Objectives/purpose. Scalable interventions that support whole-person health during the early stages of a cancer diagnosis are limited. Mindsets - core beliefs and assumptions that shape how individuals perceive and respond to their experiences - are key drivers of psychological and physical health outcomes. We developed a brief, 2.5-hour digital intervention targeting mindsets about the body (e.g., “my body is capable”) and illness (e.g., “cancer can be an opportunity”). In a prior trial, the intervention significantly improved physical, social, and emotional functioning in individuals with cancer compared to a treatment-as-usual control. This study evaluates its effects on broader psychological, behavioral, and biological outcomes, which have not yet been fully assessed.
Sample and setting. This fully decentralized Phase 3 randomized controlled trial is enrolling 440 adults in the United States who were diagnosed within the past 150 days with non-metastatic solid tumors or hematological malignancies and are receiving curative systemic treatment. Individuals with prior cancer, metastatic disease, or severe psychiatric or cognitive conditions are excluded.
Procedures. All study procedures are conducted remotely using secure digital platforms. Participants are recruited through social media and cancer support communities and randomized to one of two digital programs: ‘MINDSET’ or the ‘Digital Information Series for Cancer (DISC)’. DISC features physicians providing information about cancer and the treatment journey. Both programs consist of three film-based modules delivered over nine weeks via a customized study website. Primary (FACT-G Total) and secondary outcomes (anxiety, depression, affect, sleep, coping, symptom distress, and activation/engagement) are assessed at baseline, weeks 2, 4, 6, and 10, and at 3- and 6-month follow-ups. Immune function is evaluated using self-collected dried blood spots with the Tasso M20 device.
Conclusion and clinical implications. By promoting psychological, behavioral, and biological health, digital mindset interventions may offer a scalable and complementary approach to supporting whole-person care in cancer.