Mindsets, Beliefs and Resilience Across the Cancer Experience (EMBRACE)

August 24, 2026 updated by: Stanford University

Changing Mindsets to Improve Whole Patient Health: A Randomized Controlled Trial of a Novel mHealth Intervention for People Diagnosed With Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A cancer diagnosis and its subsequent treatment affects whole patient health -- disrupting the full spectrum of physical, social, emotional, and functional quality of life. An estimated 83% of cancer patients report low to very low quality of life. Individuals receiving chemotherapy report experiencing over 13 concurrent symptoms, including fatigue, sleep difficulties, and pain. 30%-40% of people with cancer report significant psychological symptoms, including anxiety and depression. Such disruptions in mental health and quality of life, in turn, exacerbate physical symptoms and can worsen clinical outcomes. Despite growing evidence of the complex, interconnected pathways linking the mind and body, scalable interventions that efficiently target whole-person health upon diagnosis of a life-altering disease such as cancer have not yet been developed. Existing medical treatments, focus on the physiological aspects of the disease. Existing psychological treatments, such as Cognitive Behavior Therapy (CBT) and Mindfulness Based Stress Reduction (MBSR), apply a broad range of cognitive and behavioral strategies to reduce diffuse symptoms of depression and anxiety. Such ancillary programs for psychological care are routinely proposed as methods to reduce distress and symptoms, restore function, and improve quality of life, but they are frequently inaccessible to patients and notoriously difficult to scale. The MINDSET intervention aims to close this major treatment gap and promote whole patient health by targeting patient mindsets at the point of diagnosis. This proposal builds on our extensive foundational research completed over the past 6 years with support of the NIH New Innovator Award (DP2 AT009511) to test a novel mHealth intervention targeting patient mindsets at the point of diagnosis. In our prior research, we showed that a 2.5-hour digital MINDSET intervention significantly improves whole patient health (physical, social, and emotional functioning as measured by the FACT-G) in patients undergoing systemic treatment for cancer with curative intent compared to a Treatment as Usual (TAU) control. Leveraging our interdisciplinary team of experts in oncology, psychology, psychiatry, mHealth, and biostatistics, we aim to expand on this prior research to address this large and costly gap in clinical care. We propose a fully decentralized Phase 3 randomized controlled trial in which 440 cancer patients treated for non-metastatic solid tumors and hematological malignancies will be allocated to either a (1) MINDSET or (2) Matched Attention Control (MAC) condition. Patient-reported primary outcomes (FACT-G Total Score) and secondary outcomes (anxiety, depression, affect, sleep, coping, symptom distress, patient activation/engagement, and inflammatory biology) will be assessed at weeks 0 (baseline), 2, 4, 6, and 10. Durability of the effect of the intervention will be measured at two follow-up timepoints: 3 months, and 6 months after study completion. By promoting health at the psychological, behavioral, and biological levels, MINDSET interventions have the potential to become a highly impactful and complementary tool for promoting whole patient health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
440

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Initial (non-recurrent) diagnosis of non-metastatic (stage I-III) or hematological malignancy.
  • Diagnosis in the past 150 days.
  • Currently receiving active systemic treatment or with a planned systemic treatment (including chemotherapy, immunotherapy or other targeted therapies).
  • Eighteen years of age or older.
  • Fluent in English.
  • Currently reside in the United States.
  • Access to a computer, tablet, or smartphone (a mobile phone that performs many of the functions of a computer, typically including a touchscreen interface, internet access, and an operating system capable of running downloaded applications, or tablet that runs iOS or Android software, with cellular data service or wifi access).

Exclusion Criteria:

