Clinical trial NCT06705218: Exploring Mindsets, Beliefs and Resilience Across the Cancer Experience
Official title: Changing Mindsets to Improve Whole Patient Health: a Randomized Controlled Trial of a Novel MHealth Intervention for People Diagnosed with Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Mindset
Wellbeing
Resilience
Functioning
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-11-26
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Exclusion Criteria:

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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-A)
timeFrame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
measure: Patient-Reported Outcomes Measurement Information System - Depression Short Form 8b (PROMIS-D)
timeFrame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
measure: Positive and Negative Affect (I-PANAS-SF)
timeFrame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
Other outcomes:
measure: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance Short Form 8b (PROMIS-Sleep Disturbance)
timeFrame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
measure: Coping Behaviors- Cancer Behavior Inventory (CBI)
timeFrame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
measure: Patient Activation Measure (PAM-SF)
timeFrame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
measure: Rotterdam Symptom Checklist (RSCL)-Physical Symptom Subscale
timeFrame: Treatment Phase: Weeks 0 (Baseline), 2, 4, 6, 10 Follow Up: Months 3, 6
measure: Patient Global Impression of Change
timeFrame: Treatment Phase: Weeks 2, 4, 6, 10; Follow Up: Months 3, 6
measure: Inflammatory activity as measured by a MILLIPLEX Human 48 plex (Millipore)
timeFrame: Treatment Phase: Weeks 0 (Baseline), 4, 10 Follow Up: Months 6
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Alia J Crum, PhD
role: PRINCIPAL_INVESTIGATOR
References: