Exploring Mindsets, Beliefs and Resilience Across the Cancer Experience

NCT06705218 | Recruiting DMC

• 1 other identifier: R01AT012618
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Mindset; Wellbeing; Resilience; Functioning

Outcome Measures

Primary Outcomes (1)

• Functional Assessment of Cancer Therapy - General (FACT-G)

  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 Outcomes (3)

• Patient-Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-A)

  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)

  Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6

• Positive and Negative Affect (I-PANAS-SF)

  Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6

Other Outcomes (7)

• Patient-Reported Outcomes Measurement Information System - Sleep Disturbance Short Form 8b (PROMIS-Sleep Disturbance)

  Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6

• International Physical Activity Questionnaire (IPAQ)

  Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6

• Coping Behaviors- Cancer Behavior Inventory (CBI)

  Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6

Study Arms (2)

MINDSET

EXPERIMENTAL

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

Digital Information Series for Cancer

ACTIVE COMPARATOR

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

Interventions

MINDSET 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

MINDSET

Digital Information Series for Cancer BEHAVIORAL

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

Digital Information Series for Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Stress Mindset Measure

Study Officials

• Alia J Crum, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

(650) 476-3868; embracestudy@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: March 20, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)