  • Failure to meet inclusion criteria.
  • Currently receiving treatment for severe depression, severe anxiety, bipolar disorder, post-traumatic stress disorder, or schizophrenia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MINDSET
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
Behavioral: MINDSET
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 behavior
Active Comparator: Digital Information Series for Cancer
This behavioral intervention provides educational information on coping strategies for individuals undergoing cancer treatment through a hybrid of videos and corresponding questions.
Behavioral: Digital Information Series for Cancer
This behavioral intervention provides educational information on coping strategies for individuals undergoing cancer treatment through a hybrid of videos and corresponding questions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy - General (FACT-G)
Time Frame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Physical, emotional, social and functional quality of life will be assessed using the FACT-G questionnaire. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of quality of life in cancer patients: Physical, social, emotional, and functional well being. Original development and validation involved 854 patients with cancer and 15 oncology specialists.
Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-A)
Time Frame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Anxiety will be measured using the 8 item Patient-Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-A). The PROMIS-A measures fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart,dizziness). The items in the PROMIS negative affect banks use a 7-day time frame and a 5-point rating scale that ranges from 1 ("Never") to 5 ("Always"), with higher scores indicating greater severity of anxiety symptoms. The standardized T-Score for cancer patients reference population is 50 and the minimally clinically important difference (MCID) in T-scores is 3.0-4.5. Anxiety T-scores can be interpreted categorically as ≤55 = normal; 56-60 = mild; 61-70 = moderate; ≥71 = severe.
Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Patient-Reported Outcomes Measurement Information System - Depression Short Form 8b (PROMIS-D)
Time Frame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Depression will be measured using the 8 item the Patient-Reported Outcomes Measurement Information System - Depression Short Form 8b (PROMIS-D). The PROMIS-D content focuses on negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). The items in the PROMIS negative affect banks use a 7-day time frame and a 5-point rating scale that ranges from 1 ("Never") to 5 ("Always"), with higher scores indicating greater severity of depressive symptoms. The standardized T-Score for the cancer patient reference population is 50 and the minimally clinically important difference (MCID) in T-scores is 3.0-4.5. Depression T-Scores can be interpreted categorically as ≤55 = normal; 56-60 = mild; 61-70 = moderate; ≥71 = severe.
Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Positive and Negative Affect (I-PANAS-SF)
Time Frame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Positive and negative affect will be measured by the International version of the Positive and Negative Affect Schedule-Short Form (PANAS-SF). This is a cross-culturally validated version of the widely affect measure that consists of 10 items; 5 items measuring negative affect and 5 items measuring positive affect.
Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance Short Form 8b (PROMIS-Sleep Disturbance)
Time Frame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Sleep disturbance will be measured using the 8 item Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS-Sleep Disturbance). The PROMIS-Sleep Disturbance content focuses on perceptions of sleep quality, sleep depth, and restoration associated with sleep. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
International Physical Activity Questionnaire (IPAQ)
Time Frame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Physical activity will be measured using the 8-tem Short Form of the International Physical Activity Questionnaire (IPAQ). The purpose of the questionnaire is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity by estimating the time spent performing physical activities (moderate to vigorous) and inactivity (time spent sitting).
Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Coping Behaviors- Cancer Behavior Inventory (CBI)
Time Frame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Coping will be measured using the Cancer Behavior Inventory (CBI). The short version of the CBI is a 12-item measure of self-efficacy for coping with cancer. Items are rated on a 5-point Likert scale indicating confidence in a range of coping skills. The CBI yields a single summary score representing overall confidence in engaging in adaptive coping behaviors.
Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Patient Activation Measure (PAM-SF)
Time Frame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
The Patient Activation Measure-Short Form (PAM-SF) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management.
Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Rotterdam Symptom Checklist (RSCL)-Physical Symptom Subscale
Time Frame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Symptom distress will be measured using the 25 item physical symptom distress subscale of the Rotterdam Symptom Checklist (RSCL). All items are rated on a 4-point Likert scale ranging from (1) not at all to (4) very much. Higher scores (calculating by taking the sum of the items) are indicative of greater distress or impairment.
Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Patient Global Impression of Change
Time Frame: Treatment Phase: Weeks 2, 4, 6, 10; Follow Up: Months 3, 6
The Patient Global Impression of Change is a 3 item measure that assesses a patient's perceived improvement (since the start of the study) across 3 domains: Anxiety, Depression, and Global Wellbeing. Items are rated on a 7-point likert scale from 1 (Very much worse) to 7 (Very much improved).
Treatment Phase: Weeks 2, 4, 6, 10; Follow Up: Months 3, 6
Inflammatory activity as measured by a MILLIPLEX Human 48 plex (Millipore)
Time Frame: Treatment Phase: Weeks 0 (Baseline), 4, 10 Follow Up: Months 6
Blood draws will be conducted using at-home blood device such as the Tasso-M20 self-administered home blood sampling method and multiomics testing. The Tasso-M20 device is CE marked and FDA registered. Using the provided kit instructions and contents, subjects will collect the Tasso-M20 blood sample in a self-administered, unsupervised manner which involves attaching the device on their arms for 5 minutes to collect 4 samples of 17.5μLof blood (dry blood spots) (visit Tasso for additional instructions and information) and then ship the device in a pre-labeled envelope back to Stanford where samples will be de-identified and stored in a -80 degree freezer. All de-identified samples will be assayed by the Stanford Human Immune Monitoring Lab (HIMC) using the MILLIPLEX Human 48-plex assay which identifies hormone biomarkers related inflammatory biology.
Treatment Phase: Weeks 0 (Baseline), 4, 10 Follow Up: Months 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alia J Crum, PhD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 43605-1
  • R01AT012618 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Aggregate clinical trials data from all arms of the study will be available on osf.io, the Open Science Framework (OSF), hosted by the Center for Open Science, along with related metadata. Objectives, hypotheses, methods, and analytic plan will be pre-registered on OSF prior to accessing the study data.

IPD Sharing Time Frame

All scientific data generated from this project will be made available at the time of their publication or the end of the funding period, whichever comes first.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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