Exploring Mindsets, Beliefs and Resilience Across the Cancer Experience

NCT ID: NCT06705218

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2028-01-30

Brief Summary

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.

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

MINDSET

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Digital Information Series for Cancer

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Currently receiving treatment for severe depression, severe anxiety, bipolar disorder, post-traumatic stress disorder, or schizophrenia.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alia J Crum, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Study Coordinator

Role: CONTACT

embracestudy@stanford.edu

(650) 476-3868

Facility Contacts

Alia Crum Associate Professor

Role: primary

crum@stanford.edu

970-987-9182

Other Identifiers

R01AT012618

Identifier Type: NIH

Identifier Source: secondary_id

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R01AT012618

Identifier Type: NIH

Identifier Source: org_study_id

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